acronym: Olaparib in combination with pembrolizumab in HRRm and HRD positive cancer

summary: The purpose of this study is to assess the efficacy and safety of treatment with olaparib (MK-7339) in combination with pembrolizumab (MK-3475) in adults with previously treated, advanced (metastatic and/or unresectable) Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-positive solid tumors.

ReferenceCitation: Cannon TL, Randall JN BA, Sokol ES, Alexander SM, Wadlow RC, Winer AA, Barnett DM, Rayes DL BS, Nimeiri HS, McGregor KA. Concurrent BRAFV600E and BRCA Mutations in MSS Metastatic Colorectal Cancer: Prevalence and Case Series of mCRC patients with prolonged OS. Cancer Treat Res Commun. 2022;32:100569. doi: 10.1016/j.ctarc.2022.100569. Epub 2022 Apr 30.

evidence: oa journal (via doaj)

unpaywall_oa_status: gold

location_facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0703)

location_facility: Clinica Integral Internacional de Oncologia S. de R.L. de C.V. ( Site 3107)

location_facility: University of Texas-MD Anderson Cancer Center ( Site 0087)

location_facility: Inonu Universitesi Medical Fakultesi ( Site 1506)

location_facility: Ad-Vance Medical Research LLC ( Site 0505)

location_facility: Podillya Regional Center of Oncology ( Site 1708)

location_facility: Northeast Georgia Medical Center ( Site 0026)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1504)

location_facility: Institut du Cancer de Montpellier ( Site 0610)

location_facility: Japanese Foundation for Cancer Research ( Site 2503)

location_facility: Tasman Oncology Research Pty Ltd ( Site 2203)

location_facility: Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient (

location_facility: Severance Hospital Yonsei University Health System ( Site 2400)

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 3101)

location_facility: Northwest Georgia Oncology Centers PC ( Site 0047)

location_facility: CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 3103)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1510)

location_facility: Unidad Biomedica Avanzada Monterrey S. A. ( Site 3108)

location_facility: Spitalul Judetean de Urgenta Alba Iulia ( Site 1107)

location_facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 3002)

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 3206)

location_facility: Daugavpils Regional Hospital ( Site 2104)

location_facility: Okayama University Hospital ( Site 2505)

location_facility: Seoul National University Hospital ( Site 2402)

location_facility: Mary Potter Oncology Centre, Little Company of Mary Hospital ( Site 1900)

location_facility: Hokkaido University Hospital ( Site 2502)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Universitas Annex National Hospital ( Site 1902)

location_facility: Fundación Colombiana de Cancerología Clínica Vida ( Site 2902)

location_facility: Linear Clinical Research Ltd ( Site 2206)

location_facility: Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi ( Site 1501)

location_facility: Sanatorio Nuestra Senora del Pilar ( Site 3006)

location_facility: Fundacion Cardiovascular de Colombia ( Site 2907)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1300)

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1700)

location_facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 0700)

location_facility: Hospital Clinic i Provincial ( Site 1302)

location_facility: New York Cancer and Blood Specialists-Research Department ( Site 0080)

location_facility: Medical Centre Consilium Medical ( Site 1712)

location_facility: University of California San Francisco ( Site 0015)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi ( Site 1505)

location_facility: Banner MD Anderson Cancer Center ( Site 0049)

location_facility: University Hospitals Cleveland Medical Center ( Site 0016)

location_facility: Baskent University Adana Training Hospital ( Site 1509)

location_facility: Hospital Nacional Adolfo Guevara Velasco ( Site 3205)

location_facility: Hospital Nacional Arzobispo Loayza ( Site 3208)

location_facility: San Francisco Oncology Associates ( Site 0085)

location_facility: Khmelnitskiy Regional Onkology Dispensary ( Site 1705)

location_facility: The University of Oklahoma Health Sciences Center ( Site 0050)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 1702)

location_facility: National Cancer Center Hospital ( Site 2501)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0201)

