title: A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus)

acronym: ADDRESS

summary: This is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to investigate the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK, and PD of efgartigimod PH20 SC in adult participants aged from 18 years with PV or PF. The trial comprises a screening period of up to 3 weeks, a treatment period of up to 30 weeks, and an 8-week follow-up period for participants who do not enroll into the open-label extension (OLE) trial ARGX-113-1905. The primary objective of the ARGX-113-1904 trial is to demonstrate the efficacy of subcutaneous administration of efgartigimod co-formulated with recombinant human hyaluronidase PH20 (Efgartigimod PH20 SC) compared to placebo in the treatment of participants with Pemphigus Vulgaris (PV). Secondary objectives are to also demonstrate the efficacy of efgartigimod PH20 SC in the treatment of participants with Pemphigus Foliaceus (PF), and to demonstrate early onset of action and a prednisone-sparing effect. After confirmation of eligibility, participants will be randomized in a 2: 1 ratio to receive efgartigimod PH20 SC or placebo

lead_sponsor: argenx

location_country:
Italy
India
Spain
Germany
France
Bulgaria
Greece
Israel
Georgia
Japan
Hungary
Australia
Poland
Romania
Russian Federation
Turkey
United States
United Kingdom
Ukraine

location_facility:
Investigator site 51 - GR0300006
Investigator site 57 - RU0070029
Investigator site 50 - GR0300002
Investigator site 48 - DE0490030
Investigator site 13 - BG3590011
Investigator site 107 - RO0400015
Investigator site 76 - TR0900020
Investigator site 67 - ES0340034
Investigator site 56 - RU0070031
Investigator site 93 - JP0810041
Investigator site 94 - JP0810046
Investigator site 21 - DE0490026
Investigator site 35 - GE9950013
Investigator site 42 - HU0360002
Investigator site 85 - JP0810050
Investigator site 83 - JP0810043
Investigator site 6 - ES0340027
Investigator site 39 - GR0300003
Investigator site 73 - US00100
Investigator site 75 - TR0900012
Investigator site 19 - US0010088
Investigator site 59 - US0010106
Investigator site 47 - DE0490023
Investigator site 10 - ES0340025
Investigator site 4 - BG3590010
Investigator site 80 - IN0910002
Investigator site 9 - US0010099
Investigator site 84 - JP0810047
Investigator site 46 - FR0330029
Investigator site 43 - IT390005
Investigator site 44 - US0010101
Investigator site 41 - GR0300005
Investigator site 97 - US0010091
Investigator site 37 - DE0490002
Investigator site 78 - US0010109
Investigator site 77 - US0010086
Investigator site 25 - DE0490025
Investigator site 54 - RU0070035
Invetistigator site 8 - ES0340029
Investigator site 95 - PL0480036
Investigator site 14 - HU0360001
Investigator site 87 - TR0900011
Investigator site 22 - HU0360003
Investigator site 52 - IT0390031
Investigator site 53 - RU0070032
Investigator site 60 - US0010096
Investigator site 34 - FR0330028
Investigator site 105 - RO0400014
Investigator site 33 - FR0330027
Investigator site 89 - UA3800017
Investigator site 5 - AU0610007
Investigator site 70 - IT0390038
Investigator site 23 - ES0340031
Investigator site 88 - US0010114
Investigator site 2 - US0010087
Investigator site 24 - AU0610006
Investigator site 71 - IT0390040
Investigator site 74 - JP0810045
Investigator site 102 - US0010098
Investigator site 40 - GR0300004
Investigator site 68 - DE0490001
Investigator site 106 - RO0400013
Investigator site 38 - DE0490028
Investigator site 18 - UA3800019
Investigator site 96 - UK0440022
Investigator site 98 - US0010107
Investigator site 15 - ES0340032
Investigator site 12 - ISR9720002
Investigator site 55 - RU0070030
Investigator site 20 - US0010094
Investigator site 90 - IN0910004
Investigator site 69 - GR0300001
Investigator site 79 - DE0490027
Investigator site 91 - IN0910003
Investigator site 7 - ES0340028
Investigator site 30 - BG350012
Investigator site 64 - DE0490029
Investigator site 26 - PL0480027
Investigator site 1 - US0010084
Investigator site 104 - IT0390039
Investigator site 92 - IT0390030
Investigator site 29 - ES0340026
Investigator site 100 - IN0910001
Investigator site 16 - UA3800020
Investigator site 58 - RU0070033
Investigator site 72 - PL0480032
Investigator site 62 - UA3800021
Investigator site 17 - UA3800018
Investigator site 45 - UA3800023
Investigator site 61 - US0010090
Investigator site 32 - FR0330026
Investigator site 101 - US0010097
Investigator site 82 - JP0810042
Investigator site 27 - PL0480025
Investigator site 36 - GE9950015
Investigator site 28 - PL0480028
Investigator site 11 - IT0390006
Investigator site 66 - RU0070028
Investigator site 81 - JP0810040
Investigator site 103 - AU0610013
Investigator site 63 - GE9950014
Investigator site 99 - US0010117
Investigator site 65 - RU0070034
Investigator site 49 - DE0490024
Investigator site 31 - BG3590013
Investigator site 86 - JP0810049


title: EPIK-P2: A Phase II Double-blind Study With an Upfront, 16-week Randomized, Placebo-controlled Period, to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)

summary: This is a prospective Phase II multi-center study with an upfront 16-week, randomized, double-blind, placebo-controlled period, and extension periods, to assess the efficacy, safety and pharmacokinetics of alpelisib in pediatric and adult participants with PIK3CA-related overgrowth spectrum (PROS).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Novartis Pharmaceuticals

location_country:
United States
Switzerland
Netherlands
France
Norway
Spain
Germany
Canada

location_facility:
UCLA Medical Center
Childrens Healthcare of Atlanta
Washington University
Childrens Hospital Colorado
Novartis Investigative Site
UNC Chapel Hill

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)

summary: This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.

ipd_sharing: Undecided

lead_sponsor: Mitsubishi Tanabe Pharma Development America, Inc.

location_country:
Italy
United States
France
Japan
Germany
Canada

location_facility: National Hospital Organization Hokkaido Medical Center

location_facility: National Hospital Organization Toneyama Medical Center

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Tokyo Metropolitan Neurological Hospital

location_facility: Hopital Pierre Wertheimer - Hopital Neurologique

location_facility: Shiga University of Medical Science Hospital

location_facility: National Hospital Organization Iou National Hospital

location_facility: Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)

location_facility: Niigata University Medical And Dental Hospital

location_facility: Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

location_facility: University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)

location_facility: Montreal Neurological Institute and Hospital

location_facility: National Hospital Organization Kumamoto Saishun Medical Center

location_facility: Lewis Katz School of Medicine at Temple University

location_facility: Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)

location_facility: Johns Hopkins University School of Medicine

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux

location_facility: National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

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

location_facility: Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation

location_facility: National Hospital Organization Chibahigashi National Hospital

location_facility: Kansai Electric Power Hospital Recruiting

location_facility: Heritage Medical Research Clinic - University Of Calgary


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal Function

acronym: ALIGN

summary: The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal function.

ipd_sharing: No

lead_sponsor: Chinook Therapeutics U.S., Inc.

location_country:
Italy
Brazil
United States
Hong Kong
Germany
France
Japan
Poland
Australia
New Zealand
Spain
Canada
Korea, Republic of
Taiwan

location_facility: Pelican Point Dialysis - DaVita Clinical Research

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Kokura Memorial Hospital (Kokura Kinen Hospital)

location_facility: National Taiwan University Hospital Hsin-Chu Branch

location_facility: Seoul National University Bundang Hospital

location_facility: CHU de Grenoble - Hopital Albert Michallon

location_facility: Dokkyo Medical University - Saitama Medical Center

location_facility: Kyung Hee University Hospital at Gangdong

location_facility: Mountain Kidney and Hypertension Associates

location_facility: Brookview Hills Research Associates, LLC

location_facility: San Antonio Kidney Disease Center Physicians Group, P.L.L.C

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital das Clinicas da Faculdade de Medicina da USP

location_facility: St. Marianna University (SMU) School of Medicine

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Nephrology Associates Of Northern Virginia


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.

