title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in Pediatric Participants (Ages 10 to 17 Years, Inclusive) With Type 2 Diabetes Mellitus

summary: This study will evaluate the safety and efficacy of ertugliflozin (MK-8835) in pediatric participants with T2DM on metformin with/without insulin. The primary hypothesis of the study is that the addition of ertugliflozin reduces hemoglobin A1C (HbA1C) more than the addition of placebo after 24 weeks of treatment.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Saudi Arabia
Italy
United Kingdom
Ukraine
United States
Costa Rica
Mauritius
Belgium
Philippines
Poland
Russian Federation
Israel
Turkey
Mexico
Malaysia
Canada
Guatemala
Hungary
Dominican Republic
France
Colombia
United Arab Emirates

location_facility: CAIMED Investigación en Salud S.A de C.V ( Site 1008)

location_facility: Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika ( Site 0703)

location_facility: Federal State Budget Institution Endocrinological Research Center ( Site 1611)

location_facility: Consultorio Privado Dr. Geraldine Utrilla ( Site 0501)

location_facility: Vita Verum Medical Egeszsegugyi Szolgaltato Bt ( Site 0706)

location_facility: Unidad Biomedica Avanzada Monterrey S. A. ( Site 1005)

location_facility: Centro De Diabetes Cardiovascular IPS Ltda ( Site 0101)

location_facility: Soroka University Medical Center ( Site 0802)

location_facility: Bashkir State Medical University Hospital ( Site 1603)

location_facility: ICCT Research International, Inc. ( Site 2211)

location_facility: Voronezh State Medical University named after N.N.Burdenko ( Site 1608)

location_facility: Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0001)

location_facility: Cliniques Universitaires Saint-Luc ( Site 2300)

location_facility: MHI Regional Childrens Clinical Hospital ( Site 1908)

location_facility: Rashid Center For Diabetes and Research ( Site 2006)

location_facility: The University of Alabama at Birmingham ( Site 2207)

location_facility: London Health Sciences Centre ( Site 0002)

location_facility: The Children's Hospital of Philadelphia ( Site 2205)

location_facility: Vinnitsa Regional Endocrinology Dispensary, VNMU n.a. M.I.Pyrogov ( Site 1901)

location_facility: Mustafa Al Qaysi Medical Centre ( Site 2010)

location_facility: Consultorio Medico de Endocrinologia Pediatrica ( Site 1002)

location_facility: Center of Excellence in Diabetes and Endocrinology ( Site 2203)

location_facility: SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1914)

location_facility: Kazan State Medical University ( Site 1601)

location_facility: Centro de Investigacion Medica Aguascalientes ( Site 1000)

location_facility: West Middlesex University Hospital ( Site 2104)

location_facility: Hospital Universiti Sains Malaysia ( Site 1102)

location_facility: The Edmond and Lily Safra Children s Hospital ( Site 0804)

location_facility: Institute of Children and Adolescents Health Care of the Academy of Medical Sciences ( Site 1915)

location_facility: Institute for Studies on Diabetes Foundation Inc. ( Site 1402)

location_facility: Cukurova Uni. Tip Fakultesi ( Site 2403)

location_facility: Ukr Center of Endocrine Surgery and Transplatation MOH Ukraine ( Site 1903)

location_facility: Royal London Hospital (Whitechapel) ( Site 2100)

location_facility: King Salman bin Abdulaziz hospital Al Riyadh ( Site 1710)

location_facility: Marmara Üniversitesi Prof. Dr. Asaf Ataseven Hospital ( Site 2400)

location_facility: I. U. Cerrahpasa Tip Fakultesi ( Site 2406)

location_facility: King Abdulaziz Medical City - Al Ahsa ( Site 1730)

location_facility: Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-Gyermekosztály ( Site 0705)

location_facility: Odessa Regional Children Clinical Hospital ( Site 1912)

location_facility: Centro de Investigacion Medica de Occidente S.C. ( Site 1001)

location_facility: Samara City Pediatric Clinical Hospital n.a. N.N. Ivanova ( Site 1610)

location_facility: Centro de Atencion e Investigacion Clinica SC ( Site 1009)

location_facility: MedPlus Medicina Prepagada S.A. ( Site 0102)

location_facility: Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0702)

location_facility: Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktato korhaz ( Site 0704)

location_facility: Al Jalila Children s Specialty Hospital ( Site 2004)

location_facility: Clinical Medical Research Sp. z o.o. ( Site 1511)

location_facility: Bio Investigación AMARC, S.C. ( Site 1006)

location_facility: Siberian State Medical University ( Site 1602)

location_facility: Memorial Regional Hospital-Joe DiMaggio Children's Hospital Division of Pediatric Endocrinology ( Si

location_facility: Thumbay University Hospital ( Site 2001)

location_facility: Rostov Scientific Research Institution of Obstetrics and Pediatry ( Site 1606)

location_facility: Institute of Endocrinology and Metabolism n.a. Komissarenko ( Site 1905)

location_facility: St.Petersburg State Pediatric Medical University ( Site 1600)

location_facility: Poradnia Chorob Metabolicznych. Centrum Zdrowia Tuchow ( Site 1500)

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1003)

location_facility: King Abdul Aziz Medical City - AlRiyadh ( Site 1705)

location_facility: Southern Endocrinology and Associates PA ( Site 2218)

location_facility: King Abdul Aziz Medical City. National Guard Health Affairs ( Site 1715)

location_facility: Coastal Children''s Services ( Site 2202)

location_facility: King Salman bin Abdulaziz hospital - Al Riyadh ( Site 1720)

location_facility: Unidad de Investigacion Clinica Cardiometabolica de Occidente ( Site 1007)

location_facility: Unidad de Medicina Especializada SMA ( Site 1004)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 0709)

location_facility: Chelsea and Westminster Hospital ( Site 2103)

location_facility: Chernivtsi Regional Children Clinical Hospital No. 1-Department of Pediatrics and Medical Genetics (

location_facility: Children's Hospital - Los Angeles ( Site 2201)

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont Gyermekgyogyaszati Klinika ( Site 0708)

location_facility: Instytut Diabetologii Sp z o o ( Site 1512)

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0903)

location_facility: Children's City Clinical Hospital #1 ( Site 1604)

location_facility: Hospital Infantil Dr. Robert Reid Cabral ( Site 0300)

location_facility: West Visayas State University Medical Center ( Site 1401)

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0701)

location_facility: King Abdul Aziz Medical City - AlRiyadh ( Site 1700)

location_facility: University Malaya Medical Centre ( Site 1100)


type: EudraCT Number

title: A Phase 2 Study of TAS-120 in Metastatic Breast Cancers Harboring Fibroblast Growth Factor Receptor (FGFR) Amplifications

summary: The purpose of the trial is to evaluate a patient's response to a Fibroblast Growth Factor Receptor (FGFR) inhibitor, futibatinib (TAS-120), used either alone or in combination with the hormonal therapy, fulvestrant. This study will be conducted in patients with metastatic breast cancer who have specific Fibroblast Growth Factor Receptor gene abnormalities and who have previously received conventional therapies to treat their breast cancer, or who are not able to tolerate certain cancer therapies. This study will also evaluate the safety of taking futibatinib, or futibatinib and fulvestrant, by learning about the potential side effects.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Taiho Oncology, Inc.

location_country:
Portugal
Spain
Italy
United Kingdom
Canada
United States
France

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Instituto Portugues de Oncologia do Porto

location_facility: Centro Hospitalar Universitario Lisboa Norte

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

acronym: BE VITAL

summary: This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).

status: Active, not recruiting

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

lead_sponsor: UCB Biopharma SRL

location_country:
Poland
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
Hungary
United States
France
Belgium
Japan
Germany
Czechia


title: Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, Alone or in Combination With Other Agents, in HLA-A2+ Participants With NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO)

acronym: IGNYTE-ESO

summary: This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors.