location_facility: Centro Oncologico Riojano Integral ( Site 2703)

location_facility: Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1500)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 3201)

location_facility: Gazi Universitesi Tip Fakultesi ( Site 1507)

location_facility: P. Stradina Clinical University Hospital ( Site 2102)

location_facility: Hematology and Oncology Institute ( Site 0504)

location_facility: Azienda Ospedaliera Universitaria Senese ( Site 0704)

location_facility: Charite-Universitaetsmedizin Berlin-Campus Benjamin Franklin ( Site 0902)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1101)

location_facility: Akdeniz Universitesi Tıp Fakultesi ( Site 1503)

location_facility: Northwest Medical Specialties, PLLC ( Site 0007)

location_facility: Universitaetsklinik der Ludwig-Maximilians-Universitaet Muenchen ( Site 0906)

location_facility: Medical center of the Limited Liability Company Yulis ( Site 1714)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 2000)

location_facility: Zhytomyr Regional Oncology Center ( Site 1710)

location_facility: UC Davis Comprehensive Cancer Center ( Site 0039)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 0705)

location_facility: Banner MD Anderson Cancer Center ( Site 0092)

location_facility: National Cancer Center Hospital East ( Site 2500)

location_facility: Centro Medico Zambrano Hellion ( Site 3105)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0206)

location_facility: Uniwersyteckie Centrum Kliniczne ( Site 1809)

location_facility: Aichi Cancer Center Hospital ( Site 2504)

location_facility: University of Texas, Southwestern Medical Center ( Site 0004)

location_facility: Hospital Nacional Cayetano Heredia ( Site 3203)

location_facility: Winship Cancer Institute of Emory University ( Site 0057)

location_facility: Cancercare Rondebosch Oncology ( Site 1901)

location_facility: Inova Schar Cancer Institute ( Site 0008)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1502)

location_facility: Kirovograd Regional oncology Dispensary ( Site 1716)

location_facility: Skanes Universitetssjukhus Lund. ( Site 2001)

location_facility: Vaal Triangle Oncology Centre ( Site 1905)

location_facility: Hospital Britanico de Buenos Aires ( Site 2705)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1704)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0802)

location_facility: Pan American Center for Oncology Trials LLC ( Site 0501)

location_facility: Parkland Health & Hospital System ( Site 0091)

location_facility: Riga East Clinical University Hospital ( Site 2103)

location_facility: Norton Cancer Institute - St. Matthews ( Site 0024)

location_facility: Seoul National University Bundang Hospital ( Site 2403)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0801)

location_facility: Hospital Nacional Daniel Alcides Carrion ( Site 3207)

title: A Phase 2 Study of Olaparib in Combination With Pembrolizumab in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer

location_country:
Germany
Poland
Argentina
Australia
Japan
Turkey
Canada
France
Colombia
United States
Latvia
Ukraine
Romania
Peru
Puerto Rico
Italy
Guatemala
Sweden
Mexico
Korea, Republic of
Spain
South Africa
Israel


title: A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis

acronym: RAISE

summary: The RAISE study is a multicenter, randomized, double-blind, placebo controlled study to confirm the efficacy, safety, and tolerability of zilucoplan in subjects with generalized Myasthenia Gravis. Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or placebo for 12 weeks.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Howard JF Jr, Bresch S, Genge A, Hewamadduma C, Hinton J, Hussain Y, Juntas-Morales R, Kaminski HJ, Maniaol A, Mantegazza R, Masuda M, Sivakumar K, Smilowski M, Utsugisawa K, Vu T, Weiss MD, Zajda M, Boroojerdi B, Brock M, de la Borderie G, Duda PW, Lowcock R, Vanderkelen M, Leite MI; RAISE Study Team. Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Neurol. 2023 May;22(5):395-406. doi: 10.1016/S1474-4422(23)00080-7.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ipd_sharing: Yes

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

lead_sponsor: Ra Pharmaceuticals, Inc.

