title: A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants

lead_sponsor: Merck Sharp & Dohme LLC

type: Other Grant/Funding Number

ReferenceCitation: Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11.

location_country:
United Kingdom
Italy
United States
Peru
Romania
Philippines
Belgium
South Africa
Japan
Poland
Argentina
Israel
Turkey
Mexico
Malaysia
Canada
China
Denmark
Finland
Thailand
Korea, Republic of
France
Chile
Colombia

location_facility: UH Bristol Education Centre ( Site 2607)

location_facility: St. Marianna University School of Medicine Hospital ( Site 3060)

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2310)

location_facility: Children's National Hospital ( Site 0076)

location_facility: Multicare Health System Institute for Research and Innovation ( Site 0025)

location_facility: FVR, Seinäjoen rokotetutkimusklinikka ( Site 2155)

location_facility: Empilweni Services and Research Unit ( Site 2504)

location_facility: Severance Hospital Yonsei University Health System ( Site 3201)

location_facility: Oxford University Hospital NHS Foundation Trust ( Site 2604)

location_facility: Rutgers University-Pediatric Clinical Research Center ( Site 0055)

location_facility: Szpital im. sw. Jadwigi Slaskiej w Trzebnicy ( Site 2409)

location_facility: Philippine Children s Medical Center ( Site 3154)

location_facility: Ningbo Women and Children's Hospital ( Site 3314)

location_facility: National Hospital Organization Beppu Medical Center ( Site 3063)

location_facility: Clinica del Nino y la Madre ( Site 1005)

location_facility: Midwest Children's Health Research Institute, LLC ( Site 0044)

location_facility: Changde First People's Hospital ( Site 3311)

location_facility: The First People's Hospital of Hangzhou ( Site 3342)

location_facility: FVR, Turun rokotetutkimusklinikka ( Site 2151)

location_facility: Guangdong Provincial People's Hospital ( Site 3341)

location_facility: Jeonbuk National University Hospital ( Site 3210)

location_facility: Clinica Privada del Sol S.A ( Site 1013)

location_facility: Fourth Hospital of Hebei Medical University ( Site 3366)

location_facility: Dalian Women and Children Medical Treatment Center(Hope Square Children's Branch Hospital) ( Site 33

location_facility: Clinica Peruano Americana S.A. ( Site 1253)

location_facility: University Health System- San Antonio ( Site 0048)

location_facility: UPMC Children's Hospital of Pittsburgh - Primary Care Center - Oakland ( Site 0043)

location_facility: Marshall University School of Medicine and Medical Center ( Site 0064)

location_facility: FVR, Oulun rokotetutkimusklinikka ( Site 2158)

location_facility: Groupe Hospitalier Pellegrin ( Site 2218)

location_facility: Northwest Arkansas Pediatric Clinic ( Site 0050)

location_facility: Xiamen Maternity and Child Health Care Hospital ( Site 3351)

location_facility: Hallym University Sacred Heart Hospital ( Site 3207)

location_facility: Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0061)

location_facility: Yuncheng Central Hospital - Eastern Hospital ( Site 3318)

location_facility: FVR, Porin rokotetutkimusklinikka ( Site 2156)

location_facility: Seoul National University Bundang Hospital-Pediatrics ( Site 3204)

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2551)

location_facility: St. Georges University Hospital NHS Foundation Trust ( Site 2601)

location_facility: Alder Hey Childrens NHS Foundation Trust Hospital ( Site 2606)

location_facility: FVR, Järvenpään rokotetutkimusklinikka ( Site 2154)

location_facility: Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2435)

location_facility: Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 1155)

location_facility: Acevedo Clinical Research Associates ( Site 0002)

location_facility: The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 3209)

location_facility: MedStar Georgetown Pediatrics ( Site 0047)

location_facility: Maebashi Red Cross Hospital ( Site 3057)

location_facility: CHU de Quebec Universite de Laval ( Site 0501)

location_facility: Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics ( Site 0093)

location_facility: The Maternal and Child Health Hospital of Hunan Province ( Site 3334)

location_facility: Szpital Bielanski im. Ks. Jerzego Popiełuszki SPZOZ ( Site 2425)

location_facility: Chengdu Women and Children Center Hospital ( Site 3332)

location_facility: Tottori University Hospital ( Site 3053)

location_facility: WIP Warsaw IBD Point Profesor Kierkus ( Site 2441)

location_facility: Aalborg Universitetshospital ( Site 2100)

location_facility: Erciyes University Medical Faculty-pediatric infection ( Site 2554)

location_facility: The Third Affiliated Hospital of Guangzhou Medical University ( Site 3348)

location_facility: Children's Hospital of Fudan University ( Site 3361)

location_facility: Madera Family Medical Group ( Site 0046)

location_facility: Jiangxi Provincial Children's Hospital ( Site 3313)

location_facility: Spitalul Clinic de Urgenta pentru Copii Brasov ( Site 2456)

location_facility: Long Beach Memorial Medical Center ( Site 0014)

location_facility: Guangdong Maternity and Child Health Care Hospital ( Site 3340)

location_facility: Sabah Womens & Childrens Hospital ( Site 3102)

location_facility: Jiangxi Pingxiang People's Hospital ( Site 3312)

location_facility: Ohio Pediatric Research Association ( Site 0063)

location_facility: McGill University Health Centre - Vaccine Study Centre ( Site 0500)

location_facility: Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1252)

location_facility: Renmin Hospital of Wuhan University ( Site 3316)

location_facility: Children's Clinic of Jonesboro, PA ( Site 0058)

location_facility: St.Luke's International Hospital ( Site 3062)

location_facility: Hamilton Medical Research Group ( Site 0509)

location_facility: Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 2423)

location_facility: Pediatric Research of Charlottesville, LLC ( Site 0073)

location_facility: Meridian Clinical Research, LLC ( Site 0083)

location_facility: Spitalul Cinic de Obstretica si Ginecologie Cuza Voda ( Site 2452)

location_facility: Orange County Research Institute ( Site 0057)

location_facility: Hunan Provincial People's Hospital ( Site 3355)

location_facility: Chungang University Hospital ( Site 3211)

location_facility: Jiangjin District Central Hospital ( Site 3319)

location_facility: Sociedad Medica de Rionegro SOMER S.A. ( Site 1157)

location_facility: Centre Hospitalier de Versailles ( Site 2206)

location_facility: University of Utah School of Medicine ( Site 0006)

location_facility: Dartmouth-Hitchcock Medical Center ( Site 0031)

location_facility: Hospital Militar Central Cir Mayor Cosme Argerich ( Site 1001)

location_facility: Zhongda Hospital Southeast University ( Site 3353)

location_facility: University of Calgary - Alberta Children Hospital ( Site 0504)

location_facility: Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 2160)

location_facility: A.O. Policlinico Consorziale di Bari ( Site 2309)

location_facility: FVR, Kokkolan rokotetutkimusklinikka ( Site 2157)

location_facility: Alergo-Med Specjalistyczna Przychodnia Lekarska SP ( Site 2403)

location_facility: Prince of Songkla University Faculty of Medicine ( Site 3255)

location_facility: Maharaj Nakorn Chiang Mai Hospital ( Site 3254)

location_facility: The Children's Hospital of Chongqing Medical University ( Site 3333)

location_facility: Centenario Hospital Miguel Hidalgo ( Site 1204)

location_facility: Cabinet Médical Demeulemeester ( Site 2002)

location_facility: University of the Philippines-Philippine General Hospital ( Site 3152)

location_facility: Far Eastern University - Nicanor Reyes Medical Foundation ( Site 3153)

location_facility: FVR, Espoon rokotetutkimusklinikka ( Site 2152)

location_facility: JOHAS Yokohama Rosai Hospital ( Site 3058)

location_facility: Gazi Universitesi Saglık Arastırma ve Uygulama Merkezi ( Site 2552)

location_facility: Policlinico Universitario Gemelli ( Site 2301)

location_facility: Centrum Medyczne Pratia Warszawa ( Site 2438)

location_facility: Pusan National University Hospital ( Site 3206)

location_facility: Universitair Ziekenhuis Antwerpen ( Site 2001)

location_facility: Southeastern Pediatric Associates, P.A. ( Site 0008)

location_facility: Fukui-ken Saiseikai Hospital ( Site 3064)

location_facility: Soroka University Medical Center Ramot Family health center ( Site 2354)

location_facility: MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 2502)

location_facility: DCOL Center for Clinical Research ( Site 0042)

location_facility: Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 1154)

location_facility: Hunan Shaoyang No.1 People's Hospital ( Site 3345)

location_facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3208)

location_facility: Uniwersytecki Szpital Dzieciecy w Lublinie ( Site 2404)

location_facility: Private Practice - Dr. Etokhana ( Site 0089)