study_start_date_type: Anticipated

status: Not yet recruiting

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ipd_sharing: Yes

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:
Italy
United States
Switzerland
Netherlands
Germany
Finland
France
Belgium
Argentina
Canada
United Kingdom

location_facility: University College London and University College London Hospital

location_facility: University Hospital Heidelberg andGerman Cancer Research Center

location_facility: Hampshire Hospitals NHS Foundation Trust

location_facility: Weill Cornell Medicine New York-Presbyterian Hospital

location_facility: Hospices Civils de Lyon of the Hôpital Edouard Herriot

location_facility: Hospices Civils de Lyon, Centre Hospitalier Lyon Sud

location_facility: MRC Oulu, University of Oulu and Oulu University Hospital

intervention_type: Diagnostic Test

lead_sponsor_type: academique


status: Active, not recruiting

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/members/ourmembers/). 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

enrollment_type: Actual

location_country:
Italy
United States
Switzerland
Netherlands
France
Poland
Belgium
Germany
United Kingdom

acronym: Jewelfish

location_facility: Hôpital Necker-Enfants Malades; Service de neuropédiatrie

location_facility: IRCCS Ospedale Pediatrico Bambino Gesù; U.O. Malattie Neuromuscolari e Neurodegenerative

location_facility: UCL Institute of Child Health & Great Ormond Street Hospital for Children

location_facility: Azienda Ospedaliera Universitaria Policlinico G.Martino; Dip. Neurologia e Malattie neuromuscolari

location_facility: Universitätsklinikum Essen; Klinik für Kinderheilkunde I

location_facility: Columbia University Medical Center; The Neurological Institute of New York

location_facility: Hopital des Enfants; Unite de Neurologie Pediatrique

location_facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

location_facility: Hopital Femme Mere Enfant; Medecine Physique et Readaptation Pediatrique - L'ESCALE

location_facility: CHRU de Montpellier, Hopital Gui de Chauliac; Service de Neuropediatrie

location_facility: Universitätsklinikum Freiburg; Klinik für Neuropädiatrie und Muskelerkrankungen

location_facility: UMC Utrecht; Polkliniek Neuromusculaire ziekten

location_facility: Policlinico Agostino Gemelli; Dipartimento di Neuropsichiatria Infantile

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; Unità Operativa Complessa di Neurologia

location_facility: IRCCS Istituto Giannina Gaslini; U.O.S.D. Centro di Miologia e Patologie Neurodegenerative

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

source: euctr

title: An Open-Label Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Risdiplam (RO7034067) in Adult and Pediatric Patients With Spinal Muscular Atrophy

summary: This is a multi-center, exploratory, non-comparative, and open-label study to investigate the safety, tolerability, PK, and PK/PD relationship of risdiplam in adults, children and infants with Spinal Muscular Atrophy (SMA) previously enrolled in Study BP29420 (Moonfish) with the splicing modifier RO6885247 or previously treated with nusinersen, olesoxime or AVXS-101.


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).

location_country:
Peru
Greece
Belgium
Australia
Russian Federation
Denmark
Ukraine
France
Poland
Argentina
Canada
Switzerland
Hungary
Portugal
Germany
United Kingdom
United States
Italy
Brazil
Spain
Turkey

location_facility: Dr. HIBBEY Egeszsegugyi es Szolgaltato Kft

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: AOU Seconda Università degli Studi; Dip. Assistenziale Integrato Medicina Int-II Clinica Neurologica

location_facility: Clinica Neurologica; Neurocirurgica de Joinville

location_facility: SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM;Oddzial Kliniczny Neurologii

location_facility: St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU; Dept. of Neuroinfection and Multiply Sclerosis

location_facility: Universita' G. D'Annunzio; Dipartimento di Neuroscienze, Imaging e Scienze Cliniche

location_facility: Federal center of brain research and neurotechnologies

location_facility: Hospital de Santa Maria; Servico de Neurologia

location_facility: Universität Leipzig; Innere Medizin, Neurologie, Dermatologie

location_facility: Hospital Alvaro Cunqueiro; Servicio de Neurologia

location_facility: The NeuroMedical Clinic of Central Louisiana

location_facility: Hospital Puerta del Mar; Sevicio de Neurologia

location_facility: CHU Hopital Gabriel Montpied; Service de Neurologie

location_facility: Policlinico Umberto I; Centro Sclerosi Multipla DAI Neuroscienze e Salute Mentale

location_facility: St. Josef-Hospital, Klinik für Neurologie

location_facility: Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON

location_facility: Mountain Neurological Research Center; Roaring Fork Neurologt, P.C.

location_facility: AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica

location_facility: Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council

location_facility: Rigshospitalet Glostrup; Neurologisk Klinik

location_facility: Universitätsklinikum Tübingen, Zentrum für Neurologie

location_facility: Ospedale Regionale di Lugano - Civico; Neurologia

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: Medical Center of Private Execution First Private Clinic

location_facility: Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)

location_facility: Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY

location_facility: Cleveland Clinic Lou Ruvo; Center for Brain Research

location_facility: Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddział Neurologiczny

location_facility: University of California Davis Medical Center

location_facility: City Clinical Hospital #24; Multipal Sclerosis department

location_facility: Hôpital Charles Nicolle; Service de Neurologie

location_facility: Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Badań Klinicznych

location_facility: Inselspital Bern Medizin Neurologie; Neurologische Poliklinik

location_facility: Kocaeli University Hospital; Department of Neurology

location_facility: Washington University School of Medicine

location_facility: Zaporizhia City Multispecialty Clinical Hospital #9

location_facility: Universitätsklinikum Schleswig-Holstein; Klinik für Neurologie

location_facility: State Autonomous Healthcare Institution "Republican Clinical Neurological Center

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia

location_facility: Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Oklahoma Medical Research Foundation; MS Center of Excellence

location_facility: Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

location_facility: Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik

location_facility: MS and Neuromuscular Center of Excellence

location_facility: Mun.Med.Proph.Inst."Chernihiv Reg.Hosp."; Neurology Department

location_facility: Hospital Regional Universitario de Malaga - Hospital General; Servicio de Neurologia

location_facility: AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.

location_facility: Regional Clinical Hospital; Neurology Department

location_facility: Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage

location_facility: Saratov State Medical University of RosZdrav; Neurology

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council

location_facility: National Center of Social Significant Disease

location_facility: FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

location_facility: Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo; Peru

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz; Department of Neurology

location_facility: Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

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

location_facility: Neurology Associates, PA; Research Department

location_facility: Austin Hospital; Department of Neurology

location_facility: Stanford University Medical Center; Stanford Neuroscience Health Center

location_facility: Clinica Internacional; Unidad De Investigacion

location_facility: SHI Sverdlovsk Regional Clinical Hospital #1;Neurology

location_facility: Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia

location_facility: IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla

location_facility: Hospital Vall de Hebrón; Servicio de Neurologia. Centre d'Esclerosi Multiple de Catalunya CEMCAT

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: 401 Military Hospital of Athens; Neurology Department

location_facility: KSMU Interregional Clinical Diagnostic Centre

location_facility: Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz; Neurologia

location_facility: City Hospital #40 of Kurortniy Administrative District

location_facility: N.P. Bechtereva Institute of the Human Brain

title: A Phase IIIb Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis

summary: This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with RMS, in comparison to the approved 600 mg dose of ocrelizumab.


title: A Phase 1/2, Open-label, Multicenter Study of the Combination of NKTR-214 and Nivolumab or the Combination of NKTR-214, Nivolumab, and Other Anti-Cancer Therapies in Patients With Select Locally Advanced or Metastatic Solid Tumor Malignancies

summary: In this four-part study, NKTR-214 will be administered in combination with nivolumab in Part 1, in combination with nivolumab with or without various chemotherapies in Part 2, and with nivolumab and ipilimumab in Parts 3 & 4. In Part 1, the Recommended Phase 2 Dose (RP2D) of NKTR-214 in combination with nivolumab will be determined. In Part 2, NKTR-214 with nivolumab at the RP2D will be evaluated as first-line therapy and/or as second or third line therapy in select patients with Melanoma, Renal Cell Carcinoma (RCC), Non-Small Cell Lung Cancer (NSCLC), Urothelial Carcinoma (UC), metastatic Breast Cancer (mBC) and Colorectal Cancer (CRC). In addition, in Part 2, the RP2D of NKTR-214 with nivolumab and various chemotherapies and regimens in select cohorts of NSCLC patients will be determined. In Part 3, several different regimens of the triplet combination of NKTR-214 plus nivolumab and ipilimumab will be evaluated in select patients with RCC, NSCLC, Melanoma, and UC. In Part 4, the safety and efficacy of the triplet combination will be evaluated further in select patients with RCC, NSCLC, Melanoma and UC.