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

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Italy
United Kingdom
Canada
United States
France
Netherlands


title: Multicenter, Open-label, Safety and Tolerability Study of Ascending Doses of HepaStem in Patients With Cirrhotic and Pre-cirrhotic Non-alcoholic Steato-hepatitis (NASH)

acronym: PANASH

summary: Multicenter, open-label, safety and tolerability study of ascending doses of HepaStem in patients with cirrhotic and pre-cirrhotic non-alcoholic steato-hepatitis (NASH) to determine the safety and tolerability of ascending single and repeated doses of HepaStem administered to patients with cirrhotic and pre-cirrhotic non-alcoholic steato-hepatitis (NASH)

status: Completed

study_completion_date_type: Actual

lead_sponsor: Promethera Therapeutics

location_country: Bulgaria France Spain Belgium

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: University Multiprofile Hospital for Active Treatment "Tsaritsa Yoana - ISUL"

location_facility: Multiprofile hospital for active treatment (MHAT) Sofia Military Medical Academy

status_simplified: Completed


acronym: BE MOBILE 2

intervention_type: Other

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis

source: euctr

design_allocation: Randomized

location_country:
Poland
Spain
United Kingdom
Netherlands
Hungary
United States
France
China
Turkey
Belgium
Japan
Germany
Bulgaria
Czechia

summary: The purpose of the study is to demonstrate the efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS).


acronym: BE MOBILE 1

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis

location_country:
Poland
Spain
United Kingdom
Hungary
United States
France
China
Turkey
Belgium
Japan
Germany
Bulgaria
Czechia

summary: The purpose of the study is to demonstrate the efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active nonradiographic axial spondyloarthritis (nr-axSpA).


title: PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints): A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Efficacy and Safety of Pegzilarginase in Children and Adults With Arginase 1 Deficiency

summary: CAEB1102-300A is a multi-center randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of pegzilarginase in patients with ARG1-D. This study will consist of a screening period; a randomized, double-blind treatment period; a long-term extension; and a follow up visit for final safety assessments.

lead_sponsor: Aeglea Biotherapeutics

location_country:
United Kingdom
Italy
Austria
Canada
United States
France
Germany

location_facility: Great Ormond Street Hospital for Children

location_facility: Cohen Children's Medical Center (Northwell Health)

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: University of Florida College of Medicine

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

location_facility: University of Texas Health Science Center Medical School at Houston

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


acronym: ILLUMINATE

title: Double-masked, Randomized, Controlled, Multiple-dose Study to Evaluate Efficacy, Safety, Tolerability and Syst. Exposure of QR-110 in Leber's Congenital Amaurosis (LCA) Due to c.2991+1655A>G Mutation (p.Cys998X) in the CEP290 Gene

lead_sponsor: ProQR Therapeutics

location_country:
Brazil
United Kingdom
Italy
Netherlands
Canada
France
United States
Belgium
Germany

location_facility: Federal University of São Paulo - Hospital São Paulo (UNIFESP-HSP)

location_facility: Centre de maladies rares CHNO des Quinze Vingt

location_facility: McGill University Health Centre - Centre for Innovative Medicine

location_facility: INRET Clínica/ Santa Casa de Misericórdia de Belo Horizonte

location_facility: Justus-Liebig Universität - Department of Ophthalmology

location_facility: Amsterdam University Medica Center - Locatie AMC

location_facility: Eye Clinic University of Campania Luigi Vanvitelli

location_facility: The Hospital for Sick Children - SickKids

location_facility: Moorfields Eye Hospital - NHS Foundation Trust

location_facility: University of Tuebingen - Inst. for Ophthalmic Research

summary: The purpose of this double-masked, randomized, controlled, multiple-dose study is to evaluate the efficacy, safety, tolerability and systemic exposure of sepofarsen (QR-110) administered via intravitreal injection in subjects with Leber's Congenital Amaurosis (LCA) due to the CEP290 p.Cys998X mutation after 24 months of treatment


acronym: BE OPTIMAL

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference (Adalimumab) Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

ipd_sharing_description: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.

summary: This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of subjects with active Psoriatic Arthritis (PsA).


title: A Phase Ib, Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Patients With Previously Treated Metastatic, Microsatellite-Stable Colorectal Adenocarcinoma With High CEACAM5 Expression

summary: CO40939 is a Phase Ib, open-label, multicenter, single-arm study designed to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of cibisatamab in combination with atezolizumab administered after pretreatment with obinutuzumab in patients with Stage IV microsatellite stable (MSS) metastatic colorectal cancer (mCRC) whose tumors have high carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) expression and who have progressed on two or more chemotherapy regimens. The study is composed of a safety run-in and an exploratory part.

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:
Denmark
United States
Spain
France

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: START Madrid-FJD, Hospital Fundacion Jimenez Diaz


intervention_type: Biological

title: PHASE 3, OPEN LABEL, SINGLE ARM STUDY TO EVALUATE EFFICACY AND SAFETY OF FIX GENE TRANSFER WITH PF-06838435 (RAAV-SPARK100-HFIX-PADUA) IN ADULT MALE PARTICIPANTS WITH MODERATELY SEVERE TO SEVERE HEMOPHILIA B (FIX:C <=2%) (BENEGENE-2)

lead_sponsor: Pfizer

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Taiwan
Brazil
Saudi Arabia
Greece
United Kingdom
Australia
Canada
Sweden
United States
France
Turkey
Japan
Germany

location_facility: Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti - HEMORIO

location_facility: McMaster University Medical Centre - Hamilton Health Sciences

location_facility: University of California, San Francisco - Outpatient Hematology Clinic

location_facility: St. Vincent Hospital & Health Care Center, Inc.

location_facility: Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP

location_facility: University of California, San Francisco - Clinical Research Center

location_facility: General Hospital of Athens "LAIKO", 2nd Regional Blood Transfusion Center

location_facility: Indiana Hemophilia and Thrombosis Center, Inc

location_facility: Gaziantep University Sahinbey Training and Research Hospital

location_facility: Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti- HEMORIO

location_facility: Skåne University Hospital, Department of Hematology, Oncology and Radiation Physics

location_facility: National Center for Child Health and Development

location_facility: Mississippi Center for Advanced Medicine

location_facility: Juravinski Hospital - Hamilton Health Sciences

location_facility: Hemophilia and Thrombosis Center at the University of Colorado Anschutz Medical Campus

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Universitätsklinikum Bonn, Anstalt des öffentlichen Rechts

location_facility: Hopital Cardiologique Louis Pradel - CRTH

location_facility: King Faisal Specialist Hospital and Research Centre

summary: This study will evaluate the efficacy and safety of PF-06838435 (a gene therapy drug) in adult male participants with moderately severe to severe hemophilia B (participants that have a Factor IX circulating activity of 2% or less). The gene therapy is designed to introduce genetic material into cells to compensate for missing or non-functioning Factor IX. Eligible study participants will have completed a minimum 6 months of routine Factor IX prophylaxis therapy during the lead in study (C0371004). Participants will be dosed once (intravenously) and will be evaluated over the course of 6 years. The main objective of the study will evaluate the annualized bleeding rate [ABR] for participants treated with gene therapy versus standard of care (SOC) therapy (FIX prophylaxis replacement regimen).


title: A Phase 2 Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of DCR-PHXC Solution for Injection (Subcutaneous Use) in Patients With Primary Hyperoxaluria

lead_sponsor: Dicerna Pharmaceuticals, Inc.