location_facility: Uniwersyteckie Centrum Kliniczne ( Site 2437)

location_facility: Srinagarind Hospital. Khon Kaen University ( Site 3253)

location_facility: Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 2153)

location_facility: Tribe Clinical Research, LLC ( Site 0015)

location_facility: Ege University Medical Faculty ( Site 2553)

location_facility: Centre Hospitalier Universitaire Saint Pierre (Bruxelles) ( Site 2003)

location_facility: Centro de Estudios en Infectologia Pediatrica SAS ( Site 1159)

location_facility: The Third Hospital of Nanchang ( Site 3325)

location_facility: Canadian Center for Vaccinology ( Site 0503)

location_facility: Peking University Third Hospital ( Site 3339)

location_facility: Shizuoka City Shimizu Hospital ( Site 3061)

location_facility: Enhancing Care Foundation-DICRS ( Site 2506)

location_facility: Regionshospitalet Nordjylland ( Site 2102)

location_facility: Hospital Nacional Docente Madre - Nino San Bartolome ( Site 1251)

location_facility: MultiCare Rockwood Cheney Clinic ( Site 0068)

location_facility: Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2555)

location_facility: Meridian Clinical Research, LLC ( Site 0082)

location_facility: Multicare Institute For Research And Innovation ( Site 0045)

location_facility: Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 2440)

location_facility: Instytut Mikroekologii Sp. z.o.o. & Co. Sp. Komandytorowa ( Site 2412)

location_facility: Ageo Central General Hospital ( Site 3051)

location_facility: Hospital Raja Perempuan Zainab II ( Site 3106)

location_facility: CAIMED Investigación en Salud S.A de C.V ( Site 1209)

location_facility: Korea University Ansan Hospital ( Site 3212)

location_facility: Steve Biko Academic Hospital ( Site 2505)

location_facility: Chulalongkorn University-Pediatrics ( Site 3252)

location_facility: University of Texas Medical Branch at Galveston ( Site 0059)

location_facility: Universita degli studi di Padova Patologia e TIN ( Site 2305)

location_facility: Seoul National University Hospital ( Site 3203)

location_facility: FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 2159)

location_facility: Optumcare Colorado Springs, LLC ( Site 0022)

location_facility: Soroka University Medical Center Rahat Family health center ( Site 2355)

location_facility: Children's Hospital Colorado ( Site 0066)

location_facility: MTL Centrum Medyczne Puławska Społka zoo Sp K. ( Site 2426)

location_facility: BC Women s Hospital and Health Centre ( Site 0506)

location_facility: Next Phase Research Alliance, LLC ( Site 0071)

location_facility: Xiangya Hospital Central South University ( Site 3347)

location_facility: Alliance for Multispecialty Research, LLC ( Site 0092)

location_facility: Asociacion Civil Selva Amazonica ( Site 1255)

location_facility: Facultad Medicina Universidad de Chile ( Site 1105)

location_facility: Instituto Nacional de Pediatria ( Site 1202)

location_facility: Javara - Privia Medical Group North Texas - Frisco ( Site 0086)

location_facility: Hebei Petro China Central Hospital ( Site 3365)

summary: The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants. It is hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to placebo.


type: EudraCT Number

title: Randomized, Double-blind, Placebo-controlled, Study of Spesolimab in Patients With Moderate to Severe Hidradenitis Suppurativa

summary:
This study is open to adults with a chronic inflammatory skin disease called hidradenitis suppurativa. The purpose of this study is to find out whether a medicine called spesolimab helps people with moderate to severe hidradenitis suppurativa.

Participants are put into 2 groups by chance. One group takes spesolimab. The other group takes placebo. Every participant has twice the chance of being in the spesolimab group than in the placebo group. Participants get spesolimab or placebo as an infusion into a vein every week for the first 3 weeks. Afterwards, they get spesolimab or placebo as injections under the skin every 2 weeks. Placebo infusions and injections look like spesolimab infusions and injections but do not contain any medicine.

Participants are treated in the study for about 3 months. During this time, they visit the study site about 9 times. After completing this part of the study, participants are offered to join another clinical study in which all participants get spesolimab. Participants who cannot join the other study, stay in this study for about 4 more months. During this time, participants do not take spesolimab nor placebo but they visit the study site 2 times to have their health checked.

At study visits, doctors thoroughly check the skin of participants to count lumps (nodules) and boils (abscesses). The results between the spesolimab group and the placebo group are compared after 3 months of treatment. The doctors also regularly check the general health of the participants.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

lead_sponsor: Boehringer Ingelheim

location_country:
Poland
Spain
Italy
Australia
Netherlands
Canada
United States
France
Belgium
Norway
Germany
Czechia

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Cityclinic Medical and Psychological Clinic Matusiak Partnership

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Dr. S. K. Siddha Medicine Professional Corporation

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


status: Active, not recruiting

acronym: XTEND-Kids

title: A Phase 3 Open-label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Pediatric Patients <12 Years of Age With Severe Hemophilia A

study_completion_date_type: Anticipated

lead_sponsor: Bioverativ, a Sanofi company

type: Other Identifier

source: euctr

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

location_country:
Taiwan
Spain
Ireland
Italy
Australia
Netherlands
Canada
United Kingdom
Switzerland
Sweden
Hungary
United States
France
Turkey
Belgium
Germany

location_facility:
Investigational Site Number :7920004
Investigational Site Number :7920003
Investigational Site Number :8400009
Investigational Site Number :5280001
Investigational Site Number :3800001
Investigational Site Number :8400012
Investigational Site Number :2760002
Investigational Site Number :0560002
Investigational Site Number :2500003
Investigational Site Number :8400001
Investigational Site Number :7240002
Investigational Site Number :0360002
Investigational Site Number :1240004
Investigational Site Number :1580002
Investigational Site Number :8400006
Investigational Site Number :8400002
Investigational Site Number :7560001
Investigational Site Number :8260001
Investigational Site Number :2760001
Investigational Site Number :0360001
Investigational Site Number :8400015
Investigational Site Number :1580004
Investigational Site Number :1240001
Investigational Site Number :8400011
Investigational Site Number :7920001
Investigational Site Number :1580001
Investigational Site Number :7920002
Investigational Site Number :3800002
Investigational Site Number :7240001
Investigational Site Number :1240002
Investigational Site Number :3720001
Investigational Site Number :8400019
Investigational Site Number :2500004
Investigational Site Number :8260003
Investigational Site Number :8400005
Investigational Site Number :1240003
Investigational Site Number :8400003
Investigational Site Number :2500001
Investigational Site Number :8400008
Investigational Site Number :1580003
Investigational Site Number :3480005
Investigational Site Number :5280002
Investigational Site Number :8400020
Investigational Site Number :7520001

summary:
Primary Objective:

- To evaluate the safety of BIVV001 in previously treated pediatric subjects with hemophilia A

Secondary Objectives:

To evaluate the efficacy of BIVV001 as a prophylaxis treatment
To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes
To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes
To evaluate the effect of BIVV001 prophylaxis on joint health outcomes
To evaluate the effect of BIVV001 prophylaxis on Quality of Life (QoL) outcomes
To evaluate the efficacy of BIVV001 for perioperative management
To evaluate the safety and tolerability of BIVV001 treatment
To assess the pharmacokinetics (PK) of BIVV001

status_simplified: Ongoing


title: Valved Graft Post-Market Clinical Follow-up Study

summary: Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.

status: Recruiting

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Abbott Medical Devices

location_country:
Denmark
Poland
Spain
Greece
Austria
Italy
United Kingdom
United States
France
Germany

location_facility: University Hospital - Univ. of Alabama at Birmingham (UAB)

location_facility: Hospital of the University of Pennsylvania

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II

location_facility: Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

location_facility: Groupe Hospitalier Bichat - Claude Bernard

location_facility: The Cardinal Stefan Wyszynski Institute of Cardiology

intervention_type: Device


title: An Open Label, Multicenter Roll-over Extension Program (REP) to Characterize the Long-term Safety and Tolerability of Iptacopan (LNP023) in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Completed PNH Phase 2 and Phase3 Studies With Iptacopan

summary: This study is an open-label, single arm, multicenter, roll-over extension study to characterize long-term safety, tolerability and efficacy of iptacopan and to provide access to iptacopan to patients with PNH who have completed Novartis-sponsored Phase 2 or 3 studies with iptacopan

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Taiwan
Brazil
Spain
Italy
United Kingdom
Netherlands
Lithuania
Korea, Republic of
France
United States
China
Malaysia
Singapore
Japan
Germany
Czechia


title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-64304500 in Patients With Alopecia Areata

summary: The purpose of this study is to evaluate the clinical response of 22 weeks of study intervention with JNJ-64304500, compared with placebo, in participants with moderate to severe alopecia areata (AA).