ReferenceType: derived

ReferenceCitation: Diab A, Tykodi SS, Daniels GA, Maio M, Curti BD, Lewis KD, Jang S, Kalinka E, Puzanov I, Spira AI, Cho DC, Guan S, Puente E, Nguyen T, Hoch U, Currie SL, Lin W, Tagliaferri MA, Zalevsky J, Sznol M, Hurwitz ME. Bempegaldesleukin Plus Nivolumab in First-Line Metastatic Melanoma. J Clin Oncol. 2021 Sep 10;39(26):2914-2925. doi: 10.1200/JCO.21.00675. Epub 2021 Jul 13.

name: The University of Texas MD Anderson Cancer Center, Houston, TX

family: Diab

full_name: Adi Diab

given: Adi

sequence: first

name: University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA

family: Tykodi

full_name: Scott S. Tykodi

given: Scott S.

sequence: additional

name: University of California, La Jolla, San Diego, CA

family: Daniels

full_name: Gregory A. Daniels

given: Gregory A.

name: Azienda Ospedaliera Universitaria Senese, Siena, Italy

family: Maio

full_name: Michele Maio

given: Michele

name: Providence Cancer Institute and Earle A. Chiles Research Institute, Portland, OR

family: Curti

full_name: Brendan D. Curti

given: Brendan D.

name: University of Colorado Cancer Center, Aurora, CO

family: Lewis

full_name: Karl D. Lewis

given: Karl D.

name: Inova Schar Cancer Institute, Fairfax, VA

family: Jang

full_name: Sekwon Jang

given: Sekwon

name: Polish Mother's Memorial Hospital—Research Institute, Lodz, Poland

family: Kalinka

full_name: Ewa Kalinka

given: Ewa

name: Roswell Park Comprehensive Cancer Center, Buffalo, NY

family: Puzanov

full_name: Igor Puzanov

given: Igor

name: Virginia Cancer Specialists, Fairfax, VA

family: Spira

full_name: Alexander I. Spira

given: Alexander I.

name: Perlmutter Cancer Center at NYU Langone Medical Center, New York, NY

family: Cho

full_name: Daniel C. Cho

given: Daniel C.

family: Guan

full_name: Shanhong Guan

given: Shanhong

family: Puente

full_name: Erika Puente

given: Erika

family: Nguyen

full_name: Tuan Nguyen

given: Tuan

family: Hoch

full_name: Ute Hoch

given: Ute

family: Currie

full_name: Sue L. Currie

given: Sue L.

family: Lin

full_name: Wei Lin

given: Wei

family: Tagliaferri

full_name: Mary A. Tagliaferri

given: Mary A.

family: Zalevsky

full_name: Jonathan Zalevsky

given: Jonathan

family: Sznol

full_name: Mario Sznol

given: Mario

family: Hurwitz

full_name: Michael E. Hurwitz

given: Michael E.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Clinical Oncology

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Veatch JR, Singhi N, Jesernig B, Paulson KG, Zalevsky J, Iaccucci E, Tykodi SS, Riddell SR. Mobilization of pre-existing polyclonal T cells specific to neoantigens but not self-antigens during treatment of a patient with melanoma with bempegaldesleukin and nivolumab. J Immunother Cancer. 2020 Dec;8(2). pii: e001591. doi: 10.1136/jitc-2020-001591. Erratum in: J Immunother Cancer. 2021 Feb;9(2):.

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

location_facility: Washington University School of Medicine in St. Louis

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Centro Integral Oncológico Clara Campal (CIOCC)

location_facility: Assistance Publique Hopitaux de Marseille - Hopital Nord

location_facility: Azienda Ospedaliera San Camillo-Forlanini

location_facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

location_facility: Instytut Medyczny Santa Familia Sp. z o. o. w Łodzi

location_facility: Loyola University Medical Center, Chicago

location_facility: Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy

location_facility: Indiana University Health Melvin & Bren Simon Cancer Center

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii

location_facility: Institute for Cancer Research and Treatment (IRCC)

location_facility: Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS)

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: New York University Langone Medical Center - NYU Cancer Institute


intervention_type: Biological

status: Completed

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

primary_purpose: Prevention

location_country:
Italy
United States
Netherlands
France
Russian Federation
Spain
Turkey
Germany
Canada

acronym: rVWF IN PROPHYLAXIS

location_facility: Comprehensive Cancer Center of Wake Forest Unversity

location_facility: Bleeding and Clotting Disorders Institute

location_facility: Groupement Hospitalier Est- Hôpital Louis Pradel

location_facility: SBEI HPE Altai State Medical University of MoH and SD

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: University of Florida College of Medicine

location_facility: FSBI of Science "Kirov Scientific and Research Institute of Hematology and Blood Transfusion of FMBA

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

location_facility: Hospital General Universitario de Alicante

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: SAIH "Kemerovo Regional Clinical Hospital"

study_completion_date_type: Actual

title: A PROSPECTIVE, PHASE 3, OPEN-LABEL, INTERNATIONAL MULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXIS WITH rVWF IN SEVERE VON WILLEBRAND DISEASE

summary: The purpose of this phase 3 study is to investigate the efficacy and safety, including immunogenicity, thrombogenicity and hypersensitivity reactions, as well as pharmacokinetics (PK), health related quality of life (HRQoL) and pharmacoeconomics of prophylactic treatment with recombinant von Willebrand factor (rVWF) (vonicog alfa) in adult participants with severe von Willebrand disease (VWD).

status_simplified: Completed


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])

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

lead_sponsor: ViiV Healthcare

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


title: An Open-label, Multi-center Long-term Safety Roll-over Study in Patients With Tuberous Sclerosis Complex (TSC) and Refractory Seizures Who Are Judged by the Investigator to Benefit From Continued Treatment With Everolimus After Completion of Study CRAD001M2304.

summary: The purpose of this study is to evaluate the long-term safety in patients with TSC and refractory seizures who are currently receiving everolimus treatment in the Novartis-sponsored EXIST-3 study and who are determined to be benefiting from continued treatment as judged by the investigator at the completion of EXIST-3

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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:
Italy
United States
Mexico
France
Japan
Poland
Thailand
Hungary
Belgium
Australia
Russian Federation
Spain
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan
Colombia

location_facility: Cincinnati Children s Hospital Medical Center SC-2

location_facility: University of Colorado School of Medicine

location_facility: Texas Scottish Rite Hospital for Children SC


title: Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders, Previously Untreatable and High Risk Upgrade Patients (SOLVE CRT)

acronym: SOLVE-CRT

summary: This study is a prospective, multi-center, pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy.

ReferenceCitation: Singh JP, Abraham WT, Auricchio A, Delnoy PP, Gold M, Reddy VY, Sanders P, Lindenfeld J, Rinaldi CA. Design and rationale for the Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in non-responders and previously untreatable patients (SOLVE-CRT) trial. Am Heart J. 2019 Nov;217:13-22. doi: 10.1016/j.ahj.2019.04.002. Epub 2019 Apr 9.

family: Singh

full_name: Jagmeet P. Singh

given: Jagmeet P.

family: Abraham

full_name: William T. Abraham

given: William T.

family: Auricchio

full_name: Angelo Auricchio

given: Angelo

family: Delnoy

full_name: Peter Paul Delnoy

given: Peter Paul

family: Gold

full_name: Michael Gold

given: Michael

family: Reddy

full_name: Vivek Y. Reddy

given: Vivek Y.

family: Sanders

full_name: Prashanthan Sanders

given: Prashanthan

family: Lindenfeld

full_name: JoAnn Lindenfeld

given: JoAnn

family: Rinaldi

full_name: Christopher A Rinaldi

given: Christopher A

journal_name: American Heart Journal

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: EBR Systems, Inc.

location_country:
Italy
United States
Netherlands
France
Australia
Germany
United Kingdom

location_facility: The University of Texas Health Science Center at Houston

location_facility: CHU Grenoble - Hopital Michallon Service de Cardiologie

location_facility: Universitäres Herzzentrum Hamburg (UKE Hamburg) GmbH (UHZ)

location_facility: St. Vincent's Hospital and Healthcare Center

location_facility: Methodist Physicians Heart Clinic Consultants

location_facility: Clinique Pasteur Cardiologie & Rythmologie

location_facility: Immanuel Klinikum Bernau - Herzzentrum Brandenburg

intervention_type: Device


title: A Phase II Single Arm Clinical Trial of a Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Renal Cell Carcinoma

acronym: TITAN-RCC

summary: TITAN RCC (0216-ASG) is a Phase 2, open-label study of nivolumab monotherapy with additional nivolumab/ipilimumab "boost" cycles in previously untreated and pretreated (2nd line), advanced or metastatic renal cell carcinoma (mRCC) subjects with intermediate and high risk disease according to IMDC.