location_country:
Germany
Italy
Poland
Norway
United Kingdom
Japan
United States
Spain
Canada
France

location_facility: Site 191: Centre Hosptitalier Universitaire d'Angers

location_facility: Site 134: Neurology and Sleep Disorders Clinic

location_facility: Site 119: Oxford University Hospitals NHS Foundation Trust

location_facility: Site 195: Wielospecjalistyczna Poradnia Lekarska Synapsis

location_facility: Site 31: University of California Irvine

location_facility: Site 205: Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz

location_facility: Site 156: University of Kansas Medical Center

location_facility: Site 45: Center for Neurological Disorders

location_facility: Site 19: University of Texas Southwestern

location_facility: Site 156: Indiana University Health Neuroscience Center

location_facility: Site 179: Kagawa University Hospital - Collagen disease/Rheumatic int

location_facility: Site 169: International University of Health and Welfare Narita Hospital

location_facility: Site 188: North Shore Medical Group - Glenview

location_facility: Site 132: Università Cattolica del Sacro Cuore - Campus di Milano

location_facility: Site 128: Medical University of South Carolina

location_facility: Site 11: Montreal Neurological Institute and Hospital (McGill University)

location_facility: Site 135: Augusta University Medical Center

location_facility: Site 211: Specjalistyczne Gabinety Sp. z o.o.

location_facility: Site 138: Hospital Universitario de Basurto

location_facility: Site 164: University of Virginia Health System

location_facility: Site 194: Twoja Przychodnia - Centrum Medyczne Nowa Sól

location_facility: Site 105: Pitié-Salpêtrière University Hospital

location_facility: Site 123: Northwell Health Neuroscience Institute

location_facility: Site 213: Niepubliczny Zakład Opieki Zdrowotnej NOVO-MED

location_facility: Site 33: Detroit medical Center - University Health Center

location_facility: Site 160: Forbes Norris MDA/ALS Research and Treatment Center

location_facility: Site 4: University of Southern California

location_facility: Site 153: Toho University Ohashi Medical Center

location_facility: Site 221: Neurology Center of New England

location_facility: Site 126: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Site 168: Hospital de la Santa Creu i Sant Pau

location_facility: Site 137: Les Hôpitaux Universitaires de Strasbourg

location_facility: Site 116: Neuromuscular Clinic and Research Center

location_facility: Site 192: Krakowski Szpital Specjalistyczny im. Jana Pawła II

location_facility: Site 44: London Health Sciences Centre University Hospital

location_facility: Site 193: Krakowska Akademia Neurologii - Centrum Neurologii Kliniczne

location_facility: Site 133: Hospital Universitari Vall d'Hebrón

location_facility: Site 163: Tokyo Medical University Hospital

location_facility: Site 40: Allegheny Neurological Associates

location_facility: Site 204: Centre Hospitalier Régional Universitaire de Lille

location_facility: Site 209: Niepubliczny Zakład Opieki Zdrowotnej NEURO - KARD

location_facility: Site 32: Kansas University Medical Center Research Institute

location_facility: Site 201: Centrum Medyczne Pratia - Warszawa

location_facility: Site 140: Haukeland University Hospital / Health Bergen

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 1/2 Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas

summary: First-in-human, open-label, sequential dose escalation and expansion study of CPI-0209 in patients with advanced solid tumors and lymphomas. CPI-0209 is a small molecule inhibitor of EZH2.