study_start_date_type: Anticipated

status: Withdrawn

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Japan
Australia
United States
France

location_facility: St George Dermatology & Skin Cancer Centre

location_facility: The Juntendo Tokyo Koto Geriatric Medical Center

location_facility: University of Pittsburgh Department of Dermatology

status_simplified: Unknown


title: A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies

location_country:
Poland
Brazil
Spain
Italy
United Kingdom
Australia
Argentina
Canada
Switzerland
Ukraine
United States
France
Israel
Turkey

location_facility: Medical Oncology Associates (Summit Cancer Centers) ( Site 2710)

location_facility: Szpital Wojewódzki w Opolu-Hematology Department ( Site 1607)

location_facility: The Royal Marsden NHS Foundation Trust. ( Site 2606)

location_facility: Hospital Universitari Vall d'Hebron ( Site 2001)

location_facility: IRCCS Ospedale San Raffaele ( Site 1402)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 2000)

location_facility: Hospital Privado Universitario de Córdoba ( Site 0107)

location_facility: A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1400)

location_facility: Dokuz Eylül Üniversitesi-Hematology ( Site 2402)

location_facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0103)

location_facility: BP - A Beneficencia Portuguesa de São Paulo ( Site 0302)

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2400)

location_facility: Hadassah Ein Karem Jerusalem ( Site 1300)

location_facility: Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 2601)

location_facility: IRCCS - Arcispedale Santa Maria Nuova ( Site 1405)

location_facility: Nepean Hospital-Nepean Cancer Care Centre ( Site 0204)

location_facility: Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site

location_facility: Kyiv City Clinical Hospital 9 ( Site 2502)

location_facility: Hospital Universitario 12 de Octubre ( Site 2003)

location_facility: ASST Spedali Civili di Brescia ( Site 1408)

location_facility: Hospital Universitario de Salamanca ( Site 2002)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0300)

location_facility: Hospital Paulistano - Amil Clinical Research ( Site 0311)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 2704)

location_facility: Centre Hospitalier Lyon-Sud ( Site 0804)

location_facility: The Christie NHS Foundation Trust ( Site 2602)

location_facility: Szpitale Pomorskie Sp. z o.o. ( Site 1600)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1403)

location_facility: Fondazione IRCCS Policlinico San Matteo ( Site 1407)

location_facility: Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 2302)

summary: The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).


title: Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers

acronym: IGuideU

summary: This clinical study is a global, prospective, multi-center, randomized controlled trial to determine if the use of intravascular ultrasound (IVUS) as an adjunctive imaging modality and as an interventional treatment guide will result in a more accurate diagnosis of deep vein occlusion (DVO), will guide optimal therapy, and will provide better clinical outcomes with reduced cost of care for patients presenting with persistent venous leg ulcers (VLUs).

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: Philips Clinical & Medical Affairs Global

location_country:
United Kingdom
Australia
United States
France
Germany

location_facility:
Northwick Park Hospital
Florida Cardiology, P.A.
Englewood Hospital and Medical Center
Atrium Health
CHU Strasbourg
Guys and St. Thomas' Hospital
Klinikum Hochsauerland GmbH
Northwestern
Cardiovascular Institute of the South
Royal Free London NHS Foundation Trust
NYU Langone Health
CH Vichy
Royal Perth Hospital
Vascular Care Connecticut
Vein Center of Southwest Louisiana
C.H.U. Dijon
Wollongong Hospital

intervention_type: Other


title: A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy

summary: The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Poland
Taiwan
Hong Kong
Spain
Greece
Austria
Italy
Mexico
Canada
Russian Federation
Switzerland
Korea, Republic of
United States
Chile
France
Turkey
Colombia
Japan
Bulgaria

location_facility: University of Alabama at Birmingham,Arthritis Clinical Intervention Program

location_facility: Centro de Investigacion Integral Medivest SC

location_facility: New York University Grossman School of Medicine

location_facility: National Hospital Organization Chibahigashi National Hospital

location_facility: I M Sechenov First Medical University of the MoH of RF

location_facility: Università degli studi della Campania Luigi Vanvitelli

location_facility: Diagnostic-Consultative Center Sveti Georgi EOOD

location_facility: Arthritis and Rheumatic Disease Specialties

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Sociedad de prestaciones Medicas y Paramedicas Goecke Gatica y Compania Limitada - Prosalud

location_facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

location_facility: Saint-Petersburg State Budget Healthcare Institution Clinical Rheumatology Hospital 25

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Estudios Clinicos Limitada - Centro de Estudios Reumatologicos

location_facility: University of North Carolina at Chapel Hill Thurston Arthritis Research Center

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

location_facility: Cukurova Universitesi Balcali Hastanesi Saglik Uygulama ve Arastirma Merkezi

location_facility: Institute for Clinical and Translation Research at Einstein and Montefiore Clinical Research Center

location_facility: Hospital of the University of Occupational and Environmental Health Japan

location_facility: Centre for Rheumatology Immunology and Arthritis

location_facility: University of Texas Health Science Center at San Antonio Medical Arts Research Clinic Marc

location_facility: Azienda Ospedaliera Policlinico Umberto I

location_facility: National University Corporation Tohoku University Tohoku University Hospital

location_facility: Centro de Investigacion en Reumatologia y Especialidades Medicas SAS

location_facility: Center for medical consultations and research - practice

location_facility: Azienda Ospedaliero Universitaria Integrata Santa Maria della Misericordia

location_facility: Trinity Universal Research Associates, LLC

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Centrum Badan Klinicznych Wojciech Brzezicki

location_facility: Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

location_facility: Sociedad de Prestaciones Medicas Intermedica Limitada

location_facility: University of California at Los Angeles Medical Center

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: CITER SA de CV (Centro de Investigación y Tratamiento de las Enfermedades Reumáticas SA de CV)

location_facility: University of Pittsburgh Medical Center Lupus Center of Excellence

location_facility: Arizona Arthritis And Rheumatology Associates PC

location_facility: Investigacion y Terapias Reumatologicas Innovadoras LTDA - Interin LTDA

location_facility: Precision Comprehensive Clinical Research Solutions

location_facility: Centro de Estudios de Investigacion Basica y Clinica, Sc

location_facility: Solano y Terront Servicios Medicos Ltda - Uniendo

location_facility: Hospital Clinico Universitario de Santiago

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Centro Integral en Reumatologia SA de CV

location_facility: Centro Integral de Reumatología del Caribe Circaribe SAS

location_facility: Michigan Rheumatology Group, PC - Grand Blanc Office

location_facility: Phylasis Clínicas Research S. De R. L. De C. V.

location_facility: Arizona Arthritis and Rheumatology Associates PC

location_facility: Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

location_facility: Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc

location_facility: Integral Rheumatology and Immunology Specialists

location_facility: Feinstein Institute for Medical Research

location_facility: Reumatop Grzegorz Rozumek, Karin Pistorius

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Limited liability company Scientific Research Medical Complex Your Health

location_facility: Daegu Catholic Universtiy Medcial Center

location_facility: Japan Community Healthcare Organization Chukyo Hospital

location_facility: Olympion Hospital-General Clinic of Patras AE

location_facility: Arthritis and Rheumatology Center of Oklahoma PLLC

location_facility: FSBSI SRI of Rheumatology na V A Nasonova


title: A Phase 2, Multicenter, Open-label, Non-randomized, Proof-of-concept Study Evaluating the Efficacy, Safety, and Tolerability of SAR445088 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

type: Registry Identifier

design_allocation: Non-Randomized

location_country:
Poland
Serbia
Spain
Italy
Netherlands
Canada
United States
France
China
Germany

location_facility: University of Kansas Medical Center-Site Number:8400003

location_facility: University of California Irvine-Site Number:8400002

location_facility: University of Southern California-Site Number:8400004

location_facility: University of South Florida Health- Morsani Center for Advanced Healthcare-Site Number:8400001

summary:
Primary Objectives:

Part A: Efficacy of SAR445088 across three subpopulations of CIDP patients: standard of care (SOC)-Treated, SOC-Refractory and SOC-Naive
Part B:Long-term safety and tolerability of SAR445088 in CIDP

Secondary Objectives:

Part A:

Safety and tolerability of SAR445088 in CIDP
Immunogenicity of SAR445088
Efficacy of SAR445088 with overlapping SOC (SOC-Treated group)

Part B:

Durability of efficacy during long-term treatment with SAR445088 in CIDP
Long-term immunogenicity of SAR445088 in CIDP


title: A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for the Treatment of Unresectable and/or Metastatic Solid Tumors Harboring HER2 Activating Mutations Regardless of Tumor Histology

summary: This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology. The target population are patients who have progressed following prior treatment or who have no satisfactory alternative treatment options, including approved second line therapies in the specific tumor type. Pre-specified HER2 mutations will be locally assessed using NGS tests or alternative methods. Prior HER2 targeting therapy is permitted