lead_sponsor: AIO-Studien-gGmbH

location_country:
Italy
Austria
France
Czechia
Belgium
Spain
Germany
United Kingdom

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Universität des Saarlandes Medizinische Fakultät

location_facility: Ordensklinikum Linz Barmherzige Schwestern

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Hôpitaux Universitaires de Strasbourg Hôpital Civil

location_facility: AKH Wien Universitätsklinik für Innere Medizin I

location_facility: Hospital Universitario Central de Asturias

location_facility: Universitätsklinikum Jena und Poliklinik für Urologie

location_facility: Azienda USL8 Arezzo U.O.C. Oncologia Medica


location_country:
Italy
Brazil
United States
Serbia
Spain
Germany
Croatia
France
Japan
Poland
Belgium
Russian Federation
China
Turkey
Canada
United Kingdom

acronym: SUNFISH

location_facility: Fondazione IRCCS Istituto Neurologico "Carlo Besta"; UO di Neurologia dello Sviluppo

location_facility: University of Oxford; Department of Paediatrics

location_facility: Hôpital Necker-Enfants Malades; Service de neuropédiatrie

location_facility: IRCCS Ospedale Pediatrico Bambino Gesù; U.O. Malattie Neuromuscolari e Neurodegenerative

location_facility: Clinic for Neurology and Psychiatry for Children and Youth

location_facility: London Health Sciences Centre; Children's Hospital; Pediatrics

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Reumatologia

location_facility: Columbia University Medical Center; The Neurological Institute of New York

location_facility: Hospital Yeditepe University Kozyatagi; Pediatry

location_facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

location_facility: Hospital Universitario Virgen del Rocío; Servicio de Neuropediatra

location_facility: Instituto de Puericultura E Pediatria Martagão Gesteira

location_facility: Hacettepe University, School of Medicine; Pediatrics Department; Pediatrics Child Neurology Unit

location_facility: Hopital Femme Mere Enfant; Medecine Physique et Readaptation Pediatrique - L'ESCALE

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

location_facility: Universitätsklinikum Freiburg; Klinik für Neuropädiatrie und Muskelerkrankungen

location_facility: McGill University Health Centre - Glen Site

location_facility: Szpital Kliniczny im. H. Swiecickiego U.M. w Poznaniu; Od. Kliniczny Neurologii Dzieci i Młodziezy

location_facility: Policlinico Agostino Gemelli; Dipartimento di Neuropsichiatria Infantile

location_facility: Alberta Children's Hospital Division of Pediatric Neurology

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; Unità Operativa Complessa di Neurologia

location_facility: IRCCS Istituto Giannina Gaslini; U.O.S.D. Centro di Miologia e Patologie Neurodegenerative

location_facility: Szpital Gdanskiego Uniwersytetu Medycznego; Clinic of developmental neurology

location_facility: National Center Of Neurology And Psychiatry Hospital

location_facility: Russian Children Neuromuscular Center of Veltischev

location_facility: Clinical Medical Center Zagreb; University Hospital Rebro Department of Paediatrics

title: A Two Part Seamless, Multi-Center Randomized, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy Patients

summary: Multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of Risdiplam in adult and pediatric participants with Type 2 and Type 3 SMA. The study consists of two parts, an exploratory dose finding part (Part 1) of Risdiplam for 12 weeks and a confirmatory part (Part 2) of Risdiplam for 24 months.


type: Other Identifier

title: GLOBAL PREVALENCE OF TRANSTHYRETIN AMYLOID CARDIOMYOPATHY (ATTR-CM) IN PARTICIPANTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFpEF)

summary: This study is a global, multi-center study designed to estimate the global prevalence of transthyretin amyloid cardiomyopathy (ATTR-CM) within a clinically at risk population [participants with heart failure with preserved ejection fraction (HFpEF)].

primary_purpose: Screening

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.

lead_sponsor: Pfizer

location_country:
Italy
France
Japan
Spain
United States

location_facility: Providence Sacred Heart Medical Center and Children's Hospital

location_facility: Fondazione Toscana Gabriele Monasterio-UOC Cardiologia e Medicina Cardiovascolare

location_facility: Cardiology Associates of North Mississippi, LLC

location_facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

location_facility: U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS

location_facility: Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Centre Hospitalier Saint-Joseph Saint-Luc


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.

lead_sponsor: Bayer

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

acronym: PULSAR

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

location_facility: Szent-Gyorgyi Albert Orvostudomanyi Egyetem

location_facility: Hospital of LT University of Health Sciences Kaunas Clinics

location_facility: Kaiser Permanente Riverside Medical Center

location_facility: Japanese Red Cross Wakayama Medical center

location_facility: The First Affiliated Hospital of Xinjiang Medical University

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

location_facility: Kansai Medical University Medical Center

location_facility: Northern California Retina-Vitreous Associates

location_facility: OFTALMOS, Instituto Oftalmologico de Alta Complejidad

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

location_facility: Tianjin Medical University General Hospital

location_facility: Instituto Oftalmológico Francisco Gomez Ulla

location_facility: Centre d'Ophtalmologie - Paradis-Monticelli

location_facility: Retina Consultants of Southern California

location_facility: Riga East Clinical University Hospital "Gailezers"

location_facility: Arizona Retina and Vitreous Consultants - Research

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: Ophthalmology Clinic of Professor Sergienko

location_facility: Signes Ozolinas Doctor Praxis in Ophthalmology

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

location_facility: Retina Consultants of Southern Colorado, PC

location_facility: Shanghai Tongji Hospital of Tongji University

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

location_facility: Retina Vitreous Associates of Florida - Saint Petersburg

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

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Scientific Research Institution of Ophthalmic Diseases

location_facility: Hadassah Hebrew University Hospital Ein Kerem

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

location_facility: Vilnius University Hospital Santaros Klinikos

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

location_facility: Multiprofile Hospital for Active Treatment Sveta Sofia

location_facility: Hospital General Universitario de Valencia

location_facility: Irkutsk Branch of FBSI IRTC "Eye Microsurgery"

location_facility: Kharkiv Ophthalmological Clinic #14 named by Hirshman

location_facility: Seoul National University Bundang Hospital

location_facility: Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Private enterprise private production company " Acinus"

location_facility: Ophthalmic Consultants of the Capital Region

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: St. Petersburg Medical University n.a. I.P. Pavlov

location_facility: Henan Provincial Ophthalmology Hospital (Henan Eye Institute

location_facility: ALM Oftalmolaser - Oftalmologia Medica e Cirurgica

location_facility: Peking Union Medical College Hospital CAMS

location_facility: Organizacion Medica de Investigacion (OMI)

location_facility: The Second Hospital of Anhui medical university

location_facility: The 1st Affiliated Hospital of Zhejiang University

location_facility: LTD Israeli-Georgian Medical Research Clinic "Helsicore"

location_facility: The Affiliated Eye Hospital of Wenzhou Medical College

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

location_facility: Regional Ophthalmological Hospital n. a. T.I. Eroshevsky

location_facility: Health Technology Ltd. - Ophthalmic Medical Center

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: Hospital Universitari i Politècnic La Fe

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

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: St. Marianna University School of Medicine Hospital

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

location_facility: The First Affiliated Hospital of NanChang University

location_facility: The 1st Affiliated Hospital Fujian Medical University

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

location_facility: Tokyo Women's Medical University Hospital

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

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

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.


title: The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)

acronym: STEM

summary: STEM Study is a pivotal, international, multi-center, prospective, randomized (1:1) controlled trial designed to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural Hematoma (cSDH)

lead_sponsor: Balt USA

location_country:
Germany
United States
France
Spain

location_facility: Penn State Health Hershey Medical Center

intervention_type: Other


title: A Phase Ib, Open-Label, Multicenter Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer.

summary: A study evaluating the safety, preliminary efficacy and pharmacokinetics of ipatasertib in combination with atezolizumab and docetaxel in participants with mCRPC previously treated with second-generation AR (Androgen Receptor)-targeted therapy. The study consists of two parts: [1] Part A: Safety run-in cohort of approximately 12 participants; [2] Part B: Expansion cohort of approximately 38 participants. All participants in this study will continue to be treated until progression of disease, loss of clinical benefit, unacceptable toxicity or withdrawal of consent.

location_country:
Italy
Switzerland
France
Spain
United States

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Miami Cancer Institute of Baptist Health, Inc.

location_facility: Maryland Oncology Hematology; Maryland Oncology Hematology, PA

location_facility: Centre Val Aurelle Paul Lamarque; Radiotherapie

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

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

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: Azienda Ospedaliera S. Maria - Terni; Oncologia

location_facility: Irccs Centro Di Riferimento Oncologico (CRO)