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Lebanon
Canada
Netherlands
New Zealand
United States
France
Israel
Romania
Japan
Germany

summary: The purpose of this study is to evaluate the efficacy and safety of DCR-PHXC in Children and Adults with Primary Hyperoxaluria Type 1 (PH1) and Primary Hyperoxaluria Type 2 (PH2)


status: Enrolling by invitation

title: An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial

lead_sponsor: AbbVie

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Spain
United Kingdom
Ukraine
United States
Belgium
Japan
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Turkey
Mexico
Sweden
Canada
Denmark
Taiwan
Greece
Ireland
New Zealand
Korea, Republic of
France

location_facility: Regional Oncological Dispensary /ID# 225195

location_facility: Vehbi Koc vakfi Amerikan Hasta /ID# 225046

location_facility: UCLA Santa Monica Hematology Oncology /ID# 210551

location_facility: Istanbul University Istanbul Medical Faculty /ID# 225045

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 240575

location_facility: General Hospital of Thessaloniki George Papanikolaou /ID# 224088

location_facility: The Royal Wolverhampton NHS Trust /ID# 225164

location_facility: China Medical University Hospital /ID# 224945

location_facility: Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 225194

location_facility: Wellington Regional Hospital /ID# 225593

location_facility: Royal Prince Alfred Hospital /ID# 239557

location_facility: Kobe City Medical Center General Hospital /ID# 241518

location_facility: Swedish Cancer Institute - Edmonds /ID# 213120

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust /ID# 225163

location_facility: Medizinische Universitaet Graz /ID# 223817

location_facility: National Cancer Center Hospital /ID# 241516

location_facility: SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 225474

location_facility: Instytut Hematologii i Transfuzjologii /ID# 225478

location_facility: National Taiwan University Hospital /ID# 224946

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 227017

location_facility: CHU Grenoble - Hopital Michallon /ID# 240497

location_facility: Gabrail Cancer Center Research /ID# 212061

location_facility: University of Arizona Cancer Center - Tucson /ID# 210548

location_facility: CHUQ- Hôpital de l'Enfant-Jesus /ID# 224616

location_facility: National Hospital Organization Mito Medical Center /ID# 241986

location_facility: Dana-Farber Cancer Institute /ID# 215360

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 231132

location_facility: Skane University Hospital Lund /ID# 224747

location_facility: Dartmouth-Hitchcock Medical Center /ID# 210555

location_facility: Centro de Investigacion Clínica Chapultepec SA de CV /ID# 227018

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 225476

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust /ID# 218736

location_facility: King's College Hospital NHS Foundation Trust /ID# 218735

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 225161

location_facility: University College London Hospitals NHS Foundation Trust /ID# 240467

location_facility: University Hospital Plymouth NHS Trust /ID# 218731

location_facility: General Hospital of Athens Laiko /ID# 224087

summary: The purpose of this extension study is to provide venetoclax and obtain long-term safety data for subjects who continue to tolerate and derive benefit from receiving venetoclax in ongoing studies.

status_simplified: Unknown


title: Open Label, Non-randomized Extension Trial to Assess Long Term Safety and Efficacy of Arimoclomol in Subjects With Amyotropic Lateral Sclerosis Who Have Completed the ORARIALS-01 Trial

summary: A multicenter, non-randomized, open label trial, to assess long term safety and efficacy of Arimoclomol in subjects with Amyotrophic Lateral Sclerosis (ALS)who have completed the ORARIALS-01 trial.

status: Terminated

ipd_sharing: Undecided

lead_sponsor: KemPharm Denmark A/S

location_country:
Poland
Spain
Italy
United Kingdom
Netherlands
Canada
Sweden
United States
France
Belgium
Germany

location_facility: Medizinische Hochschule Hannover (MHH) - Klinik fuer Neurologie

location_facility: Centre Hospitalier Regional Universitaire (CHRU) Montpellier - Hopital Gui De Chauliac

location_facility: Hospital Carlos III - Hospital Universitario La Paz, ALS Unit

location_facility: Azienda Ospedaliero Universitaria (AUO) di Torino - Citta'della Salute e della Scienza di Torino

location_facility: Hospital Universitario Vall d'Hebron ALS Unit. Consultas Externas; Office: 9-10-11

location_facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) - Ambulanz fuer ALS und andere Motoneuronenerkrankungen

location_facility: University of Pensylvania, Perelman Center for Advanced Medicine - Penn Neuroscience Center

location_facility: Universitaetsklinikum Ulm - Klinik fuer Neurologie

location_facility: Leonard Wolfson Experimental Neurology Centre

location_facility: Groupe Hospitalier Pitie-Salpetriere - Centre d'Investigation Clinique Neurosciences 1422

location_facility: UC Irvine Health ALS and Neuromuscular Center

location_facility: St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center


type: Other Identifier

title: An International, Prospective Registry Investigating the Natural History of Participants With Achondroplasia

summary:
This is a registry study in children with achondroplasia, age 0-10 years, to be conducted at multiple clinical centers in several countries. Information collected will include in anthropometric characteristics, related symptoms, tests, & treatments

Children's information will be collected in the registry for a maximum of 5 years.

study_type: Observational

time_perspective: Prospective

location_country:
Denmark
Portugal
Spain
Italy
United Kingdom
Australia
Canada
Switzerland
United States
France
China
Belgium
Japan
Germany

location_facility: Centre Hospitalier Universitaire Vaudois -CHUV

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Guy's & St Thomas NHS Trust, St Thomas' Hospital

location_facility: Center for Rare Skeletal Diseases in Childhood and Adolescence

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Newcastle Hospitals NHS Foundation Trust

location_facility: Sheffield Children's NHS Foundation Trust

location_facility: Beijing Children's Hospital, Capital Medical University

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: Alfred I. duPont Hospital for Children - Wilmington

location_facility: Center for Rare Diseases, Department of Pediatrics, Polo Salute Donna e Bambino

location_facility: Centre Hospitalier Univesitaire La Timone

location_facility: Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center


intervention_type: Combination Product

acronym: NeoCOAST

title: A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Subjects With Resectable, Early-stage (I [> 2 cm] to IIIA) Non-small Cell Lung Cancer (NeoCOAST)

lead_sponsor: MedImmune LLC

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:
Portugal
Spain
Italy
Canada
Switzerland
United States
France

summary: Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of neoadjuvant durvalumab alone or in combination with novel agents in participants with resectable, early-stage (Stage I [>2cm] to IIIA) non-small cell lung cancer (NSCLC).


title: Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)

lead_sponsor: Pharmacyclics LLC.

location_country:
Spain
Italy
Austria
Australia
Netherlands
Canada
Russian Federation
United Kingdom
Korea, Republic of
United States
France
Israel
Germany

location_facility: Federal State Budgetary Educational Institution of Higher Professional Education "LP.Pavlov First Saint Petersburg State Medical

location_facility: Cancer Center for Children. The Children's Hospital at Westmead

location_facility: Hospital Universitario Universitario La Paz

location_facility: Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica

location_facility: Safari Day Care, Great Ormond Street Hospital

location_facility: University of Minnesota Masonic Children's Hospital

location_facility: Schneider Children's Medical Center in Israel

location_facility: children's and Women's Health Centre of British Columbia

location_facility: Federal State Budgetary Institution "Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology

location_facility: The Edmond and Lily Safra Children's Hospital

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

location_facility: S.C. Farmacia Pediatrica - Presidio Ospedaliero Infantile Regina Margherita

location_facility: U.O.C. Ematologia Oncoematologia Pediatrica

location_facility: Hospital Infantil Universitario Nino Jesus

summary: Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)


acronym: RUBATO OL

title: Prospective, Multi-center, Single-arm, Open-label Long-term Study Assessing the Safety, Tolerability, and Effectiveness of Macitentan in Fontan-palliated Adult and Adolescent Subjects

lead_sponsor: Actelion

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 Access (YODA) Project site at yoda.yale.edu

location_country:
Denmark
Poland
Taiwan
United Kingdom
Australia
New Zealand
Canada
United States
France
China
Czechia

location_facility: Krakowski Szpital Specjalityczny im. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn

location_facility: Wojewódzki Szpital Specjalistyczny We Wrocławiu

location_facility: Massachusetts General Hospital Heart Center

location_facility: The Prince Charles Hospital, Adult Congenital Heart Disease Unit

location_facility: Providence Medical Research Providence Health Care

summary: The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study (AC-055H301, NCT03153137). This OL trial studies the long-term effect of macitentan in Fontan-palliated patients as it is not known if the effect of macitentan is sustained beyond 52 weeks (end of the parent RUBATO DB study). In addition, the trial also studies the long-term safety of macitentan as this is also unknown. Furthermore, the opportunity will be given to patients who were on placebo in the parent RUBATO DB study to receive macitentan 10 mg and benefit from a potentially active treatment.