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Denmark
Spain
Italy
Canada
Korea, Republic of
United States
France
Belgium
Japan


title: A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination With Systemic Corticosteroids in Ambulatory Subjects With Duchenne Muscular Dystrophy (DMD)

summary: To evaluate the efficacy and safety of pamrevlumab versus placebo in combination with systemic corticosteroids administered every two weeks in ambulatory subjects with Duchenne muscular dystrophy (age 6 to <12 years).

ipd_sharing: Undecided

lead_sponsor: FibroGen

location_country:
Spain
Italy
Austria
Australia
United Kingdom
Canada
United States
France
China
Belgium
Netherlands

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: University of Kansas Medical Center Research Institute

location_facility: University of Massachusetts Memorial Center

location_facility: University of California San Diego Health

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Washington University School of Medicine in St. Louis

location_facility: Centre Hospitalier Universitaire Nantes - Hôtel Dieu

location_facility: University of Iowa Hospitals and Clinics

location_facility: Centre Hospitalier Régional de la Citadelle

location_facility: Children's Hospital of Chongqing Medical University

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: The 1st Affiliated Hospital, Sun Yat-sen University

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

location_facility: University of California Davis Children's Hospital

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Xiangya Hospital Central South University

location_facility: West China Second University Hospital, Sichuan University

location_facility: Children's Hospital of The King's Daughters

location_facility: Ospedale Pediatrico Bambino Gesù - Roma - Gianicolo

location_facility: University of Florida Health Shands Hospital

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico Eugenio Medea - Lombardia

location_facility: Spectrum Health Hospitals Helen DeVos Children's Hospital

location_facility: University of Virginia Children's Hospital

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago


title: A Phase II, Double-blind, Placebo-controlled, Randomized, Cross-over, Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema Due to C1-inhibitor Deficiency Type I and II

lead_sponsor: Pharvaris Netherlands B.V.

location_country:
Poland
Spain
Italy
United Kingdom
Netherlands
Canada
Hungary
United States
France
Israel
Germany
Bulgaria
Czechia

summary: This study evaluates the efficacy of orally administered PHA-022121 for the acute treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are randomized to one of three single doses of PHA-022121 and placebo. The study will compare symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of each dose of PHA-022121 with placebo.


title: A Phase II, Multicenter, Open-Label, Single Arm Study to Evaluate the Pharmacodynamic Effects of Once Weekly Administration of Gantenerumab in Participants With Early (Prodromal to Mild) Alzheimer's Disease

summary: This is a Phase II, multicenter, open-label, single arm, PD study in participants with early (prodromal to mild) AD to evaluate the effect of a once weekly (Q1W) dosing regimen of gantenerumab on deposited amyloid as measured by change from baseline to Week 104 (primary) and Week 208 in brain amyloid positron emission tomography (PET). The administration of gantenerumab as a single injection of Q1W will be investigated in this study, to simplify the dosing regimen for participants.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Spain
Italy
United Kingdom
United States
France
Belgium
Germany

location_facility: Abington Neurological Associates Willow Grove

location_facility: Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)

location_facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

location_facility: Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin

location_facility: Center for Advanced Research & Education

location_facility: ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: Policlínica Guipuzcoa; Servicio de Neurología

location_facility: Senior Sp. Z O.O. Poradnia Psychogeriatryczna

location_facility: Alzheimer's Research and Treatment Center

location_facility: Hospital Universitari i Politecnic La Fe; Servicio de Neurología

location_facility: Gerontopole; Centre de Recherche clinique

location_facility: Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia

location_facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: Surrey and Borders NHS Foundation Trust; Brain Science Research Unit

location_facility: Ospedale Cardinale Panico; Dip.Ricerca Clinica in Neurologia - UO Malattie Neurodegenerative

location_facility: Charing Cross Hospital; Imperial Memory Unit, Level 10 West

location_facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

location_facility: Hospital Universitario de la Princesa; Servicio de Neurologia


title: A Phase 1/2, Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy in Participants With Anemia Due to Myelodysplastic Syndromes or Multiple Myeloma

summary: This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia.

ipd_sharing_description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

lead_sponsor: Incyte Corporation

location_country:
United States
Italy
France

location_facility: Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

location_facility: L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola ? Malpighi

location_facility: Azienda Ospedaliero-Universitaria Careggi (Aouc)


title: A Phase 1, Open-Label, Multicenter Study of INCB106385 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors

summary: This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC)

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

location_country:
Spain
Italy
United Kingdom
United States
France
Belgium

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Cambridge University Hospitals Nhs Foundation Trust

location_facility: South Texas Accelerated Research Therapeutics

location_facility: Imperial College Healthcare Nhs Trust - Hammersmith Hospital

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: University of Maryland - Greenebaum Cancer Center

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: Centro Integral Oncologico Clara Campal (Ciocc)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)

location_facility: Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust

location_facility: Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole


title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

acronym: APPLAUSE-IgAN

summary: The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of LNP023 at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.

ReferenceType: derived

ReferenceCitation: Reich HN, Floege J. How I Treat IgA Nephropathy. Clin J Am Soc Nephrol. 2022 Aug;17(8):1243-1246. doi: 10.2215/CJN.02710322. Epub 2022 Jun 8.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Slovenia
Russian Federation
Australia
Argentina
India
Israel
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Hungary
China
Germany
Denmark
Taiwan
Finland
Thailand
Vietnam
Korea, Republic of
France
Colombia
Netherlands


title: An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC-MPGN

acronym: NOBLE

summary: This is a Phase 2, multicenter, open-label, randomized, controlled study designed to evaluate the safety and efficacy of pegcetacoplan in patients who have post-transplant recurrence of C3G or IC-MPGN.

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
Brazil
Spain
Italy
Austria
Australia
United Kingdom
Argentina
Switzerland
United States
France
Netherlands

location_facility: Hopital Edouard Herriot, Hospices Civils de Lyon

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Clinical Research Center, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Center Hospitalier Universitaire de Montpellier

location_facility: Hospital Universitario Fundacion Favaloro

location_facility: UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP

location_facility: Hospital de Alta Complejidad en Red El Cruce Dr. Nestor Carlos Kirchner

location_facility: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

location_facility: Hospital Universitario 12 de Octubre, Nephrology Department

location_facility: Lille Regional University Hospital Center, Claude Huriez Hospital, Department of Nephrology

location_facility: Keck School of Medicine, University of Southern California

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre


title: A Study Comparing Bi-parametric MRI to Multi-parametric MRI in the Diagnosis of Clinically Significant Prostate Cancer

acronym: PRIME

summary:
This prospective clinical trial (PRostate Imaging using Mri +/- contrast Enhancement (PRIME)) aims to assess whether biparametric MRI (bpMRI) is non-inferior to multiparametric mpMRI (mpMRI) in the detection of clinically significant prostate cancer.

This means that we are comparing MRI scans that requires injection of IV contrast (the current standard practice) versus MRI scans that can be performed without IV contrast in the detection of prostate cancer.

ipd_sharing_description: Anonymised data will be available at request for bona fide researchers with important research questions subject to approval by the study steering committee.

lead_sponsor: University College, London

location_country:
Denmark
Brazil
Spain
Italy
United Kingdom
Australia
Netherlands
Argentina
Canada
Finland
United States
France
Singapore
Belgium
Germany

location_facility: University College London and University College London Hospital

intervention_type: Diagnostic Test

lead_sponsor_type: academique


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of AKCEA-APOCIII-LRx Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)

acronym: BALANCE

summary: The purpose of the study is to evaluate the efficacy of Olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

lead_sponsor: Ionis Pharmaceuticals, Inc.

location_country:
Portugal
Spain
Italy
United Kingdom
Canada
Sweden
Hungary
United States
Israel
France
Norway
Netherlands
Slovakia

location_facility: University of Michigan- Endocrinology & Metabolism

location_facility: Azienda Ospedaliero Universitaria Policlinico Umberto I

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: New York University (NYU) Langone Medical Center

location_facility: Centro Hospitalar de Lisboa Ocidental. E.P.E, - Hospital Santa Cruz

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: West Virginia University Heart and Vascular Institute

location_facility: Assistance Publique - Hopitaux de Marseille

location_facility: Ascension St. Vincent Cardiovascular Research Institute

location_facility: University of California, San Francisco (UCSF) - Medical Center

location_facility: University of Kansas Medical Center (KUMC)

location_facility: Advocate Health and Hospitals Corporation - Lutheran General Hospital

location_facility: Clinique des Maladies Lipidiques de Quebec Inc.