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Constellation Pharmaceuticals

location_country:
Italy
Poland
United Kingdom
United States
Spain
France

location_facility: University of Maryland - Marlene and Stewart Greenebaum Cancer Center

location_facility: Strasbourg Europe Institut of Cancerology

location_facility: Nantes University Hospital Center - Hotel Dieu Hospital (Satellite)

location_facility: Weill Medical College of Cornell University

location_facility: Gruppo Humanitas - Humanitas Research Hospital - Cancer Center

location_facility: University Hospitals of Leicester NHS Trust

location_facility: South Texas Accelerated Research Therapeutics (Start) - Midwest Location

location_facility: NYU Langone Medical Center - Laura and Isaac Perlmutter Cancer Center

location_facility: Winship Cancer Institute of Emory University

location_facility: Montefiore Einstein Center for Cancer Care

location_facility: University Clinical Hospital of Salamanca

location_facility: Maria Sklodowska-Curie - National Research Institute of Oncology

status_simplified: Ongoing


title: A Phase II Open-label Multicenter Study to Assess the Efficacy and Safety of AFM13 in Patients With Relapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides (REDIRECT)

acronym: REDIRECT

summary:
This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as monotherapy in patients with CD30-positive T-cell lymphoma. The investigational medicinal product AFM13 is a tetravalent bispecific chimeric (anti-human CD30 x anti-human CD16A) recombinant antibody construct which is being developed to treat CD30-positive malignancies.

Patients who suffer from peripheral T-cell lymphoma or transformed mycosis fungoides, whose tumor expresses the surface marker CD30, and who have relapsed after an earlier treatment or have refractory disease will be enrolled into this study if all of the study entry criteria are fulfilled. Dependent on their disease type and the magnitude of CD30 expression, study participants will be assigned to one of 3 study cohorts, each cohort receiving the same treatment of weekly AFM13 infusions (a 200mg dose per infusion).

The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate of overall responses. Further goals are to assess the safety of AFM13 treatment, the immunogenicity of AFM13 (as measured by the potential formation of anti-AFM13 antibodies) and the concentration of AFM13 in the blood.

Approx. 1 month after the last dose of AFM13 there will be a final study visit to assess the patients' health status after therapy, followed by quarterly phone contacts to check on their overall health status and long-term survival.

status: Active, not recruiting

lead_sponsor: Affimed GmbH

location_country:
Germany
Italy
Poland
Australia
United States
Korea, Republic of
Spain
Turkey
Russian Federation
France

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Ist.Ematologia E Oncologia Medica L.E A.Seragnoli

location_facility: Ankara University Faculty of Medicine, Department of Internal Diseases, Hematology Division

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim Arastirma Hastanesi Hematoloji Klinigi Ankara

location_facility: Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırm Hastanesi

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

location_facility: Abramson Cancer Center of the University of Pennsylvania

location_facility: Instytut Hematologii i Transfuzjologii, Klinika Hematologii

location_facility: Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol

location_facility: Kocaeli University Faculty of Medicine, Department of Internal Diseases, Hematology Division

location_facility: Gazi University Faculty of Medicine, Department of Internal Diseases

location_facility: Ochsner Clinic Foundation/Precision Cancer Therapies Program

location_facility: Kliniken Essen Sued - Evangelisches Krankenhaus Essen-Werden gGmbH

location_facility: Emory University Clinic/Winship Cancer Institute

location_facility: University of California Los Angeles (UCLA) Health

location_facility: First State Saint-Petersburg Pavlov Medical University

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu. Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku

location_facility: GUZ Leningrad Regional Clinical Hospital

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uyg. ve Egitim Merkezi

location_facility: KaradenizTeknik Universitesi Tip Fakultesi Farabi Hastanesi

location_facility: Seoul National University Bundang Hospital

location_facility: Duran I Reynals Hospital Catalan Institute Of Oncology

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

location_facility: Szpitale Pomorskie Sp. z o.o.. Szpital Morski im. PCK, Oddzial Hematologii i Transplantologii Szpiku

location_facility: Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency

location_facility: Tekirdag Namik Kemal Universitesi Saglik Uygulama ve Arastirma Hastanesi

location_facility: Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Ic Hastaliklari Anabilim Dali Hematoloji Bilim Dali Fatih

location_facility: Azienda Unita Sanitaria Locale di Ravenna - Ospedale S. Maria delle Croci di Ravenna

location_facility: University of Michigan Health | Rogel Cancer Center

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux

location_facility: University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego

location_facility: City of Hope Comprehensive Cancer Center


title: Benefits of Microcor in Ambulatory Decompensated Heart Failure

acronym: BMAD-TX

summary: To assess investigator engagement of μCor system data in the context of heart failure management. The μCor system includes a sensor and wearable patch for fluid management.