acronym: Embolden

title: A Global, Multicenter, Open-label, Matched Historical Control Study of Intrathecal SHP611 in Subjects With Late Infantile Metachromatic Leukodystrophy

lead_sponsor: Shire

type: Registry Identifier

ipd_sharing_description: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants).

location_country:
Brazil
Spain
Greece
Italy
Netherlands
United Kingdom
Argentina
Canada
United States
France
Israel
Belgium
Japan
Germany

location_facility: University of Iowa Stead Family Children's Hospital

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Stollery Children's Hospital University of Alberta

location_facility: New York University Langone Medical Center

location_facility: Los Angeles Biomedical Research Institute at Harbor-UCLA

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

location_facility: IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

summary: The purpose of this study is to evaluate the safety and efficacy of intrathecal (IT) administration of SHP611 on gross motor function, using the Gross Motor Function Classification in Metachromatic Leukodystrophy (GMFC-MLD) compared with matched historical control data in children with metachromatic leukodystrophy (MLD).


title: A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness

acronym: ADAPT+

summary: This is a Long-Term, Single-Arm, Open-Label, Multicenter Phase 3 follow-on trial of the ARGX-113-1704 study to evaluate the safety and tolerability of ARGX-113 in patients with gMG. Patients who have completed at least 1 cycle of treatment and at least 1 year of trial ARGX-113-1705 and have started Part B are eligible to enroll in the open-label trial ARGX-113-2002 to receive efgartigimod by SC administration.

ReferenceType: derived

ReferenceCitation: Howard JF Jr, Bril V, Vu T, Karam C, Peric S, Margania T, Murai H, Bilinska M, Shakarishvili R, Smilowski M, Guglietta A, Ulrichts P, Vangeneugden T, Utsugisawa K, Verschuuren J, Mantegazza R; ADAPT Investigator Study Group. Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2021 Jul;20(7):526-536. doi: 10.1016/S1474-4422(21)00159-9. Erratum in: Lancet Neurol. 2021 Aug;20(8):e5.

lead_sponsor: argenx

location_country:
Denmark
Poland
Serbia
Italy
Georgia
Netherlands
Russian Federation
Canada
Hungary
United States
France
Belgium
Japan
Germany
Czechia

location_facility:
Investigator Site 27
Investigator Site 33
Investigator Site 40
Investigator Site 20
Investigator Site 41
Investigator Site 15
Investigator Site 30
Investigator Site 11
Investigator Site 18
Investigator Site 7
Investigator Site 51
Investigator Site 28
Investigator Site 25
Investigator Site 29
Investigator Site 38
Investigator Site 19
Investigator Site 12
Investigator Site 49
Investigator Site 43
Investigator Site 9
Investigator Site 48
Investigator Site 35
Investigator Site 39
Investigator Site 23
Investigator Site 2
Investigator Site 37
Investigator Site 34
Investigator Site 17
Investigator Site 8
Investigator Site 31
Investigator Site 50
Investigator Site 42
Investigator Site 5
Investigator Site 32
Investigator Site 45
Investigator Site 47
Investigator Site 24
Investigator Site 10
Investigator Site 3
Investigator Site 16
Investigator Site 44
Investigator Site 4
Investigator Site 26
Investigator Site 13
Investigator Site 6
Investigator Site 1
Investigator Site 36
Investigator Site 46
Investigator Site 22
Investigator Site 21
Investigator Site 52
Investigator Site 14


acronym: ATLAS-OLE

title: An Open-label, Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX

lead_sponsor: Genzyme, a Sanofi Company

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:
Denmark
Taiwan
United Kingdom
Ireland
Italy
Australia
Canada
Ukraine
Hungary
Korea, Republic of
United States
France
China
India
Israel
Japan
Germany
Malaysia
South Africa
Turkey

location_facility:
Investigational Site Number :7920004
Investigational Site Number :7920003
Investigational Site Number :3760001
Investigational Site Number :4100003
Investigational Site Number :8400009
Investigational Site Number :1560010
Investigational Site Number :8400012
Investigational Site Number :3920005
Investigational Site Number :1560004
Investigational Site Number :7920005
Investigational Site Number :1560005
Investigational Site Number :8400001
Investigational Site Number :1560003
Investigational Site Number :2500003
Investigational Site Number :0360002
Investigational Site Number :3920003
Investigational Site Number :8400007
Investigational Site Number :1580002
Investigational Site Number :8260004
Investigational Site Number :7920006
Investigational Site Number :8260001
Investigational Site Number :4580001
Investigational Site Number :1580005
Investigational Site Number :8400002
Investigational Site Number :8400006
Investigational Site Number :1560007
Investigational Site Number :3480002
Investigational Site Number :3560005
Investigational Site Number :3920008
Investigational Site Number :1580007
Investigational Site Number :2500002
Investigational Site Number :8040001
Investigational Site Number :2760001
Investigational Site Number :0360001
Investigational Site Number :8400016
Investigational Site Number :1560008
Investigational Site Number :1560002
Investigational Site Number :3560007
Investigational Site Number :0360003
Investigational Site Number :1240001
Investigational Site Number :1560011
Investigational Site Number :8400011
Investigational Site Number :3560010
Investigational Site Number :1560013
Investigational Site Number :3720002
Investigational Site Number :1580004
Investigational Site Number :3800004
Investigational Site Number :1580008
Investigational Site Number :1580001
Investigational Site Number :7920002
Investigational Site Number :3920001
Investigational Site Number :4580002
Investigational Site Number :8040003
Investigational Site Number :3800002
Investigational Site Number :4100002
Investigational Site Number :7920007
Investigational Site Number :3560002
Investigational Site Number :2760003
Investigational Site Number :8040002
Investigational Site Number :1560012
Investigational Site Number :3720001
Investigational Site Number :3920004
Investigational Site Number :8400019
Investigational Site Number :2080001
Investigational Site Number :7920008
Investigational Site Number :8040004
Investigational Site Number :4100001
Investigational Site Number :3560001
Investigational Site Number :3920002
Investigational Site Number :4580003
Investigational Site Number :1560006
Investigational Site Number :8400008
Investigational Site Number :1580003
Investigational Site Number :3560004
Investigational Site Number :7920012
Investigational Site Number :1560014
Investigational Site Number :1560009
Investigational Site Number :4100004
Investigational Site Number :7100002

summary:
Primary Objective:

To characterize the long-term safety and tolerability of fitusiran

Secondary Objectives:

To characterize the efficacy and long-term efficacy of fitusiran as assessed by the frequency of:

Bleeding episodes
Spontaneous bleeding episodes
Joint bleeding episodes
To characterize the effects of fitusiran on health-related quality of life (HRQOL) measures in participants ≥17 years of age


title: An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease

acronym: EAGLE

summary: This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with bardoxolone methyl. Patients will remain in the study until bardoxolone methyl is available through commercial channels or until patient withdrawal, whichever is sooner.

lead_sponsor: Reata Pharmaceuticals, Inc.

location_country:
Spain
Australia
Puerto Rico
United States
France
Japan

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Washington University School of Medicine

location_facility: Nephrology Research NorthShore University Health System

location_facility: Arizona Kidney Disease and Hypertension Research Services, PLLC

location_facility: Puerto Rico Clinical and Translational Research Consortium (PRCTRC)

location_facility: University of California San Francisco - Children's Renal Center

location_facility: Tokyo Metropolitan Children's Medical Center

location_facility: Mountain Kidney & Hypertension Associates

location_facility: Hopital Necker, Universite Paris Descartes

location_facility: Tufts Medical Center - Division of Nephrology

location_facility: South Carolina Nephrology & Hypertension Center, Inc


title: A Phase 3 Trial of Setmelanotide (RM-493), a Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Patients With Moderate to Severe Obesity

lead_sponsor: Rhythm Pharmaceuticals, Inc.