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Hospital da Senhora da Oliveira - Guimaraes

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Manchester University NHS Foundation Trust (MFT)

location_facility: Academic Medical Center - Department of Vascular Medicine

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz

location_facility: Institute de Recherches Cliniques de Montreal

location_facility: Metabolicke centrum MUDr Katariny Raslovej s. r. o.

location_facility: Diabetes/Lipid Management & Research Center

location_facility: The Lipid Clinic (Oslo University Hospital)


title: Non-Interventional, Exploratory, Phase IV, Single-Blind, Cross-Sectional, Randomised, Cross-over Study Evaluating Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease & Hyperkalaemia (APPETIZE).

acronym: APPETIZE

summary: This non-interventional, Phase IV, exploratory, cross-over, randomised, single-blind, active comparator-controlled study has been designed to measure the palatability and preference of Lokelma® versus Veltassa® versus S/CPS in patients with dialysis and non-dialysis chronic kidney disease (CKD) and hyperkalaemia (HK). The sponsor hypothesizes that palatability, in terms of taste, texture, smell, and mouthfeel, will score higher (better) for Lokelma when compared with Veltassa and S/CPS.

time_perspective: Cross-Sectional

ReferenceType: background

ReferenceCitation: Thomsen RW, Nicolaisen SK, Hasvold P, Sanchez RG, Pedersen L, Adelborg K, Egstrup K, Egfjord M, Sørensen HT. Elevated potassium levels in patients with chronic kidney disease: occurrence, risk factors and clinical outcomes-a Danish population-based cohort study. Nephrol Dial Transplant. 2018 Sep 1;33(9):1610-1620. doi: 10.1093/ndt/gfx312.

ReferenceCitation: Laureati P, Xu Y, Trevisan M, Schalin L, Mariani I, Bellocco R, Sood MM, Barany P, Sjölander A, Evans M, Carrero JJ. Initiation of sodium polystyrene sulphonate and the risk of gastrointestinal adverse events in advanced chronic kidney disease: a nationwide study. Nephrol Dial Transplant. 2020 Sep 1;35(9):1518-1526. doi: 10.1093/ndt/gfz150.

ReferenceCitation: Noel JA, Bota SE, Petrcich W, Garg AX, Carrero JJ, Harel Z, Tangri N, Clark EG, Komenda P, Sood MM. Risk of Hospitalization for Serious Adverse Gastrointestinal Events Associated With Sodium Polystyrene Sulfonate Use in Patients of Advanced Age. JAMA Intern Med. 2019 Aug 1;179(8):1025-1033. doi: 10.1001/jamainternmed.2019.0631. Erratum in: JAMA Intern Med. 2020 Feb 24;:.

ReferenceCitation: Zann V, McDermott J, Jacobs JW, Davidson JP, Lin F, Korner P, Blanks RC, Rosenbaum DP. Palatability and physical properties of potassium-binding resin RDX7675: comparison with sodium polystyrene sulfonate. Drug Des Devel Ther. 2017 Sep 6;11:2663-2673. doi: 10.2147/DDDT.S143461. eCollection 2017.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Spain
Italy
Canada
United States
France
Sweden


title: HORIZON: A Phase II, Open-label, Outcomes-assessor Masked, Multicentre, Randomised, Controlled Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration

summary: The purpose of this clinical study is to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD).

lead_sponsor: Gyroscope Therapeutics Limited

location_country:
Poland
Spain
United Kingdom
Australia
United States
France
Germany

location_facility: Northern California Retina Vitreous Associates

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Lübeck

location_facility: The University of Melbourne - The Centre for Eye Research Australia (CERA)

location_facility: Hospital Universitari General de Catalunya

location_facility: University of California- Davis Medical Group Eye Center

location_facility: Oftalmika - Prywatna Klinika Okulistyczna

location_facility: Retina Vitreous Associates Medical Group


title: Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies

summary:
This clinical trial is evaluating a drug called BT8009 alone and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency.

The main goals of this study are to:

Find the recommended dose of BT8009 that can be given safely to participants alone and in combination with pembrolizumab
Learn more about the side effects and effectiveness of BT8009 alone and in combination with pembrolizumab
Learn more about BT8009 alone and in combination with pembrolizumab
Learn more about BT8009 alone in patients with renal insufficiency

lead_sponsor: BicycleTx Limited

location_country:
Spain
Italy
United Kingdom
Canada
United States
France

location_facility: Sarah Cannon Research Institute at HealthONE

location_facility: Next Oncology - Hospital Quironsalud Madrid

location_facility: University Hospitals Cleveland Medical Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Thomas Jefferson University, Sidney Kimmel Cancer Center


title: The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System

summary: prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.

location_country:
Spain
Italy
United Kingdom
Canada
United States
France
Netherlands
Czechia

location_facility: Kansas City Cardiac Arrhythmia Research Foundation

location_facility: Institut de Cardiologie de Quebec (Hospital Laval)

location_facility: University Hospital - University of Alabama at Birmingham (UAB)

location_facility: St. Elizabeth Medical Center - South Unit

location_facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)

location_facility: New York Presbyterian Hospital/Cornell University


acronym: APPLY-PNH

title: A Randomized, Multicenter, Active-comparator Controlled, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily LNP023 in Adult Patients With PNH and Residual Anemia, Despite Treatment With an Intravenous Anti-C5 Antibody.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

location_country:
Taiwan
Brazil
Spain
Italy
United Kingdom
Netherlands
Korea, Republic of
France
United States
Japan
Germany
Czechia

summary: The purpose of this Phase 3 study is to determine whether LNP023 is efficacious and safe for the treatment in PNH through demonstration of superiority of LNP023 compared to anti-C5 antibody treatment in adult PNH patients presenting with residual anemia despite treatment with anti-C5 therapy


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients With Early Stage of Huntington Disease

summary: This study will evaluate the efficacy and safety of pridopidine 45mg twice daily (BID) in patients with early stage manifest Huntington Disease (HD).

lead_sponsor: Prilenia

location_country:
Poland
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
United States
France
Germany
Czechia

location_facility: Prilenia Investigational Site (Site 376)

location_facility: Prilenia Investigational Site (Site 048)

location_facility: Prilenia Investigational Site (Site 333)

location_facility: Prilenia Investigational Site (Site 119)

location_facility: Prilenia Investigational Site (Site 028)

location_facility: Prilenia Investigational Site (Site 032)

location_facility: Prilenia Investigational site (Site 292)

location_facility: Prilenia Investigational Site (Site 385)

location_facility: Prilenia Investigational Site (Site 160)

location_facility: Prilenia Investigational Site (Site 087)

location_facility: Prilenia Investigational Site (Site 386)

location_facility: Prilenia Investigational Site (Site 388)

location_facility: Prilenia Investigational Site (Site 382)

location_facility: Prilenia Investigational Site (Site 176)

location_facility: Prilenia Investigational Site (Site 232)

location_facility: Prilenia Investigational Site (Site 083)

location_facility: Prilenia Investigational Site (Site 098)

location_facility: Prilenia Investigational Site (Site 019)

location_facility: Prilenia Investigational Site (Site 020)

location_facility: Prilenia Investigational Site (Site 378)

location_facility: Prilenia Investigational Site (Site 096)

location_facility: Prilenia Investigational Site (Site 029)

location_facility: Prilenia Investigational Site (Site 076)

location_facility: Prilenia Investigational Site (Site 018)

location_facility: Prilenia Investigational Site (Site 061)

location_facility: Prilenia Investigational Site (Site 393)

location_facility: Prilenia Investigational Site (Site 249)

location_facility: Prilenia Investigational Site (Site 343)

location_facility: Prilenia Investigational Site (Site 326)

location_facility: Prilenia Investigational Site (Site 044)

location_facility: Prilenia Investigational Site (Site 380)

location_facility: Prilenia Investigational Site (Site 384)

location_facility: Prilenia Investigational Site (Site 392)

location_facility: Prilenia Investigational Site (Site 379)

location_facility: Prilenia Investigational Site (Site 017)

location_facility: Prilenia Investigational Site (Site 246)

location_facility: Prilenia Investigational Site (Site 037)

location_facility: Prilenia Investigational Site (Site 027)

location_facility: Prilenia Investigational Site (Site 381)

location_facility: Prilenia Investigational Site (Site 390)

location_facility: Prilenia Investigational Site (Site 030)

location_facility: Prilenia Investigational Site (Site 199)

location_facility: Prilenia Investigational Site (Site 031)

location_facility: Prilenia Investigational Site (Site 239)

location_facility: Prilenia Investigational Site (Site 387)

location_facility: Prilenia Investigational Site (Site 394)

location_facility: Prilenia Investigational Site (Site 051)

location_facility: Prilenia Investigational Site (Site 006)