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: Vall d´Hebron Institute of Oncology (VHIO), Barcelona


title: A Phase II Study of Cemiplimab, an Anti-PD-1 Monoclonal Antibody, and ISA101b Vaccine in Patients With Recurrent/Metastatic HPV16 Positive Oropharyngeal Cancer Who Have Experienced Disease Progression With Prior Anti-PD-1 Therapy

summary: This will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab.

lead_sponsor: ISA Pharmaceuticals

location_country:
Italy
United States
France
Czechia
Belgium
Spain
Germany

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: The University of Texas M. D. Anderson Cancer Center

location_facility: CHU La Timone - La Timone Children's Hospital


title: A Phase 2/3, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and the Safety of ABX464 in Treating Inflammation and Preventing COVID-19 Associated Acute Respiratory Failure in Patients Aged ≥ 65 and Patients Aged ≥18 With at Least One Additional Risk Factor Who Are Infected With SARS-CoV-2.

acronym: Mir-Age

summary: A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the efficacy and the safety of ABX464 in treating inflammation and preventing acute respiratory failure in patients aged ≥65 and patients aged ≥18 with at least one additional risk factor who are infected with SARS-CoV-2 (the MiR-AGE study).

status: Terminated

lead_sponsor: Abivax S.A.

location_country:
Italy
Brazil
Mexico
France
Belgium
Spain
Germany
United Kingdom

location_facility: Instituto Nacional de Infectologia Evandro Chagas - FIOCRUZ Rio de Janeiro

location_facility: Ospedale di Vittorio Veneto - Medecina generale

location_facility: Centro Oncológico de Roraima - CECOR - NAP

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centro de Prevención y Rehabilitación de Enfermedades Pulmon

location_facility: Universitätsmedizin Mannheim Ruprecht-Karls-Universität Heid

location_facility: Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Infectious Diseases

location_facility: Ospedale A. Manzonidi Lecco - ASST Lecco

location_facility: Centre Hospitalier Départemental de Vendée

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - Instituto de Pesquisa Clínica Carlos Borborema

status_simplified: Unknown


title: A Phase Ib Trial to Evaluate the Efficacy and Safety of Bintrafusp Alfa Monotherapy in Metastatic or Locally Advanced/Unresectable Urothelial Cancer With Disease Progression or Recurrence Following Treatment With a Platinum Agent

summary: The purpose of this study is to evaluate bintrafusp alfa in participants with metastatic or locally advanced urothelial cancer. This trial provides the first evaluation of bintrafusp alfa in participants with urothelial cancer that has progressed following platinum therapy

lead_sponsor: GlaxoSmithKline

location_country:
Netherlands
France
Spain
United States
United Kingdom
Canada


title: A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (Galcanezumab) in Patients With Episodic or Chronic Cluster Headache

summary: The main purpose of this study is to assess the long-term safety and tolerability of galcanezumab administered up to once monthly in participants with episodic or chronic cluster headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM (NCT02438826).

ipd_sharing_description:
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Italy
United States
Netherlands
Germany
Finland
France
Greece
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Migräne- und Kopfschmerzklinik GmbH & Co. KG

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Michigan Head, Pain and Neurological Institute

location_facility: New England Institute for Clinical Research

location_facility: Fondazione Istituto Neurologico Nationale C. Mondino

location_facility: Walton Centre for Neurology and Neurosurgery

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Centre Hospitalier Regional de la Citadelle


title: A Phase Ia/Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Patients With Locally Advanced or Metastatic Tumors

summary: This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and PK of tiragolumab alone or in combination with atezolizumab and/or other anti-cancer therapies in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate, or for whom a clinical trial of an investigational agent is a recognized standard of care.

lead_sponsor: Genentech, Inc.

location_country:
Italy
United States
France
Australia
Spain
Canada
Korea, Republic of

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: ICO L'Hospitalet; Servicio de oncologia medica

location_facility: Uni of Pittsburgh Cancer Inst. ; Oncology

location_facility: Hospital Universitario Virgen de la Victoria ; Servicio de Farmacia

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

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

location_facility: Kinghorn Cancer Centre; St Vincents Hospital

location_facility: Rhode Island Hospital; Pharmacy Department

location_facility: Hospital Universitario HM Sanchinarro-CIOCC; Oncología Médica

location_facility: Hospital General Universitario de Alicante - Farmacia; Servicio de Farmacia

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Complejo Hospitalario Universitario Insular-Materno Infantil

location_facility: Clinica Universitaria de Navarra; Servicio de oncología

location_facility: Hospital Clinico Universitario de Valencia


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)

acronym: SUNRISE 1

summary: This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2 nights of 1 month of treatment in participants 55 years and older with insomnia disorder.

ReferenceCitation: Citrome L, Juday T, Frech F, Atkins N Jr. Lemborexant for the Treatment of Insomnia: Direct and Indirect Comparisons With Other Hypnotics Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2021 Jun 1;82. pii: 20m13795. doi: 10.4088/JCP.20m13795.

family: Citrome

full_name: Leslie Citrome

given: Leslie

family: Juday

full_name: Timothy Juday

given: Timothy

family: Ferch

full_name: Feride Ferch

given: Feride

family: Atkins

full_name: Norman Atkins

given: Norman

journal_name: The Journal of Clinical Psychiatry

evidence: open (via free pdf)

license_normalized: no license

publisher: Physicians Postgraduate Press, Inc

publisher_dissemination: Physicians Postgraduate Press, Inc

publisher_group: Physicians Postgraduate Press, Inc

publisher_normalized: Physicians Postgraduate Press, Inc

ReferenceCitation: Moline M, Zammit G, Cheng JY, Perdomo C, Kumar D, Mayleben D. Comparison of the effect of lemborexant with placebo and zolpidem tartrate extended release on sleep architecture in older adults with insomnia disorder. J Clin Sleep Med. 2021 Jun 1;17(6):1167-1174. doi: 10.5664/jcsm.9150.

family: Moline

full_name: Margaret Moline

given: Margaret

name: Clinilabs Drug Development Corporation, New York, New York

family: Zammit

full_name: Gary Zammit

given: Gary

family: Cheng

full_name: Jocelyn Y. Cheng

given: Jocelyn Y.

family: Perdomo

full_name: Carlos Perdomo

given: Carlos

family: Kumar

full_name: Dinesh Kumar

given: Dinesh

family: Mayleben

full_name: David Mayleben

given: David

journal_name: Journal of Clinical Sleep Medicine

publisher: American Academy of Sleep Medicine (AASM)

ReferenceCitation: Rosenberg R, Murphy P, Zammit G, Mayleben D, Kumar D, Dhadda S, Filippov G, LoPresti A, Moline M. Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1918254. doi: 10.1001/jamanetworkopen.2019.18254. Erratum in: JAMA Netw Open. 2020 Apr 1;3(4):e206497. JAMA Netw Open. 2021 Aug 2;4(8):e2127643.

family: Rosenberg

full_name: Russell Rosenberg

given: Russell

family: Murphy

full_name: Patricia Murphy

given: Patricia

family: Dhadda

full_name: Shobha Dhadda

given: Shobha

family: Filippov

full_name: Gleb Filippov

given: Gleb

family: LoPresti

location_country:
Italy
United States
France
Spain
Germany
United Kingdom
Canada

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Medical University of South Carolina - PPDS

location_facility: Zentralinstitut für Seelische Gesundheit

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS

location_facility: Hospital Universitario Araba - Txagorritxu

location_facility: Fleming Island Center For Clinical Research

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

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Sleep Medicine Centers of Western New York

location_facility: Saint Francis Sleep Allergy and Lung Institute

location_facility: Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Clinical Research Group of St Petersburg Inc

location_facility: Quest Pharmaceutical Services-Miami Research Associates, LLC (QPS MRA)

location_facility: Orange County Neuropsychiatric Research Center, LLC

location_facility: Sleep Disorders Center of the Mid-Atlantic

location_facility: Artemis Institute For Clinical Research LLC


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.