ReferenceCitation: Haqq AM, Chung WK, Dollfus H, Haws RM, Martos-Moreno GÁ, Poitou C, Yanovski JA, Mittleman RS, Yuan G, Forsythe E, Clément K, Argente J. Efficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alström syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period. Lancet Diabetes Endocrinol. 2022 Nov 7. pii: S2213-8587(22)00277-7. doi: 10.1016/S2213-8587(22)00277-7. [Epub ahead of print]

ReferenceCitation: Haws RM, Gordon G, Han JC, Yanovski JA, Yuan G, Stewart MW. The efficacy and safety of setmelanotide in individuals with Bardet-Biedl syndrome or Alstrom syndrome: Phase 3 trial design. Contemp Clin Trials Commun. 2021 May 3;22:100780. doi: 10.1016/j.conctc.2021.100780. eCollection 2021 Jun.

location_country:
Spain
United Kingdom
Canada
Puerto Rico
United States
France

location_facility: Universidad Autónoma de Madrid University Hospital Niño

location_facility: University of Tennessee Health Science Center

location_facility: Sorbonne University Pitié-Salpêtrière Hospital

location_facility: UMMS Baystate Health; BAYSTATE MEDICAL CENTER; Baystate Children's Specialty Center

summary: This pivotal, phase 3 study is designed to confirm the efficacy and safety of setmelanotide, a potent melanocortin receptor type 4 (MC4R) agonist, for the treatment of obesity and hyperphagia in patients with Bardet Biedl syndrome (BBS) or Alström syndrome (AS). The study's primary efficacy endpoint will evaluate the proportion of patients (≥12 years of age at baseline) who lose ≥10% of their baseline body weight following approximately (~) 52 weeks of treatment with setmelanotide compared to a historical control rate. The study will consist of 3 treatment periods. Eligible patients will enter a 14 week, randomized, double-blind, placebo-controlled treatment period (Period 1) that will be followed by a 38 week open label treatment period (Period 2) in which all patients will receive setmelanotide. The primary analysis will be performed after Period 2. Following Period 2, patients will continue open-label treatment for 14 weeks (Period 3) after which they may be enrolled into a separate treatment extension study.


title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Subjects With Moderate to Severe Systemic Lupus Erythematosus (SLE)

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Philippines
Czechia
Poland
Russian Federation
Israel
Turkey
Mexico
Hungary
Bulgaria
Taiwan
Greece
Georgia
Thailand
France
Chile

location_facility: Angeles University Foundation Medical Center

location_facility: Municipal institution "Regional Clinical Hospital n.a. O.F. Herbachevskoho"

location_facility: Unidad de Atención Médica e Investigación en Salud

location_facility: Non-governmental private healthcare organization, Scientific Clinical Centre of JSC Russian Railways

location_facility: Centre Hospitalier Regional Universitaire Brest Hôpital de la Cavale Blanche à Brest

location_facility: State University of New York Upstate Medical University

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz Rendelointezet

location_facility: Centro de Atención e Investigación Cardiovascular del Potosí, S.C.

location_facility: Śląskie Centrum Reumatologii, Rehabilitacji i Zapobiegania Niepełnosprawności im gen. Jerzego Zi

location_facility: Necmettin Erbakan Üniversitesi Meram Tıp Fakültesi

location_facility: Center for Rheumatology Immunology and Arthritis

location_facility: Far Eastern University - Nicanor Reyes Medical Foundation

location_facility: Consultorio Particular Dr. Miguel Cortés Hernández

location_facility: State Institution of Health Protection "Clinical Hospital #8"

location_facility: Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed

location_facility: Guy's and Saint Thomas' NHS Foundation Trust

location_facility: Szpital Uniwersytecki Number 2 im. dr. Jana Biziela w Bydgoszczy

location_facility: Diagnostic and Consulting Center "Aleksandrovska" EOOD

location_facility: Consultorio Médico del Dr. Federico Galván Villegas

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Hospital Universitario "Dr. Gonzalo Valdés Valdés"

location_facility: Centro Integral en Reumatología S.A. de C.V.

location_facility: Zakarpattya Regional Clinical Hospital n.a. A.Novak - Rheumatology Department

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Szpital Specjalistyczny im. J. Dietla w Krakowie

location_facility: Poltava Regional Clinical Hospital named after M.V. Sklifossovsky

location_facility: Morales Vargas Centro de Investigación S.C.

location_facility: New York Presbyterian Columbia University Medical Center

location_facility: Municipal Nonprofit Institution of Lviv Regional Council "Lviv Regional Clinical Hospital"

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Joint Muscle Medical Care and Research Institute - Lilington Office

location_facility: Fondazione Policlinico Universitario A. Gemelli

location_facility: Federal State Budget Scientific Research Institution "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"

location_facility: Ternopil University Clinic - Rheumatology department

location_facility: Hospital Universitario Regional de Málaga

location_facility: Vinnytsya Regional Clinical Hospital - Rheumatology Department

location_facility: University Multiprofile Hospital for Active Treatment Pulmed

location_facility: Polyclinic of Private Security and Detectives

location_facility: University of the Philippines Manila - Philippine General Hospital

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

location_facility: Advanced Research Institute Inc Allergy & Rheumatology

location_facility: Municipal Nonprofit Institution "Vinnytsia City Clinical Hospital №1"

location_facility: Unidad de Investigaciones Reumatológicas A.C.

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Valerius Medical Group and Research Center

location_facility: Consultorio Privado de Especialidad del Dr. José Javier Orozco Alcalá

location_facility: Municipal Institution "Zaporizhzhya Regional Clinical Hospital"

location_facility: Centro de Investigación Clínica GRAMEL, S.C.

location_facility: UBAM Unidad Biomédica Avanzada Monterrey

location_facility: Paramount Medical Research and Consulting

location_facility: Clinic of State Institution "National Scientific Centre "Acad. Strazhesko Institute of Cardiology"

location_facility: Scientific and Research Institute of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU,

location_facility: Multiprofile Hospital For Active Treatment Trimontium

location_facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca

location_facility: City Clinical Hospital #15 named after O.M. Filatova

location_facility: University of Colorado School of Medicine

location_facility: Private Small Scale Medical Center "Pulse"

location_facility: Clinical Rheumatological Hospital Number 25

location_facility: Municipal Institution Kyiv Regional Council "Kyiv Regional Clinical Hospital"

location_facility: National Institute of Endocrinology - Prof. Elene Giorgadze Clinic

location_facility: Integral Rheumatology & Immunology Specialists

location_facility: North Georgia Rheumatology Group - Duluth

summary: The purpose of the study is to assess the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with systemic lupus erythematosus (SLE).


title: A Randomized, Multicenter, Phase Ib/III Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous Compared With Atezolizumab Intravenous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

summary: This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab IV in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part 2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields drug exposure that is comparable to that of atezolizumab IV.

ReferenceCitation: Felip E, Burotto M, Zvirbule Z, Herraez-Baranda LA, Chanu P, Kshirsagar S, Maiya V, Chan P, Pozzi E, Marchand M, Monchalin M, Tanaka K, Tosti N, Wang B, Restuccia E. Results of a Dose-Finding Phase 1b Study of Subcutaneous Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer. Clin Pharmacol Drug Dev. 2021 Oct;10(10):1142-1155. doi: 10.1002/cpdd.936. Epub 2021 Mar 31.

location_country:
Spain
Italy
United Kingdom
Ukraine
Costa Rica
Peru
South Africa
Poland
Russian Federation
Argentina
Turkey
Mexico
Brazil
Guatemala
Hungary
China
Bulgaria
Greece
Latvia
New Zealand
Thailand
Korea, Republic of
France
Chile

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: IRCCS Istituto Clinico Humanitas; Oncologia

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Medicine

location_facility: Ivano-Frankivsk Regional Oncology Center

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: Harbin Medical University Cancer Hospital

location_facility: General Hospital "G.Papanikolaou"; Pulmonogy Clinic

location_facility: Cancer Center of Guangzhou Medical University

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

location_facility: SBIH Kaluga Region Clinical Oncology Dispensary

location_facility: Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Onkologii Klinicznej

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: West China Hospital - Sichuan University

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Dept of Pulmonology & subdiv. of oncology

location_facility: James Lind Centro de Investigación Del Cáncer

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

location_facility: Samsung Medical Centre; Medical Oncology

location_facility: Murmansk Regional Clinical Hospital named after P.A. Bayandin

location_facility: Medipol University MF; Oncology Department

location_facility: Szpital Morski Im. Pck; Oncology & Radiotherapy Dept

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

location_facility: Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: UMHAT Dr Georgi Stranski; Medical Oncology Department

location_facility: Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Main Military Clinical Hospital named after N.N. Burdenko

location_facility: Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas

location_facility: Prince of Songkla University; Division of Pulmonary Disease, Department of Medicine

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Sir Run Run Shaw Hospital Zhejiang University

location_facility: Waikato Hospital - Cancer and Blood Research Trials Unit; Regional Cancer Centre

location_facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz

location_facility: Municipal Institution City Clinical Hospital #4 of Dnipro City Council

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: St James Hospital; Dept of Oncology/Hematology

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod

location_facility: Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept


acronym: VALOR-CKD

title: A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects With Metabolic Acidosis

lead_sponsor: Tricida, Inc.