location_facility: Prilenia Investigational Site (Site 234)

location_facility: Prilenia Investigational Site (Site 228)

location_facility: Prilenia Investigational Site (Site 002)

location_facility: Prilenia Investigational Site (Site 244)

location_facility: Prilenia Investigational Site (Site 180)

location_facility: Prilenia Investigational Site (Site 088)

location_facility: Prilenia Investigational Site (Site 377)

location_facility: Prilenia Investigational Site (Site 175)

location_facility: Prilenia Investigational Site (Site 089)

location_facility: Prilenia Investigational site (Site 291)


intervention_type: Biological

title: An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects With Epstein-Barr Virus-associated Diseases

lead_sponsor: Atara Biotherapeutics

location_country:
Spain
Italy
Austria
United Kingdom
United States
France
Belgium

location_facility: University Hospital Birmingham NHS Foundation Trust (Adults only)

location_facility: University of Maryland Medical Center (Adults only)

location_facility: Sylvester Comprehensive Cancer Center/ University of Miami

location_facility: Cleveland Clinic Taussig Cancer Center (Adults and Pediatrics)

location_facility: Columbia University Irving Medical Center (Adults only)

location_facility: University of Texas Southwestern Medical Center (Pediatrics only)

location_facility: University of California Davis Comprehensive Cancer Center (Adults and Pediatrics)

location_facility: Memorial Sloan-Kettering Cancer Center (Adults and Pediatrics)

location_facility: Great Ormond Street Hospital (Pediatrics only)

location_facility: Oregon Health and Science University (Adults and Pediatrics)

location_facility: Hospital Universitario Ramón y Cajal (Adults only)

location_facility: Azienda Ospedaliero-Universitaria Pisana (Adults only)

location_facility: The Ohio State University - The James Cancer Hospital and Solove Research Institute (Adults only)

location_facility: Ospedale Pediatrico Bambino Gesù (Adults and Pediatrics)

location_facility: Medical University of South Carolina (Adults and Pediatrics)

location_facility: Medizinische Universität Graz (Adults only)

location_facility: The Children's Hospital at Montefiore (Adults and Pediatrics)

location_facility: Uniklinikum Salzburg Landeskrankenhaus (Adults only)

location_facility: Algemeen Ziekenhuis Delta - Campus Rumbeke (Adults only)

location_facility: Hôpital Saint-Eloi (Adults and Pediatrics)

location_facility: Hospital Universitario Viegen del Rocio (Adults and Pediatrics)

location_facility: Children's Hospital of Orange County (Pediatrics [up to 25 years old])

location_facility: University of California Los Angeles (UCLA) (Adults and Pediatrics)

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago (Pediatrics only)

location_facility: Washington University in St. Louis (Adults only)

location_facility: Children's Healthcare of Atlanta (Pediatrics only [up to 25 years old])

location_facility: Hôpital Necker-Enfants Malades (Adults and Pediatrics)

location_facility: Dana Farber Cancer Institute (DFCI) (Adults and Pediatrics)

location_facility: Emory University/Winship Cancer Institute (Adults [>= 16 years])

location_facility: Hôpital Universitaire Pitié Salpêtrière (Adults only)

location_facility: Hôpital Universitaire des Enfants Reine Fabiola (Pediatrics only)

location_facility: University of Michigan Rogel Cancer Center (Adults and Pediatrics)

location_facility: Hospital Universitari Vall d'Hebrón (Adults and Pediatrics)

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan (Adults only)

location_facility: Ospedale Infantile Regina Margherita (Pediatrics only)

location_facility: Lucile Packard Children's Hospital Stanford (Pediatrics only)

location_facility: Medizinische Universität Wien (Adults only)

summary: The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with Epstein-Barr virus (EBV) associated diseases.


title: Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast

acronym: ROSALINE

summary: Despite different clinical characteristics including the response to treatment and the patterns of metastatic relapse, invasive lobular breast carcinoma (ILBC) is treated like invasive ductal breast carcinoma (IDBC) carcinoma both in the clinics and in clinical trials. A large majority of ILBC are ER+/HER2- and almost 90% have loss of E-cadherin (CDH1) expression. A non-clinical study of CDH1 synthetic lethality interactions has identified ROS1 as a potential target. In vivo, ROS1 inhibitors produced profound antitumor effects in multiple models of E-cadherin-defective breast cancer, providing the preclinical rationale for assessing ROS1 inhibitors in this setting. Endocrine therapy being the mainstay of therapy for ER+/HER2- ILBC and the pre-operative setting offering a platform for rapid drug evaluation and biomarker research, the ROSALINE phase 2 study will evaluate the efficacy of Entrectinib (a potent inhibitor of ROS1 among other targets) in combination with letrozole (+ goserelin in premenopausal women) in the early setting of ILBC (stages 1 to 3). The neoadjuvant therapy will last 4 months and post-operative therapy will follow local practice. Biomarker research will include RNA sequencing of initial biopsies and surgical specimens, as well as liquid biopsies.

ReferenceCitation: Agostinetto E, Nader-Marta G, Paesmans M, Ameye L, Veys I, Buisseret L, Neven P, Taylor D, Fontaine C, Duhoux FP, Canon JL, Denys H, Coussy F, Chakiba C, Ribeiro JM, Piccart M, Desmedt C, Ignatiadis M, Aftimos P. ROSALINE: a phase II, neoadjuvant study targeting ROS1 in combination with endocrine therapy in invasive lobular carcinoma of the breast. Future Oncol. 2022 Jul;18(22):2383-2392. doi: 10.2217/fon-2022-0358. Epub 2022 Jun 13. Review.

ReferenceCitation: Okines A, Irfan T, Asare B, Mohammed K, Osin P, Nerurkar A, Smith IE, Parton M, Ring A, Johnston S, Turner NC. Clinical outcomes in patients with triple negative or HER2 positive lobular breast cancer: a single institution experience. Breast Cancer Res Treat. 2022 Apr;192(3):563-571. doi: 10.1007/s10549-021-06432-z. Epub 2022 Feb 4.

lead_sponsor: Jules Bordet Institute

location_country: France Belgium

location_facility:
Institut Bergonié
UZ Brussel
UZ Gent
CHU Namur - Sainte Elisabeth
Grand Hôpital de Charleroi
UZ Leuven
UCL Saint-Luc
Institut Jules Bordet
Institut Gustave Roussy
Institut Curie


title: A Phase 1, First-in-Human, Dose Escalation Study of the JNJ-75348780 Bispecific Antibody Targeting CD3 and CD22 in Participants With NHL and CLL

summary: The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D[s]) and optimal dosing schedule(s) of JNJ-75348780 in participants with relapsed/ refractory B-cell Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) in Part A and to further characterize the safety at the RP2D(s) in Part B.

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country:
Taiwan
Spain
United Kingdom
Australia
Korea, Republic of
Israel
United States
China
France
Japan

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University of Oklahoma Stephenson Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Union Hospital Tongji Medical College of Huazhong University of Science and Technology


title: A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With HER2-positive Metastatic Breast Cancer (DESTINY-Breast07)

summary: DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer

location_country:
Poland
Taiwan
Brazil
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
Korea, Republic of
United States
France
India
Turkey
Germany


title: A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis

acronym: MINT

summary: Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.

lead_sponsor: Viela Bio (acquired by Horizon Therapeutics)

location_country:
Denmark
Poland
Taiwan
Brazil
Belarus
Spain
Italy
Russian Federation
Argentina
Canada
Ukraine
Korea, Republic of
United States
France
China
India
Israel
Japan
Germany
Turkey