lead_sponsor: AbbVie

location_country:
Finland
Greece
Belgium
Denmark
France
Norway
Canada
Sweden
Switzerland
Netherlands
Ireland
Puerto Rico
Portugal
United States
Germany
United Kingdom
Italy
Austria
Israel
Spain
Turkey

acronym: VENICE I

location_facility: Hospital Santa Creu i Sant Pau /ID# 151230

location_facility: Hopitaux Universitaires de Geneve /ID# 147930

location_facility: Sunnybrook Health Sciences Ctr /ID# 147462

location_facility: West Virginia Univ School Med /ID# 151602

location_facility: CHRU de Brest - Hopital Morvan /ID# 147485

location_facility: Puerto Rico Hematology Oncolog /ID# 150003

location_facility: CHU de Quebec-Universite Laval /ID# 150299

location_facility: General Hospital of Athens Laiko /ID# 147517

location_facility: Southampton General Hospital /ID# 147646

location_facility: Tel Aviv Sourasky Medical Ctr /ID# 151624

location_facility: Hospital Clinico Univ de Salamanca /ID# 147392

location_facility: Cent fuer Haematologie und Onk /ID# 147511

location_facility: Vehbi Koc vakfi Amerikan Hasta /ID# 147325

location_facility: OncoResearch Lerchenfeld GmbH /ID# 164044

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 147503

location_facility: Albert Schweitzer Ziekenhuis /ID# 147495

location_facility: Cliniques Universitaires Saint Luc /ID# 147388

location_facility: Ospedale Regional Bellinzona e /ID# 151232

location_facility: Ondokuz mayis University Facul /ID# 147326

location_facility: The Royal Wolverhampton NHS Tr /ID# 147945

location_facility: Skanes Universitetssjukhus Lund /ID# 147439

location_facility: Hanusch Krankenhaus der WGKK /ID# 147548

location_facility: Onkologische Schwerpunktpraxis /ID# 147516

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 147505

location_facility: Univ Hosp Bristol NHS Foundati /ID# 147647

location_facility: Haukeland University Hospital /ID# 147382

location_facility: Istanbul University Istanbul Medical Faculty /ID# 156040

title: Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Efficacy of Venetoclax (ABT 199) in Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL)

summary: The purpose of this study is to evaluate the efficacy of venetoclax monotherapy in participants with relapsed/refractory CLL including those with the 17p deletion or TP53 mutation OR those who have received prior treatment with a B-cell receptor inhibitor.


lead_sponsor: argenx

location_country:
Italy
Austria
Netherlands
Germany
France
Czechia
Bulgaria
Japan
Poland
Hungary
Belgium
Russian Federation
Spain
Turkey
United States
United Kingdom
Ukraine

acronym: ADVANCE+

location_facility:
Investigator Site 0810021
Investigator Site 0900006
Investigator Site 0900009
Investigator Site 0390010
Investigator Site 0810015
Investigator Site 0900015
Investigator Site 0010037
Investigator Site 0360015
Investigator Site 0070006
Investigator Site 3800006
Investigator Site 0900016
Investigator Site 0330018
Investigator Site 0810016
Investigator Site 0430002
Investigator Site 0390014
Investigator Site 3590001
Investigator Site 0390009
Investigator Site 0810022
Investigator Site 0810023
Investigator Site 0320002
Investigator Site 0330016
Investigator Site 0010042
Investigator Site 0330008
Investigator Site 0340011
Investigator Site 0900007
Investigator Site 4200001
Investigator Site 0440008
Investigator Site 0390016
Investigator Site 3590002
Investigator Site 0360010
Investigator Site 0320014
Investigator Site 0430003
Investigator Site 0390020
Investigator Site 0390015
Investigator Site 0390018
Investigator Site 0310005
Investigator Site 0900017
Investigator Site 0330009
Investigator Site 0010040
Investigator Site 0340006
Investigator Site 0070008
Investigator Site 0810018
Investigator Site 0340015
Investigator Site 0070015
Investigator Site 0310006
Investigator Site 0480014
Investigator Site 0480012
Investigator Site 0320011
Investigator Site 0490010
Investigator Site 0360006
Investigator Site 0810017
Investigator Site 0340014
Investigator Site 0340012
Investigator Site 0360014
Investigator Site 4200008
Investigator Site 4200007
Investigator Site 0480011
Investigator Site 0070007
Investigator Site 0070009
Investigator Site 0070012
Investigator Site 0390019
Investigator Site 0340013
Investigator Site 0340004
Investigator Site 0900019
Investigator Site 0070010
Investigator Site 0900013
Investigator Site 0320012
Investigator Site 4200006
Investigator Site 0480013
Investigator Site 0340009
Investigator Site 0480026
Investigator Site 0900004
Investigator Site 0490008
Investigator Site 0900003
Investigator Site 0010045
Investigator Site 0810014
Investigator Site 0900010
Investigator Site 0390011
Investigator Site 0340007
Investigator Site 0070013
Investigator Site 0360004

title: A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia.

summary: This is an open-label long-term multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in adult patients with primary ITP.


title: A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

summary: The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for the treatment of adult participants with NMOSD.

lead_sponsor: Alexion Pharmaceuticals

location_country:
Italy
Austria
United States
Germany
France
Japan
Poland
Australia
Spain
Denmark
Canada
United Kingdom
Korea, Republic of


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 TRIAL)

summary: The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.

lead_sponsor: Cerevel Therapeutics, LLC

location_country:
Italy
United States
Germany
France
Czechia
Bulgaria
Israel
Poland
Australia
Spain
Canada
Ukraine

location_facility:
Columbus, Ohio
Zaporiizhzhya
Ormond Beach, Florida
Ramat Gan
Las Vegas, Nevada
Ottawa, Ontario
Rychnov nad Kněžnou
Stadtroda
Multiprofile Hospital, Sofia
Las Vegas, Nevada,
Medical center VITA1, Pleven
Englewood, Colorado
Boulevard Pinel, Bron
Lublin
Philadelphia, Pennsylvania
Toronto, Ontario
Lexington, Kentucky
Madrid
Poliklinika, Chocen,
Elche
Kharkiv
Atlantis, Florida
Kansas City, Kansas
Fountain Valley, California
Scarborough, Maine
Muenster
Spokane, Washington
Asheville, North Carolina
Petah Tiqva
Los Angeles, California
Bad Homburg
Zaporozhya
Terrassa
Erina, New South Wales
Pisa
Durham, North Carolina
Nîmes cedex
Ville de Quebec
Boston, Massachusetts
Georgetown, Texas
Toledo, Ohio
Farmington Hills, Michigan
Valencia
Warsaw
Haag in Oberbayern
Lubbock, Texas
Tel Aviv
Denver, Colorado
Chicago, Illinois
Westerstede
Katowice
Lodz
Birmingham, Alabama
East Lansing, Michigan
Prague,
Shoham
Duesseldorf,
Adventura, Florida
Augusta, Georgia
Woolloongabba, Queensland
Pheonix, Arizona
Ashkelon
Creteil
Dayton, Ohio
Haifa
Houston, Texas
Jerusalem
Barcelona
Virginia Beach, Virginia
Dnipro
Winfield, Illinois
Tampa, Florida
Sofia
Grenoble cedex
Parkville, Victoria
Milano
Rome
Little Rock, Arkansas
Pasadena, California
Boca Raton, Florida
Reseda, California
Sevilla
Kraków
Burlington, Vermont
Pleven


title: A Multi-centre Long Term Follow-up Study to Assess the Durability of Sustained Virologic Response in Alisporivir-treated Chronic Hepatitis C Patients

summary:
The purpose of this study is to follow-up with participants from feeder studies who achieved sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma and post-treatment safety over time.

Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301 (NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks with a maximum of 3 visits. No treatment is involved.

lead_sponsor: Debiopharm International SA

location_country:
Romania
Belgium
Australia
Russian Federation
Taiwan
India
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Hong Kong
Vietnam
Hungary
United States
Germany
United Kingdom
Italy
Mexico
Spain
Turkey


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.

lead_sponsor: AstraZeneca

location_country:
Italy
Austria
Switzerland
Germany
France
Japan
Poland
Israel
Belgium
Denmark
United States

acronym: NATRON

title: A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24-week Phase 3 Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES)

summary: This is a multicentre, randomised, double-blind (DB), parallel-group, placebo-controlled, 24-week Phase 3 study to compare the efficacy and safety of benralizumab versus placebo administered by SC injection Q4W in patients with hypereosinophilic syndrome (HES). This study comprises 2 distinct periods (together defined as the 'main study'): A 24-week, DB treatment period, during which patients will be randomised to receive either benralizumab or placebo, in addition to prior stable HES background therapy, and an open-label (OLE) treatment period, during which all patients will receive benralizumab. Patients will not continue to be recruited after 47 patients have had their first HES worsening/flare.The primary database lock (DBL) will occur when at least 47 patients have had their first HES worsening/flare event and all randomised patients have been followed up for the 24-week DB treatment period. The target patient population is male and female patients 12 years of age and older with symptomatic active HES. Approximately 120 eligible patients will be randomised at a 1:1 ratio to receive either benralizumab or matching placebo


title: A Phase 3, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Efficacy, Safety, and Tolerability of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo in Symptomatic Subjects With PAH (Part 1 and Part 2)

summary: Phase 3, placebo controlled, double-blind, randomized clinical study to determine safety, tolerability, and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial hypertension (PAH). Part 1 and Part 2

lead_sponsor: Bellerophon Pulse Technologies

location_country:
Italy
Austria
United States
Serbia
Netherlands
Spain
Germany
Croatia
Czechia
France
Israel
Australia
Belgium
Portugal
Canada
United Kingdom
Colombia
Ukraine

location_facility: Clinical Center of Serbia, Polyclinic, Pulomology Department

location_facility: "Universitätsklinikum Freiburg - Medizinische Universitätsklinik

location_facility: Toronto General Hospital, University Health Network

location_facility: Wellstar Medical Group - Pulmonary Medicine

location_facility: Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen - Hopital Charles Nicolle

location_facility: NYU Medical Center, Division Pulmonary, Critical Care and Sleep Medicine