ReferenceCitation: Hultin S, Johnson DW, Badve SV. Recent evidence on the effect of treatment of metabolic acid on the progression of kidney disease. Curr Opin Nephrol Hypertens. 2021 Sep 1;30(5):467-473. doi: 10.1097/MNH.0000000000000728. Review.

location_country:
Serbia
Spain
Armenia
Italy
United Kingdom
Ukraine
United States
Belgium
Romania
Czechia
Poland
Albania
Hong Kong
Portugal
Australia
Argentina
Israel
Mexico
Malaysia
Singapore
Slovakia
Brazil
Canada
Hungary
North Macedonia
Bulgaria
Taiwan
Belarus
Georgia
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility:
Investigative Site 2716
Investigative Site 3706
Investigative Site 1205
Investigative Site 4712
Investigative Site 4102
Investigative Site 2603
Investigative Site 4519
Investigative Site 4155
Investigative Site 2802
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Investigative Site 4602
Investigative Site 1502
Investigative Site 1210
Investigative Site 2501
Investigative Site 2715
Investigative Site 3902
Investigative Site 6512
Investigative Site 4305
Investigative Site 2309
Investigative Site 2107
Investigative Site 4516
Investigative Site 4203
Investigative Site 2714
Investigative Site 3407
Investigative Site 3103
Investigative Site 5215
Investigative Site 2106
Investigative Site 2511
Investigative Site 3716
Investigative Site 4104
Investigative Site 3801
Investigative Site 4106
Investigative Site 1208
Investigative Site 2604
Investigative Site 2310
Investigative Site 4208
Investigative Site 6511
Investigative Site 4405
Investigative Site 3402
Investigative Site 2212
Investigative Site 2514
Investigative Site 2805
Investigative Site 4509
Investigative Site 2306
Investigative Site 6401
Investigative Site 4409
Investigative Site 4108
Investigative Site 4146
Investigative Site 2209
Investigative Site 3905
Investigative Site 4307
Investigative Site 3603
Investigative Site 6506
Investigative Site 4709
Investigative Site 2214
Investigative Site 5218
Investigative Site 4316
Investigative Site 2706
Investigative Site 1213
Investigative Site 2202
Investigative Site 1203
Investigative Site 4708
Investigative Site 4123
Investigative Site 2705
Investigative Site 6105
Investigative Site 2213
Investigative Site 2316
Investigative Site 2505
Investigative Site 3108
Investigative Site 5208
Investigative Site 4408
Investigative Site 3815
Investigative Site 1412
Investigative Site 3507
Investigative Site 3505
Investigative Site 2312
Investigative Site 1305
Investigative Site 3605
Investigative Site 2204
Investigative Site 4324
Investigative Site 4508
Investigative Site 2718
Investigative Site 3607
Investigative Site 6210
Investigative Site 4310
Investigative Site 2311
Investigative Site 6203
Investigative Site 2713
Investigative Site 4157
Investigative Site 4204
Investigative Site 4124
Investigative Site 4302
Investigative Site 5101
Investigative Site 5207
Investigative Site 1211
Investigative Site 6503
Investigative Site 4319
Investigative Site 1303
Investigative Site 4141
Investigative Site 2211
Investigative Site 6502
Investigative Site 6206
Investigative Site 2807
Investigative Site 6205
Investigative Site 4116
Investigative Site 5204
Investigative Site 6510
Investigative Site 2712
Investigative Site 1212
Investigative Site 2710
Investigative Site 2721
Investigative Site 4517
Investigative Site 3405
Investigative Site 2809
Investigative Site 1201
Investigative Site 2210
Investigative Site 2421
Investigative Site 1103
Investigative Site 6104
Investigative Site 4130
Investigative Site 4325
Investigative Site 3503
Investigative Site 3408
Investigative Site 1302
Investigative Site 2207
Investigative Site 2704
Investigative Site 4201
Investigative Site 5212
Investigative Site 4127
Investigative Site 3205
Investigative Site 4507
Investigative Site 4504
Investigative Site 5205
Investigative Site 2803
Investigative Site 1101
Investigative Site 1304
Investigative site 2801
Investigative Site 4518
Investigative Site 3209
Investigative Site 6101
Investigative Site 2717
Investigative Site 6208
Investigative Site 2707
Investigative Site 6202
Investigative Site 4601
Investigative Site 3903
Investigative Site 6507
Investigative Site 3409
Investigative Site 4312
Investigative Site 2205
Investigative Site 6207
Investigative Site 2719
Investigative Site 4402
Investigative Site 4202
Investigative Site 2208
Investigative Site 4414
Investigative Site 2304
Investigative Site 6501
Investigative Site 4604
Investigative Site 2606
Investigative Site 3911
Investigative Site 2412
Investigative Site 3604
Investigative Site 4148
Investigative Site 6403
Investigative Site 4107
Investigative Site 4301
Investigative Site 3406
Investigative Site 4410
Investigative Site 5213
Investigative Site 5203
Investigative Site 4122
Investigative Site 4153
Investigative Site 2709
Investigative Site 1206
Investigative Site 3913
Investigative Site 4315
Investigative Site 3707
Investigative Site 2703
Investigative Site 1204
Investigative Site 4506
Investigative Site 4311
Investigative Site 4313
Investigative Site 3804
Investigative Site 4132
Investigative Site 1301
Investigative Site 2414
Investigative Site 6504
Investigative Site 2503
Investigative Site 6509
Investigative Site 6201
Investigative Site 4304
Investigative Site 2508
Investigative Site 6404
Investigative Site 4320
Investigative Site 4703
Investigative Site 2201
Investigative Site 6204
Investigative Site 6103
Investigative Site 4705
Investigative Site 2206

summary: The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.


title: A Physician-initiated, International, Multi-center, Prospective and Retrospective, Non Randomized, Observational Registry of Patients With Acute/Subacute Type B Aortic Dissection Treated by Means of the STABILISE Technique.

acronym: STABILISE

summary: The aim of the study is to evaluate results of patients treated with the STABILISE technique for acute/subacute aortic dissection. Results and postoperative events are reported in accordance with the current reporting standards for endovascular aortic repair prepared and revised by the Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery

time_perspective: Other

ReferenceType: background

ReferenceCitation: Fattori R, Cao P, De Rango P, Czerny M, Evangelista A, Nienaber C, Rousseau H, Schepens M. Interdisciplinary expert consensus document on management of type B aortic dissection. J Am Coll Cardiol. 2013 Apr 23;61(16):1661-78. doi: 10.1016/j.jacc.2012.11.072.

ReferenceCitation: Nienaber CA, Kische S, Zeller T, Rehders TC, Schneider H, Lorenzen B, Bünger C, Ince H. Provisional extension to induce complete attachment after stent-graft placement in type B aortic dissection: the PETTICOAT concept. J Endovasc Ther. 2006 Dec;13(6):738-46.