location_facility:
Viela Bio Investigative Site - 5306
Viela Bio Investigative Site - 5103
Viela Bio Investigative Site - 1002
Viela Bio Investigative Site - 3901
Viela Bio Investigative Site - 3204
Viela Bio Investigative Site - 2205
Viela Bio Investigative Site - 1016
Viela Bio Investigative Site - 4110
Viela Bio Investigative Site - 4406
Viela Bio Investigative Site - 4108
Viela Bio Investigative Site - 1017
Viela Bio Investigative Site - 4404
Viela Bio Investigative Site - 3202
Viela Bio Investigative Site - 4103
Viela Bio Investigative Site - 3302
Viela Bio Investigative Site - 1013
Viela Bio Investigative Site - 4112
Viela Bio Investigative Site - 4603
Viela Bio Investigative Site - 5703
Viela Bio Investigative Site - 4004
Viela Bio Investigative Site - 4107
Viela Bio Investigative Site - 1103
Viela Bio Investigative Site - 4113
Viela Bio Investigative Site - 1015
VielaBio Investigative Site - 4411
Viela Bio Investigative Site - 4201
Viela Bio Investigative Site - 4006
Viela Bio Investigative Site - 4203
Viela Bio Investigative Site - 4401
Viela Bio Investigative Site - 5101
Viela Bio Investigative Site - 1019
Viela Bio Investigative Site - 4102
Viela Bio Investigative Site - 1018
Viela Bio Investigative Site - 5202
Viela Bio Investigative Site - 1010
Viela Bio Investigative Site - 4602
Viela Bio Investigative Site - 5203
Viela Bio Investigative Site - 5308
Viela Bio Investigative Site - 4008
Viela Bio Investigative Site - 3001
Viela Bio Investigative Site - 4104
Viela Bio Investigative Site - 5602
VielaBio Investigative Site - 3101
Viela Bio Investigative Site - 4606
Viela Bio Investigative Site - 1005
Viela Bio Investigative Site - 5311
Viela Bio Investigative Site - 1003
Viela Bio Investigative Site - 3303
Viela Bio Investigative Site - 1014
Viela Bio Investigative Site - 1020
Viela Bio Investigative Site - 4402
Viela Bio Investigative Site - 3903
Viela Bio Investigative Site - 3301
Viela Bio Investigative Site - 1009
Viela Bio Investigative Site - 4101
Viela Bio Investigative Site - 5105
Viela Bio Investigative Site - 4005
Viela Bio Investigative Site - 5601
Viela Bio Investigative Site - 4111
VielaBio Investigative Site - 4408
Viela Bio Investigative Site - 5702
Viela Bio Investigative Site - 5309
Viela Bio Investigative Site - 1104
Viela Bio Investigative Site - 5104
VielaBio Investigative Site - 2203
Viela Bio Investigative Site - 1006
Viela Bio Investigative Site - 5204
Viela Bio Investigative Site - 1012
Viela Bio Investigative Site - 3002
Viela Bio Investigative Site - 5305
Viela Bio Investigative Site - 4109
Viela Bio Investigative Site - 4604
Viela Bio Investigative Site - 3905
Viela Bio Investigative Site - 5301
Viela Bio Investigative Site - 3402
VielaBio Investigative Site - 4407
Viela Bio Investigative Site - 5304
VielaBio Investigative Site - 2207
Viela Bio Investigative Site - 4413
Viela Bio Investigative Site - 5701
Viela Bio Investigative Site - 3404
Viela Bio Investigative Site - 1008
Viela Bio Investigative Site - 1101
Viela Bio Investigative Site - 4410
Viela Bio Investigative Site - 1001
Viela Bio Investigative Site - 5201
VielaBio Investigative Site - 2206
Viela Bio Investigative Site - 1102
Viela Bio Investigative Site - 4007
VielaBio Investigative Site - 2002
Viela Bio Investigative Site - 4202
Viela Bio Investigative Site - 5106
Viela Bio Investigative Site - 1004
Viela Bio Investigative Site - 5303
Viela Bio Investigative Site - 5302
Viela Bio investigative Site - 4605
Viela Bio Investigative Site - 3003
VielaBio Investigative Site - 2201
Viela Bio Investigative Site - 3201
Viela Bio Investigative Site - 3401
Viela Bio Investigative Site - 1011
Viela Bio Investigative Site - 3403
Viela Bio Investigative Site - 4601
Viela Bio Investigative Site - 4011
Viela Bio Investigative Site - 5312
Viela Bio Investigative Site - 2001
Viela Bio Investigative Site - 1007
Viela Bio Investigative Site - 2003
Viela Bio investigative Site - 4105
Viela Bio Investigative Site - 3902
Viela Bio Investigative Site - 3203


title: A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

summary: This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or ibrutinib to participants from Incyte-sponsored studies of parsaclisib.

location_country:
Denmark
Spain
Italy
United Kingdom
United States
France
Israel
Belgium
Japan
Sweden
Czechia

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Rush University Medical Center - Consultants in Hematology

location_facility: University of Arizona Cancer Center - Out Pt.

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Baylor Scott White Univeristy Medical Center

location_facility: Chru Hopitaux de Tours Hospital Bretonneau

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: California Cancer Associates For Research and Excellence

location_facility: Hospital Universitario Fundacin Jimnez Daz

location_facility: Univerzita Karlova V Praze 1. Lekarska Fakulta

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University of Bologna Institute of Haematology L E A Seragnoli

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara

location_facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori

location_facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah

location_facility: University Hospitals Case Medical Center

location_facility: Knight Cancer Institute At Oregon Health and Science University


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma or Relapsed/Refractory Chronic Lymphocytic Leukemia

summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, combined with acalabrutinib for the treatment of adults with Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia. Participants must be relapsed/refractory (having failed prior therapy)

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Poland
Portugal
United Kingdom
Italy
Australia
Switzerland
Korea, Republic of
United States
France
Belgium
Czechia

location_facility: Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach - Klinika Transplantacji Szpiku i Onkohematologii

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Severance Hospital, Yonsei University Health System

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Centro Ricerche Cliniche di Verona s.r.l.

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii

location_facility: Szpital Uniwersytecki Krakow - Oddzial Kliniczny Hematologii

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho EPE

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE


title: An Open-label, Long Term Safety Trial of Spesolimab Treatment in Patients With Palmoplantar Pustulosis (PPP) Who Have Completed Previous BI Spesolimab Trials

lead_sponsor: Boehringer Ingelheim

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

location_country:
Poland
Taiwan
United Kingdom
Russian Federation
Australia
Canada
Hungary
Korea, Republic of
United States
France
Belgium
Japan
Germany
Czechia

location_facility: The Guenther Dermatology Research Centre

location_facility: SimcoDerm Medical and Surgical Dermatology Centre

location_facility: Dermatovenereological Dispensary #10, St. Petersburg

location_facility: Shiga University of Medical Science Hospital

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Tokyo Dental College Ichikawa General Hospital

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: The Psoriasis Treatment Center of Central New Jersey

location_facility: Total Skin and Beauty Dermatology Center, PC

location_facility: Seoul National University Bundang Hospital

location_facility: Markusovszky University Teaching Hospital

summary:
This study is open to people with palmoplantar pustulosis who took part in previous clinical studies of a medicine called spesolimab. Participants who benefited from spesolimab treatment in the previous studies can join this study.

The purpose of this study is to find out how safe spesolimab is and whether it helps people with palmoplantar pustulosis in the long-term. Participants are in this study for up to 5 years. During this time they visit the study site every month to get spesolimab injections under the skin.

At study visits, doctors check the severity of participants' palmoplantar pustulosis and collect information on any health problems of the participants.


title: A Phase IIb, Randomized, Partially Blind, Active Controlled, Dose-range Finding Study of GSK3640254 Compared to a Reference Arm of Dolutegravir, Each in Combination With Nucleoside Reverse Transcriptase Inhibitors, in HIV-1 Infected Antiretroviral Treatment-naive Adults

acronym: DOMINO

summary: This is a phase 2b, randomized, multicenter, parallel group, partially blind (to GSK3640254 doses [100, 150 and 200 milligrams {mg}]), active controlled clinical trial. It will aim to investigate the safety, efficacy and dose-response of GSK3640254 compared to dolutegravir (DTG), each given in combination with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) (abacavir/lamivudine [ABC/3TC] or emtricitabine/tenofovir alafenamide [FTC/TAF])

ReferenceCitation: Spinner CD, Felizarta F, Rizzardini G, Philibert P, Mitha E, Domingo P, Stephan CJ, DeGrosky M, Bainbridge V, Zhan J, Dumitrescu TP, Jeffrey JL, Xu J, Halliday F, Gan J, Johnson M, Gartland M, Joshi SR, Lataillade M. Phase IIa Proof-of-Concept Evaluation of the Antiviral Efficacy, Safety, Tolerability, and Pharmacokinetics of the Next-Generation Maturation Inhibitor GSK3640254. Clin Infect Dis. 2022 Sep 14;75(5):786-794. doi: 10.1093/cid/ciab1065.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: ViiV Healthcare

location_country:
Portugal
Spain
Italy
Russian Federation
Argentina
Canada
Switzerland
United States
France
South Africa
Germany


title: A Randomized, Double-blind, Dose-ranging, Placebo-controlled, Phase 2a Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Primary Sclerosing Cholangitis (PSC) and Suspected Liver Fibrosis (INTEGRIS-PSC)

summary: A Phase 2a, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study to evaluate the safety, tolerability, and PK of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis

lead_sponsor: Pliant Therapeutics, Inc.