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: New York Presbyterian Brooklyn Methodist Hospital - Division of Pulmonary/Critical Care/Sleep

location_facility: Lawson Clinical Research Services / London Health Sciences Centre - VH

location_facility: Hôpital Arnaud De Villeneuve - Service des Maladies Respiratoires

location_facility: Lviv Regional Clinical Hospital, Department of Intesive Care #2

location_facility: Unfallkrankenhaus Berlin-Klinik für Innere Medizin/Kardiologie

location_facility: Innsbruck Medical University, University Hospital for Internal Medicine VI, Pneumology

location_facility: Bluhm Cardiovascular Institute, Clinical Trials Unit

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg -

location_facility: National institute of phthisiology and pulmonology

location_facility: Clinical Center of Serbia Department of Cardiology and Polyclinic

location_facility: Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery of Dnipropetrovsk Regional Council, Department of Cardiology

location_facility: Hospital Universitario Puerta de Hierro - Madrid

location_facility: Centre Hospitalier Universitaire de Grenoble (CHU Grenoble) - Clinique de Pneumologie

location_facility: CHU de Nice Hôpital Pasteur - Pavillon H - Service Pneumologie

location_facility: Municipal Institution of health care "Kharkiv City Clinical Hospital №13", Pulmonology Department №1

location_facility: Universitätsmedizin Greifswald Zentrum für innere Medizin Klinik und Poliklinik für Innere Medizin B

location_facility: Universitätsklinikum Leipzig-Dept. für Innere MedizinAbteilung für Pneumologie

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: University of Arizona Sarver Heart Center

location_facility: Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

location_facility: UC San Diego / Pulmonary, Critical Care and Sleep Medicine Division

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

location_facility: AKH-Vienna, Medical University of Vienna

location_facility: Government Institution "L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine", Cardiopulmonology Department

location_facility: Hospital Universitario Marques de Valdecilla (HUMV)

location_facility: Piedmont Healthcare Pulmonary and Critical Care Research

location_facility: Faculty of Medicine / Peter Lougheed Center / Respiratory Research

location_facility: Clinical Center of Nis, Clinic for Cardiovascular Diseases

location_facility: National Scientific Centre "M.D. STRAZHESKO INSTITUTE OF CARDIOLOGY, MAS OF UKRAINE"

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg-Zentrum für Pulmonale Hypertension

location_facility: Vseobecna Fakultni Nemocnice v Praze (VFN)

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: University of Cincinnati Medical Ctr, Dept of Internal Medicine / Pulmonary, Critical Care & Sleep Medicine

location_facility: Montefiore Medical Center - Weiler Division

location_facility: University of California, Davis Medical Center

location_facility: A.O.U. Policlinico Umberto I- Università La Sapienza

location_facility: Medizinische Hochschule Hannover-Abteilung für Pneumologie

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Kentuckiana Pulmonary Associates (KPA), Inc. - Louisville

location_facility: Waldburg-Zeil Kliniken - Fachkliniken Wangen Klinik für Pneumologie

location_facility: University of Texas Southwestern Medical Center of Dallas

location_facility: Winthrop University Hospital, Clinical Trials Center

location_facility: Universidade de Coimbra - Hospitais da Universidade de Coimbra (H.U.C)

location_facility: Klinikum der Universität Regensburg - Klinik und Poliklinik für Innere Medizin II

location_facility: Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Medizinische Klinik und Poliklinik I


lead_sponsor: Millennium Pharmaceuticals, Inc.

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

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: The Center for Cancer and Blood Disorders

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Institut de Cancerologie de l'Ouest Paul Papin

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust

location_facility: Beskidzkie Centrum Onkologii im.Jana Pawla II

location_facility: Instytut MSF, Ulica Pilota Stanislawa Wigury 19

location_facility: Groupe Hospitalier Saint Andre - Hopital Saint Andre

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: ICL-Alexis Vautrin, Departement dOncologie Medicale

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital

location_facility: Hackensack University Medical Center PARTNER

type: Registry Identifier

title: A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Single-Agent MLN0128 and the Combination of MLN0128+MLN1117 Compared With Everolimus in the Treatment of Adult Patients With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma That Has Progressed on Vascular Endothelial Growth Factor-Targeted Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of single-agent MLN0128 and the combination of MLN0128 + MLN1117 compared with everolimus in the treatment of participants with metastatic clear-cell renal cell carcinoma (mccRCC) that have progressed on vascular endothelial growth factor (VEGF)-targeted therapy.


title: An Open-label, Multicentre, Dose-escalating Phase I/II Trial of 3-weekly Ocrelizumab in Patients With Follicular Non-Hodgkin's Lymphoma (NHL)

summary: This study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of ocrelizumab in participants with progressive follicular NHL.

lead_sponsor: Hoffmann-La Roche

location_country: Italy Sweden Switzerland France Australia Canada


ReferenceCitation: Dimopoulos MA, Dytfeld D, Grosicki S, Moreau P, Takezako N, Hori M, Leleu X, LeBlanc R, Suzuki K, Raab MS, Richardson PG, Popa McKiver M, Jou YM, Shelat SG, Robbins M, Rafferty B, San-Miguel J. Elotuzumab plus Pomalidomide and Dexamethasone for Multiple Myeloma. N Engl J Med. 2018 Nov 8;379(19):1811-1822. doi: 10.1056/NEJMoa1805762.

name: From the National and Kapodistrian University of Athens, Athens (M.A.D.); Karol Marcinkowski University of Medical Sciences, Poznań (D.D.), and Silesian Medical University, Katowice (S.G.) — both in Poland; University Hospital, Nantes (P.M.), and Centre Hospitalier Universitaire de Poitiers–La Milétrie, Poitiers (X.L.) — both in France; National Hospital Organization Disaster Medical Center (N.T.) and the Japanese Red Cross Medical Center (K.S.), Tokyo, and Ibaraki Prefectural Central Hospital, Kasama (M...

family: Dimopoulos

full_name: Meletios A. Dimopoulos

given: Meletios A.

family: Dytfeld

full_name: Dominik Dytfeld

given: Dominik

family: Grosicki

full_name: Sebastian Grosicki

given: Sebastian

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Takezako

full_name: Naoki Takezako

given: Naoki

family: Hori

full_name: Mitsuo Hori

given: Mitsuo

family: Leleu

full_name: Xavier Leleu

given: Xavier

family: LeBlanc

full_name: Richard LeBlanc

given: Richard

family: Suzuki

full_name: Kenshi Suzuki

given: Kenshi

family: Raab

full_name: Marc S. Raab

given: Marc S.

family: Richardson

full_name: Paul G. Richardson

given: Paul G.

family: Popa McKiver

full_name: Mihaela Popa McKiver

given: Mihaela

family: Jou

full_name: Ying-Ming Jou

given: Ying-Ming

family: Shelat

full_name: Suresh G. Shelat

given: Suresh G.

family: Robbins

full_name: Michael Robbins

given: Michael

family: Rafferty

full_name: Brian Rafferty

given: Brian

family: San-Miguel

full_name: Jesús San-Miguel

given: Jesús

journal_name: New England Journal of Medicine

evidence: open (via free article)

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
Netherlands
Germany
France
Japan
Greece
Poland
Australia
Spain
Canada

location_facility: Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino

location_facility: Investigative Clinical Research Of Indiana, Llc

location_facility: CIUSSS de l'Est-de-L'Ile-de-Montreal - Hopital Maisonneuve-Rosemont

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona

location_facility: Oddzial Hematologii i Transplantacji Szpiku

location_facility: Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: A. O. U. Di Bologna, Policlinico S. Orsola Malpighi

location_facility: Klinikum Der Johannes Gutenberg Universitaet Mainz

title: An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)

summary: The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma compared to pomalidomide and low-dose dexamethasone by itself.


ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Italy
United States
Switzerland
Netherlands
France
Israel
Spain
Germany
United Kingdom
Canada

acronym: INDIGO

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: St. Joseph's Hospital & Medical Center - Barrow Neurological Institute

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

location_facility: University of California Irvine - Hospital

location_facility: University of Pittsburgh Hillman Cancer Center

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Sylvester Comprehensive Cancer Center - University of Miami Hospital and Clinics

location_facility: The University of Utah, Huntsman Cancer Hospital

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: University of Texas Southwestern Medical Center

title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation

summary: Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization. Approximately 340 participants are planned to be randomized 1:1 to receive orally administered vorasidenib 40 mg QD or placebo.


title: A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Benralizumab in Patients With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)

acronym: ORCHID

summary: This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg administered subcutaneously (SC) versus placebo in patients with severe nasal polyposis.

ReferenceCitation: Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3:CD013513. doi: 10.1002/14651858.CD013513.pub3.

name: Nuffield Department of Surgical Sciences; University of Oxford; Oxford UK

family: Chong

full_name: Lee-Yee Chong

given: Lee-Yee

name: Department of Otorhinolaryngology; Faculty of Medicine, Khon Kaen University; Khon Kaen Thailand

family: Piromchai

full_name: Patorn Piromchai

given: Patorn

name: National Institute for Health and Care Excellence; Manchester UK

family: Sharp

full_name: Steve Sharp

given: Steve

name: Department of Otolaryngology, Faculty of Medicine; Chulalongkorn University; Bangkok Thailand

family: Snidvongs

full_name: Kornkiat Snidvongs

given: Kornkiat

name: Cochrane ENT; Nuffield Department of Surgical Sciences, University of Oxford; Oxford UK

family: Webster

full_name: Katie E Webster

given: Katie E

name: Department of Medicine; Norwich Medical School, University of East Anglia; Norwich UK

family: Philpott

full_name: Carl Philpott

given: Carl

name: ENT Department; Guy's Hospital; London UK

family: Hopkins

full_name: Claire Hopkins

given: Claire

family: Burton

full_name: Martin J Burton

given: Martin J

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University of East Anglia - UEA Digital Repository

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Biologics for chronic rhinosinusitis

location_country:
Italy
Sweden
Vietnam
France
Japan
Poland
Thailand
Hungary
Belgium
Argentina
Australia
China
Russian Federation
United States
Turkey
Taiwan


title: A Randomized, Open-label, Two Arm, Parallel Group, Proof-of-concept Clinical Trial to Investigate the Efficacy and Safety of LNP023 Compared With Rituximab in the Treatment of Subjects With Idiopathic Membranous Nephropathy

summary: This is a randomized, open-label, two arm, parallel group, proof-of-concept, non-confirmatory study evaluating the efficacy and safety of LNP023 compared with rituximab in subjects with membranous nephropathy (MN) who are at high risk of disease progression defined on the basis of antibody anti-PLA2R titre and proteinuria.

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:
United States
India
Netherlands
France
Czechia
Singapore
Argentina
Spain
Germany
United Kingdom
Taiwan


title: HELIOS-B: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

summary: This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in patients with ATTR amyloidosis with cardiomyopathy.

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Peru
Malaysia
Australia
Belgium
Denmark
Croatia
France
Japan
Lithuania
Poland
Norway
Thailand
Argentina
Moldova, Republic of
Canada
Slovenia
Korea, Republic of
Colombia
Sweden
Netherlands
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Austria
Lebanon
Czechia
Israel
Spain
Latvia


publications_result: Segal-Maurer S, Castagna A, Berhe M, et al. Potent Antiviral Activity of Lenacapavir in Phase 2/3 in Heavily ART-Experienced PWH [Abstract 127]. Presented at: Conference on Retroviruses and Opportunistic Infections; 2021 March 6-10.

ReferenceType: result

lead_sponsor: Gilead Sciences

location_country:
Italy
United States
South Africa
Dominican Republic
France
Japan
Thailand
Spain
Germany
Canada
Taiwan

acronym: CAPELLA

location_facility: UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: AIDS Arms, Inc. DBA Prism Health North Texas

location_facility: AIDS Healthcare Foundation - South Beach

location_facility: St. Joseph's Hospital Comprehensive Research Institute

location_facility: Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)

location_facility: Universitätsklinikum Frankfurt, Medizinische Klinik II

location_facility: Instituto Dominicano de Estudios Virologicos (IDEV)

location_facility: Hospital Dr. Salvador Bienvenido Gautier

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: North Shore University Hospital/Division of Infectious Diseases

location_facility: Clinique de médecine urbaine du Quartier Latin

location_facility: Durban International Clinical Research Site, Enhancing Care Foundation

location_facility: Atrium Health- Infectious Disease Consultants

location_facility: Bamrasnaradura Infectious Diseases Institute

location_facility: U.O.C. IMMUNODEFICIENZE VIRALI - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS

location_facility: Faculty of Medicine Ramathibodi Hospital, Mahidol University

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

location_facility: Hospital Universitari Germans Trías i Pujol

location_facility: Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania

location_facility: North Texas Infectious Diseases Consultants, P.A.

location_facility: Faculty of Medicine Siriraj Hospital, Mahidol University

location_facility: Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie

location_facility: Midland Florida Clinical Research Center, LLC

location_facility: U.O.C. Malattie Infettive - Fondazione Policlinico Universitario A. Gemelli IRCCS

location_facility: Taoyuan General Hospital, Ministry of Health and Welfare

location_facility: Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Emory Hospital Midtown Infectious Disease Clinic

location_facility: Vancouver ID Research and Care Centre Society

location_facility: Maple Leaf Research/Maple Leaf Medical Clinic

location_facility: Faculty of Medicine, Khon Kaen University

title: A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long Acting Capsid Inhibitor GS-6207 in Combination With an Optimized Background Regimen in Heavily Treatment Experienced People Living With HIV-1 Infection With Multidrug Resistance

summary: The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen (functional monotherapy) in people with HIV (PWH) with multi-drug resistance (MDR).


title: A Phase Ib, Open-label, Randomized Study to Assess Safety and Preliminary Efficacy of Tafasitamab in Addition to R-CHOP or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) - First-MIND

summary: This is an open-label, randomized, multicentre study to evaluate safety and preliminary efficacy of the human anti-CD19 antibody Tafasitamab in addition to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristin, Prednison) or Tafasitamab and Lenalidomide in addition to R-CHOP in adult patients with newly diagnosed, previously untreated Diffuse Large B-cell Lymphoma (DLBCL).

lead_sponsor: MorphoSys AG

location_country:
Italy
Austria
Spain
Germany
France
Czechia
Belgium
Portugal
United States

location_facility:
Medizinische Universtät Innsbruck
MorphoSys Research Site


title: A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

summary: The purpose of the MycarinGstudy is to evaluate the long-term safety, tolerability and long-term efficacy of rozanolixizumab in study participants with generalized myasthenia gravis (MG).

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:
Italy
Germany
France
Czechia
Japan
Poland
Russian Federation
Spain
Denmark
United States
Canada
Taiwan


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)

summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, when administered alone and in combination with low-dose cytarabine (LDAC) or Decitabine for the treatment of adults with Acute Myeloid Leukemia (AML) and AML secondary to myeloproliferative neoplasms (MPN). Participants must be relapsed/refractory (having failed prior therapy) and will be assigned to receive monotherapy (KRT-232 alone) or combination therapy (KRT-232 with LDAC or KRT-232 with Decitabine).

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Italy
Germany
France
Israel
Hungary
Belgium
Australia
Spain
United States
United Kingdom
Korea, Republic of

location_facility: szabolcs-szatmár-bereg megyei kórházak és egyetemi oktatókórház Jósa András Oktatókórház

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Hospital Clínico Universitario de Valencia

location_facility: AORMN Hospital Hematology and BMT Center

location_facility: Centre Hospitalier Universitaire (CHU) de Nice

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

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux

location_facility: Hospital Universitario Virgen de la Victoria de Málaga


title: An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Eligible Subjects With CSU Who Have Participated in Preceding Studies With LOU064

summary: This study is an open-label, single arm, multicenter, long-term safety and tolerability extension study for CSU patients who completed CLOU064A2201 or other preceding studies with LOU064

location_country:
United States
France
Czechia
Japan
Poland
Slovakia
Hungary
Belgium
Argentina
Russian Federation
Spain
Turkey
Denmark
Canada
United Kingdom