ReferenceCitation: Melissano G, Bertoglio L, Rinaldi E, Civilini E, Tshomba Y, Kahlberg A, Agricola E, Chiesa R. Volume changes in aortic true and false lumen after the "PETTICOAT" procedure for type B aortic dissection. J Vasc Surg. 2012 Mar;55(3):641-51. doi: 10.1016/j.jvs.2011.10.025. Epub 2012 Jan 28.

ReferenceCitation: Lombardi JV, Cambria RP, Nienaber CA, Chiesa R, Teebken O, Lee A, Mossop P, Bharadwaj P; STABLE investigators. Prospective multicenter clinical trial (STABLE) on the endovascular treatment of complicated type B aortic dissection using a composite device design. J Vasc Surg. 2012 Mar;55(3):629-640.e2. doi: 10.1016/j.jvs.2011.10.022. Epub 2011 Dec 9.

ReferenceCitation: Melissano G, Bertoglio L, Rinaldi E, Mascia D, Kahlberg A, Loschi D, De Luca M, Monaco F, Chiesa R. Satisfactory short-term outcomes of the STABILISE technique for type B aortic dissection. J Vasc Surg. 2018 Oct;68(4):966-975. doi: 10.1016/j.jvs.2018.01.029. Epub 2018 Mar 30.

ReferenceCitation: Hofferberth SC, Nixon IK, Boston RC, McLachlan CS, Mossop PJ. Stent-assisted balloon-induced intimal disruption and relamination in aortic dissection repair: the STABILISE concept. J Thorac Cardiovasc Surg. 2014 Apr;147(4):1240-5. doi: 10.1016/j.jtcvs.2013.03.036. Epub 2013 Apr 17.

ReferenceCitation: Fillinger MF, Greenberg RK, McKinsey JF, Chaikof EL; Society for Vascular Surgery Ad Hoc Committee on TEVAR Reporting Standards. Reporting standards for thoracic endovascular aortic repair (TEVAR). J Vasc Surg. 2010 Oct;52(4):1022-33, 1033.e15. doi: 10.1016/j.jvs.2010.07.008.

ReferenceCitation: Chaikof EL, Fillinger MF, Matsumura JS, Rutherford RB, White GH, Blankensteijn JD, Bernhard VM, Harris PL, Kent KC, May J, Veith FJ, Zarins CK. Identifying and grading factors that modify the outcome of endovascular aortic aneurysm repair. J Vasc Surg. 2002 May;35(5):1061-6. Review.

ReferenceCitation: Dake MD, Thompson M, van Sambeek M, Vermassen F, Morales JP; DEFINE Investigators. DISSECT: a new mnemonic-based approach to the categorization of aortic dissection. Eur J Vasc Endovasc Surg. 2013 Aug;46(2):175-90. doi: 10.1016/j.ejvs.2013.04.029. Epub 2013 May 28.

ReferenceCitation: Riambau V, Böckler D, Brunkwall J, Cao P, Chiesa R, Coppi G, Czerny M, Fraedrich G, Haulon S, Jacobs MJ, Lachat ML, Moll FL, Setacci C, Taylor PR, Thompson M, Trimarchi S, Verhagen HJ, Verhoeven EL, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfé N, Debus ES, Hinchliffe RJ, Kakkos S, Koncar I, Lindholt JS, Vega de Ceniga M, Vermassen F, Verzini F, Document Reviewers, Kolh P, Black JH 3rd, Busund R, Björck M, Dake M, Dick F, Eggebrecht H, Evangelista A, Grabenwöger M, Milner R, Naylor AR, Ricco JB, Rousseau H, Schmidli J. Editor's Choice - Management of Descending Thoracic Aorta Diseases: Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2017 Jan;53(1):4-52. doi: 10.1016/j.ejvs.2016.06.005.

lead_sponsor: IRCCS San Raffaele

location_country:
Brazil
Portugal
Spain
Italy
Austria
Australia
Netherlands
New Zealand
United Kingdom
Sweden
United States
France
Turkey
Germany

location_facility: Bristish Hospital XXI / Instituto Cardiovascular de Lisboa

location_facility: Royal Brompton & Harefield NHS Foundation

location_facility: London Guy's & St Thomas' NHS Foundation Trust

location_facility: University of Lund, General Hospital, Malmö

location_facility: University School of Medicine Department of Cardiovascular Surgery

location_facility: Columbia University Irving Medical Center


title: Effects of Plasma Exchange With Human Serum Albumin 5% (PE-A 5%) on Short-term Survival in Subjects With "Acute-On-Chronic Liver Failure" (ACLF) at High Risk of Hospital Mortality

acronym: APACHE

summary:
This is a Phase 3, multicenter, randomized, controlled, parallel-group, open-label study to evaluate the effects of plasma exchange using human serum albumin 5% (PE-A 5%) in acute-on-chronic liver failure (ACLF) subjects. The study will involve approximately 40 study centers in the United States, Canada, and Europe with expertise in the management of subjects with ACLF.

Subjects with ACLF at a high risk of hospital mortality will be enrolled. The study will consist of a Screening Period during which subjects will be randomized (1:1) to receive either standard medical treatment (SMT) + PE-A 5% (treatment group) or SMT only (control group), followed by a Treatment Period, and a Follow-up Period.

The Treatment Period for subjects in the SMT+ PE-A 5% treatment group will be between 7 and 17 days, depending on ACLF evolution.

The Treatment Period for subjects in the SMT control group will be a minimum of 7 days for all subjects and up to 17 days depending on the ACLF evolution. Subjects in this group will receive SMT according to the institution's standards.

The Follow-up Period for subjects in both groups will be 90 days.

lead_sponsor: Grifols Therapeutics LLC

location_country:
Denmark
Portugal
Spain
Italy
Austria
United Kingdom
United States
France
Belgium
Germany

location_facility: Centre Hépato-Biliaire - Hôpital Universitaire Paul Brousse

location_facility: University of Alabama at Birmingham (UAB) Hospital

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I

location_facility: Milano Hospital Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: King's College Hospital NHS Foundation Trust

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Ohio State University Wexner Medical Center

location_facility: Royal Free NHS Foundation Trust Hospital


title: A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Glepaglutide in Patients With Short Bowel Syndrome (SBS)

acronym: EASE SBS 1

summary:
The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome.

Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

lead_sponsor: Zealand Pharma

location_country:
Denmark
Poland
United Kingdom
Netherlands
Canada
United States
France
Belgium
Germany

location_facility: University of Chicago Children's Hospital

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: University Health Network - Toronto General Hospital

location_facility: Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi

location_facility: Vanderbilt University Medical Center, Nashville

location_facility: Universitätsklinikum Frankfurt - Med. Klinik I

location_facility: Szpital Skawina sp. z o.o. im. Stanley Dudricka


title: A Phase 3, Randomized, Double-Blind Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (KEEPsAKE 2)

summary: The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).

ReferenceType: result

ReferenceCitation: Östör A, Van den Bosch F, Papp K, Asnal C, Blanco R, Aelion J, Alperovich G, Lu W, Wang Z, Soliman AM, Eldred A, Barcomb L, Kivitz A. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Ann Rheum Dis. 2022 Mar;81(3):351-358. doi: 10.1136/annrheumdis-2021-221048. Epub 2021 Nov 23.

ReferenceCitation: Östör A, Van den Bosch F, Papp K, Asnal C, Blanco R, Aelion J, Lu W, Wang Z, Soliman AM, Eldred A, Padilla B, Kivitz A. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 2 study. Rheumatology (Oxford). 2022 Oct 25. pii: keac605. doi: 10.1093/rheumatology/keac605. [Epub ahead of print]

ReferenceCitation: Thakre N, D'Cunha R, Goebel A, Liu W, Pang Y, Suleiman AA. Population Pharmacokinetics and Exposure-Response Analyses for Risankizumab in Patients with Active Psoriatic Arthritis. Rheumatol Ther. 2022 Dec;9(6):1587-1603. doi: 10.1007/s40744-022-00495-0. Epub 2022 Sep 30.