location_country:
United Kingdom
Austria
Australia
Netherlands
Canada
United States
France
Belgium
Germany

location_facility: Indiana University Health University Hospital

location_facility: Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)

location_facility: Saint Antoine Hospital/ Hepatology Department

location_facility: University Medical Center Hamburg -Eppendorf/ I. Dept of Medicine

location_facility: London Health Sciences Centre-University Hospital

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: Department Gastroenterology, Hepatopancreatology and Digestive Oncology CUB Hôpital Erasme

location_facility: Baylor College of Medicine - Advanced Liver Therapies

location_facility: VCU Health Clinical Research Services Unit

location_facility: University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre

location_facility: Toronto Centre for Liver Disease (TCLD), University Health Network, Toronto General Hospital

location_facility: Medical University of Vienna Div. of Gastroenterology and Hepatology

location_facility: Bon Secours Liver Institute of Hampton Roads

location_facility: University of California, Davis Medical Center

location_facility: Northwell Health Center for Liver Diseases

location_facility: Schiff Center of Liver Diseases/University of Miami

location_facility: King's College Hospital NHS Foundation Trust, Denmark Hill

location_facility: Centre Hépato-Biliaire - Hôpital Paul-Brousse

location_facility: California Pacific Medical Center Research Institute

location_facility: John Radcliffe Hospital/Oxford University Hospital


title: A Multi-Center, Open-Label, Phase 2 Study to Evaluate Safety and Efficacy of U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer (CRC)

summary: This study is designed to primarily evaluate the safety and efficacy of U3-1402 in participants with advanced or metastatic colorectal cancer (CRC) who have received at least 2 prior lines of therapy and will explore clinical benefit according to human epidermal growth factor receptor 3 (HER3) tumor expression level in otherwise refractory tumors.

status: Terminated

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Poland
Spain
Italy
United Kingdom
United States
France
Belgium
Japan

location_facility: John Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Northwestern Medical Faculty Foundation NMFF Hematology Oncology

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Asst Grande Ospedale Metropolitano Niguarda

location_facility: VHIO Valle de Hebron Instituto de Oncologia

location_facility: Hospital Universitario HM Sanchinarro, CIOCC

location_facility: M Sklodowska Curie Memorial Cancer Center

location_facility: National Hospital Organization - Osaka National Hospital (ONH)

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Szpital Kliniczny Przemienienia Pańskiego.University Hospital, Chemotherapy Department

location_facility: University of Texas Southwestern Medical Center

location_facility: Hospital del Mar - Institut Hospital del Mar d'Investigacions Mediques IMIM

location_facility: Consorci Corporació Sanitària Parc Taulí de Sabadell

location_facility: MD Anderson Cancer Center University of Texas


title: A Phase 1/2 Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders

summary: This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and expansion.

location_country:
United Kingdom
Italy
Canada
United States
France
Japan

location_facility: Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy

location_facility: Washington University School of Medicine

location_facility: Azienda Ospedaliero-Universitaria Careggi (Aouc)

location_facility: S Orsolas University Hospital Seragnoli Institute of Hematology

location_facility: Emory University - Winship Cancer Institute

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo


title: EXPLORE: A Phase II, Outcomes Assessor-masked, Multicentre, Randomised Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration

acronym: EXPLORE

summary: The purpose of this clinical study is to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD).

location_country:
Spain
United Kingdom
Australia
United States
France
Germany

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Lübeck

location_facility: The University of Melbourne - The Centre for Eye Research Australia (CERA)

location_facility: Hospital Universitari General de Catalunya

location_facility: Clinica Universidad de Navarra - Pamplona


acronym: COMMODORE 1

title: A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors.

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Portugal
Australia
Turkey
Singapore
Sweden
Brazil
Canada
Hungary
Germany
Taiwan
Greece
Ireland
Estonia
Korea, Republic of
France
Netherlands

location_facility: University General Hospital of Alexandroupolis

location_facility: Gaziantep University Medical Faculty Sahinbey Educational Research Hospital; Hematology

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Nucleo de Pesquisa Clinica do Hospital da Crianca

location_facility: MacKay Memorial Hospital; Hematology and oncology

location_facility: Japanese Red Cross Society Suwa Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Marmara University Pendik Training and Research Hospital, Hematology Department

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Cliniques Universitaires Saint-Luc; Pharmacy

location_facility: Szpital Uniwersytecki nr2 im. dr J. Biziela

location_facility: Kobe University Hospital; Medical Oncology and Hematology

location_facility: General Hospital of Thessaloniki G. Papanikolaou

location_facility: Okinawa Tokushukai Takasago Seibu Hospital

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Centro Integrado de Oncologia de Curitiba

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Istanbul University Istanbul Medical Faculty; Neurology

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Indiana Blood & Marrow Transplantation, LLC

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Complejo Hospitalario Universitario de Santiago.

location_facility: Instituto Joinvilense de Hematologia E Oncologia

location_facility: Severance Hospital; Yonsei University Health System

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: National Taiwan Universtiy Hospital; Division of Hematology

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Institut Paoli Calmette; Service d'Hématologie Clinique

location_facility: National Hospital Organization Okayama Medical Center

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol; Hematologia Clinica

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1

location_facility: Hualien Tzu Chi Hospital; Hematology and oncology

location_facility: Hospital Regional Universitario de Malaga

location_facility: Hospital Universitario Walter Cantidio - UFC

location_facility: CHU Rennes - Hopital Pontchaillou; Service d'Hémostase Bioclinique

location_facility: *X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

location_facility: Ege University Medical Faculty; Hematology

location_facility: Hrpc - Health Clinical Research Representation - Eireli

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

summary: A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH currently treated with complement inhibitors. This study will enroll approximately 250 participants.


acronym: PULSAR

title: Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration

lead_sponsor: Bayer

ipd_sharing_description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Serbia
Spain
Italy
Lithuania
Ukraine
United States
Japan
Czechia
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Singapore
Slovakia
Canada
Switzerland
Hungary
China
Bulgaria
Taiwan
Latvia
Georgia
Estonia
Korea, Republic of
France

location_facility: The 1st Affiliated Hospital of Zhejiang University

location_facility: IRCCS Fondazione G.B. Bietti Studio e Ricerca in Otalmologia

location_facility: Spec. Hospital For Active Treatment of Eye Diseases Zora

location_facility: Tianjin Medical University General Hospital

location_facility: Szent-Gyorgyi Albert Orvostudomanyi Egyetem

location_facility: Henan Provincial Ophthalmology Hospital (Henan Eye Institute

location_facility: Beijing Tongren Hospital, Capital Medical University (East)

location_facility: Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Organizacion Medica de Investigacion (OMI)

location_facility: Retina Consultants of Southern California

location_facility: The Affiliated Eye Hospital of Wenzhou Medical College

location_facility: Riga East Clinical University Hospital "Gailezers"

location_facility: Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi

location_facility: Hospital General Universitario de Valencia

location_facility: The 1st Affiliated Hospital Fujian Medical University

location_facility: Hospital of LT University of Health Sciences Kaunas Clinics

location_facility: Arizona Retina and Vitreous Consultants - Research

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Ophthalmic Consultants of the Capital Region

location_facility: Instituto Oftalmológico Francisco Gomez Ulla

location_facility: Private enterprise private production company " Acinus"

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Tokyo Women's Medical University Hospital

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Nemocnica s Poliklinikou Trebisov, Svet zdravia a.s.

location_facility: Shanghai Tongji Hospital of Tongji University

location_facility: Scientific Research Institution of Ophthalmic Diseases

location_facility: The Second Hospital of Anhui medical university

location_facility: Northern California Retina-Vitreous Associates

location_facility: Kansai Medical University Medical Center

location_facility: ALM Oftalmolaser - Oftalmologia Medica e Cirurgica

location_facility: Union Hospt Tongji Medical Colleg. Huazhong univ. Scien&Tech

location_facility: Centro Hospitalar Universitario do Porto

location_facility: Retina Vitreous Associates of Florida - Saint Petersburg

location_facility: Hadassah Hebrew University Hospital Ein Kerem

location_facility: Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: Multiprofile Hospital for Active Treatment Sveta Sofia

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Seoul National University Bundang Hospital

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Retinal Consultants of Texas - San Antonio

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Retina Consultants of Southern Colorado, PC

location_facility: FBSI IRTC Eye Microsurgery n.a. acad. S.N. Fyodorov

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: Beijing Aier Intech Eye Hospital Co. LTD - Ophthalmology

location_facility: Spec. Hosp. for Active Treatment for Eye Diseases Zrenie

location_facility: Kaiser Permanente Riverside Medical Center

location_facility: The First Affiliated Hospital of Xinjiang Medical University

location_facility: The People's Hospital of Ningxia Hui Autonomous Region

location_facility: Japanese Red Cross Wakayama Medical center

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Centre d'Ophtalmologie - Paradis-Monticelli

location_facility: Eye Center of the second Bethune Hospital, jinlin University

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: OFTALMOS, Instituto Oftalmologico de Alta Complejidad

summary: In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.