primary_purpose: Diagnostic

lead_sponsor: Zoll Medical Corporation

location_country:
United States
Germany
Austria
France

location_facility: Accel Research Sites - Lake County Medical Group

location_facility: BronxCare Health System at BronxCare Hospital Center

location_facility: Accel Research Sites - Guardian Winter Park

location_facility: Chu Montpellier - Hopital Arnaud de Villeneuve

location_facility: Sinai Center for Thrombosis Reserach and Drug Development

location_facility: Accel Research Sites- Daytona Heart Group

location_facility: Winter Haven Hospital - BayCare Health System

location_facility: Methodist Physicians Clinical Heart Consultants

location_facility: CHU Montpellier - Hopital Arnaud de Villeneuve

location_facility: Westchester Research Center at Westchester General Hospital

location_facility: Mercer Bucks Cardiology at Jefferson Health

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Cardiologique

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Herzzentrum Leipzig, Universitätsklinik für Kardiologie Abteilung Rhythmologie

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Macklenberg Heart Specialists / Focus Clinical Research Solutions

location_facility: Gateway Cardiovascular Research Center, Inc

location_facility: Holy Cross Hospital, Medical Group, Cardiology Associates

location_facility: Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5

location_facility: Cardiovascular Research of Northwest Indiana, LLC

intervention_type: Device


intervention_type: Genetic

lead_sponsor: Spark Therapeutics

summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy of a single intravenous infusion of SPK-3006 in adults with clinically moderate, late-onset Pompe disease receiving enzyme replacement therapy (ERT). Participants will be treated in sequential, dose-level cohorts.

location_facility: CHU Paris IdF Ouest - Hôpital Raymond Poincaré

location_facility: Universita Degli Studi Di Milano, Laboratorio di Biochimica e Genetica della Malattie Neuromuscolari

location_facility: Friedrich-Baur-Institut Neurologische Klinik Ludwig-Maximilians-Universität München

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: University of Kansas Medical Center Research Institute

location_facility: Universita Degli Studi Di Messina - Dipartimento di Medicina Clinica e Sperimentale

location_facility: Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino - Neurology, Osp. Molinette

location_facility: Assistance Publique Hôpitaux de Marseille

location_facility: UO Neurologia Azienda Ospedaliera Universitaria Pisana

location_facility: Malattie Metaboliche Universita Degli Studi Di Napoli Federico II

location_facility: The Royal Free London NHS Foundation Trust

location_facility: Lysosomal and Rare Disorders Research & Treatment Center

location_facility: Centre Hospitalier Universitaire d'Angers

title: Phase 1/2, Dose-escalation Study to Evaluate the Safety, Tolerability and Efficacy of a Single Intravenous Infusion of SPK-3006 in Adults With Late-onset Pompe Disease

type: EudraCT Number

source: euctr

location_country:
Germany
Italy
United Kingdom
Denmark
Netherlands
United States
Canada
France


type: Other Identifier

type: Registry Identifier

title: Efficacy and Safety of Concizumab Prophylaxis in Patients With Haemophilia A or B Without Inhibitors

summary: This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B without inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group participants will get study medicine from the start of the study. In the other group participants will continue with their normal medicine and get study medicine after 6 months. Which treatment the participant gets is decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will have to inject themselves with the study medicine 1 time every day under the skin. This can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for up to 6.5 years. The length of time the participant will be in the study depends on when they agreed to take part or when the medicine is available for purchase in their country (21 April 2026 at the latest). Participants will have to come to the clinic for up to 40 times. The time between visits will be approximately 4 weeks for the first 6 to 12 months depending on the group participants are in, and approximately 8 weeks for the rest of the study. If the participant attends extra visits due to the prescription medicine not being available for purchase in their country, these will be 14 weeks apart. Participants will be asked to record information in an electronic diary during the study and may also be asked to wear an activity tracker.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
Poland
Algeria
Australia
Japan
Bosnia and Herzegovina
Thailand
Turkey
Croatia
Canada
Serbia
France
Lithuania
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Ukraine
India
Malaysia
Estonia
Italy
United Kingdom
Sweden
Mexico
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation
Israel