ReferenceCitation: Ostor AJK, Soliman AM, Papp KA, Padilla B, Wang Z, Eldred A, de Vlam K, Kivitz A. Improved patient-reported outcomes in patients with psoriatic arthritis treated with risankizumab: analysis of the Phase 3 trial KEEPsAKE 2. RMD Open. 2022 Jun;8(2). pii: e002286. doi: 10.1136/rmdopen-2022-002286.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
South Africa
Poland
Portugal
Australia
Argentina
Puerto Rico
Israel
Singapore
Sweden
Brazil
Canada
Hungary
Germany
Denmark
Greece
Estonia
New Zealand
Finland
France
Netherlands

location_facility: Arthritis Clinical Research Trials /ID# 167611

location_facility: Inland Rheum Clin Trials Inc. /ID# 166621

location_facility: IRIS Research and Development, LLC /ID# 166351

location_facility: Rheumatology and Pulmonary Clinic /ID# 169341

location_facility: Amarillo Ctr for Clin Research /ID# 208340

location_facility: Malopolskie Centrum Kliniczne /ID# 208011

location_facility: Arthritis & Rheumatic Disease Specialties /ID# 212582

location_facility: Nashville Arthritis and Rheumatology /ID# 208395

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 207268

location_facility: Duplicate_Vastmanlands Sjukhus /ID# 168620

location_facility: Dartmouth-Hitchcock Medical Center /ID# 169443

location_facility: East Tallinn Central Hospital /ID# 208317

location_facility: Clinical Research Ctr Reading /ID# 166354

location_facility: CIP - Centro Internacional de Pesquisa /ID# 169524

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 169237

location_facility: Precision Comprehensive Clinical Research Solutions /ID# 208156

location_facility: Manchester University NHS Foundation Trust /ID# 207923

location_facility: New England Research Associates, LLC /ID# 166525

location_facility: Universitair Ziekenhuis Leuven /ID# 208209

location_facility: West Tennessee Research Institute /ID# 166429

location_facility: Orebro Universitetssjukhuset /ID# 169400

location_facility: Paramount Medical Research Con /ID# 166334

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 208541

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 208139

location_facility: Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 166681

location_facility: Duplicate_Karolinska Univ Sjukhuset /ID# 208174

location_facility: North Estonia Medical Centre /ID# 208319

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 206930

location_facility: Center of Innovative Diagnostics and Therapeutics (CIRI GmbH) /ID# 209494

location_facility: Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 211159

location_facility: Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 166658

location_facility: Rheumatology Clinic of Houston /ID# 166636

location_facility: Hospital General de Agudos J. M. Ramos Mejia /ID# 169152

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207822

location_facility: Rheumatic Disease Center, LLP /ID# 166682

location_facility: Bispebjerg and Frederiksberg Hospital /ID# 168763

location_facility: Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 169151

location_facility: MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 209493

location_facility: Winelands Medical Research Centre /ID# 167630

location_facility: Arthritis & Osteo Medical Ctr /ID# 166541

location_facility: CHRU Tours - Hopital Trousseau /ID# 209343

location_facility: Percuro Clinical Research, Ltd /ID# 169530

location_facility: Trinity Universal Research Associates, Inc /ID# 208387

location_facility: Universitair Medisch Centrum Groningen /ID# 168450

location_facility: Instituto Português De Reumatologia /ID# 208140

location_facility: Centrum Medyczne Reuma Park w Warszawie /ID# 210956

location_facility: Glacier View Research Institute /ID# 169344

location_facility: GCM Medical Group PSC - Hato Rey /ID# 208461

location_facility: Rheumatology Research Unit Sunshine Coast /ID# 207191

location_facility: Centro Medico Privado de Reumatologia /ID# 208342

location_facility: Hospital Universitario y Politecnico La Fe /ID# 207823

location_facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 208138

location_facility: West Texas Clinical Research /ID# 208155

location_facility: Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 209054

location_facility: Torbay and South Devon Nhs Foundation Trust /Id# 207926

location_facility: Duplicate_Barts Health NHS Trust /ID# 210794

location_facility: West Broward Rheumatology Associates /ID# 201234

location_facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 169248

location_facility: Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 166389

location_facility: Sweet Hope Research Specialty Inc /ID# 168163

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 208012

location_facility: East Bay Rheumatology Medical /ID# 166845

location_facility: Centre Rhumatologie de l'Est /ID# 208302

location_facility: Hospital Italiano de Buenos Aires /ID# 208473

location_facility: Duplicate_The Center for Rheumatology & Bone Research /ID# 166448

location_facility: Hospital Universitario 12 de Octubre /ID# 207820

location_facility: The Arthritis & Diabetes Clinic, Inc. /ID# 166707

location_facility: Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207800

location_facility: Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 207264

location_facility: Duplicate_Wirral University Teaching Hospital NHS Foundation Trust /ID# 210536

location_facility: Clinical Pharmacology Study Gr /ID# 166455

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 207819


acronym: ADAPT

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness

ReferenceCitation: Howard JF Jr, Bril V, Vu T, Karam C, Peric S, Margania T, Murai H, Bilinska M, Shakarishvili R, Smilowski M, Guglietta A, Ulrichts P, Vangeneugden T, Utsugisawa K, Verschuuren J, Mantegazza R; ADAPT Investigator Study Group. Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2021 Jul;20(7):526-536. doi: 10.1016/S1474-4422(21)00159-9. Erratum in: Lancet Neurol. 2021 Aug;20(8):e5.

location_country:
Denmark
Poland
Serbia
United Kingdom
Italy
Georgia
Netherlands
Russian Federation
Canada
Hungary
United States
France
Belgium
Japan
Germany
Czechia

location_facility:
Investigator Site 62
Investigator Site 27
Investigator Site 53
Investigator Site 33
Investigator Site 40
Investigator Site 20
Investigator Site 60
Investigator Site 15
Investigator Site 41
Investigator Site 30
Investigator Site 55
Investigator Site 54
Investigator Site 11
Investigator Site 65
Investigator Site 18
Investigator Site 7
Investigator Site 51
Investigator Site 28
Investigator Site 29
Investigator Site 25
Investigator Site
Investigator Site 59
Investigator Site 38
Investigator Site 19
Investigator Site 63
Investigator Site 12
Investigator Site 49
Investigator Site 43
Investigator Site 9
Investigator Site 48
Investigator Site 35
Investigator Site 39
Investigator Site 23
Investigator Site 2
Investigator Site 37
Investigator Site 34
Investigator Site 17
Investigator Site 8
Investigator Site 31
Investigator Site 50
Investigator Site 42
Investigator Site 66
Investigator Site 5
Investigator Site 32
Investigator Site 45
Investigator Site 47
Investigator Site 58
Investigator Site 24
Investigator Site 10
Investigator Site 3
Investigator Site 44
Investigator Site 16
Investigator Site 64
Investigator Site 4
Investigator Site 26
Investigator Site 13
Investigator Site 6
Investigator Site 36
Investigator Site 61
Investigator Site 56
Investigator Site 46
Investigator Site 57
Investigator Site 22
Investigator Site 21
Investigator Site 52
Investigator Site 14

summary: A randomized, double-blind, placebo controlled, multicenter Phase 3 trial to evaluate the efficacy, safety, tolerability, quality of life and impact on normal daily activities of ARGX-113 in patients with gMG.


title: Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy

summary:
The purpose of this study is to investigate the effects of nivolumab when given under the skin with or without rHuPH20.

This study will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy:

non-small cell lung cancer (NSCLC)
renal cell carcinoma (RCC)
unresectable or metastatic melanoma
hepatocellular carcinoma (HCC)
microsatellite instability-high or mismatch repair deficient colorectal cancer (MSI-H/dMMR CRC)
in Part B, other solid tumors may be considered at the discretion of the Clinical Trial Physician
In addition to the above tumors, Part E will also include participants with metastatic urothelial carcinoma (mUC).

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Brazil
Spain
Italy
United Kingdom
New Zealand
Argentina
United States
Chile
France
Mexico
Netherlands

location_facility: Willamette Valley Cancer Institute And Research Center

location_facility: Texas Oncology - Baylor Charles A. Simmons Cancer Center