acronym: 1L BTC Phase II/III Gemcitabine Plus Cisplatin With or Without M7824

lead_sponsor: EMD Serono Research & Development Institute, Inc.

summary: Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic Biliary Tract Cancer (BTC) compared to placebo, gemcitabine and cisplatin.

ReferenceCitation: Yoo C, Oh DY, Choi HJ, Kudo M, Ueno M, Kondo S, Chen LT, Osada M, Helwig C, Dussault I, Ikeda M. Phase I study of bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1, in patients with pretreated biliary tract cancer. J Immunother Cancer. 2020 May;8(1):e000564. doi: 10.1136/jitc-2020-000564.

oa_colors: green gold

oa_host_type: publisher;repository

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Yonsei University Medical Library - YUHSpace

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central;ir.ymlib.yonsei.ac.kr

publisher_dissemination: British Medical Journal

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centre Georges François Leclerc - Oncologie Médicale

location_facility: Chungnam National University Hospital - Department of Internal Medicine (Rheumatology)

location_facility: Instituto Clinico Oncologico del Sur (ICOS)

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo

location_facility: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

location_facility: Cancer Institute Hospital of JFCR - Dept of Hepato,Biliary and Pancreatic Medicine

location_facility: Fudan University Shanghai Cancer Hospital

location_facility: Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

location_facility: National Cancer Center Hospital - Dept of Hepatobiliary and Pancreatic Oncology

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori Milano

location_facility: Hospital Universitari Vall d'Hebron - Dept of Oncology

location_facility: Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia

location_facility: Hospital Universitario Clinico San Carlos - Servicio de Oncologia

location_facility: Mayo Clinic in Florida - Department of Neurology

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

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - Medizinische Klinik I - HCC Ambulanz

location_facility: IOV - Istituto Oncologico Veneto IRCCS - S.Semplice Dip.Oncologia dei Melanomi

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I

location_facility: Centro de Investigación Clínica Bradford Hill

location_facility: ICO - Site Paul Papin - service d'oncologie medicale

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica

location_facility: Seoul National University Bundang Hospital

location_facility: NHO Kyushu Cancer Center - Dept of Gastroenterology/Hepatology/Pancreatology

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Universitaetsklinikum Bonn AoeR - Medizinische Klinik I Gastroenterologie

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Ironwood Cancer & Research Centers - Chandler II

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

location_facility: Hospital San Pedro de Alcantara - Servicio de Oncologia

location_facility: University of Kansas Medical Center Research Institute, Inc. - University of Kansas Cancer Center/Bloch Pavilion

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica

location_facility: Hospital Universitario Reina Sofia - Dept of Oncology

location_facility: Instituto de Investigaciones Metabolicas (IDIM)

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: Vivantes Klinikum Neukoelln - Haematologie und Onkologie

location_facility: Sidney Kimmel Comprehensive Cancer Center at John Hopkins

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

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia

location_facility: Centrum Onkologii-Instytut im.M.Sklodowskiej Curie

status: Terminated

title: A Phase II/III, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) as First-line Treatment of Biliary Tract Cancer

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Australia
Brazil
Japan
United States
China
Korea, Republic of
Spain
Chile
Taiwan
France

status_simplified: Unknown


title: An Open Label Randomized Phase 2 Trial of Amcenestrant (SAR439859), Versus Endocrine Monotherapy as Per Physician's Choice in Patients With Estrogen Receptor-positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer With Prior Exposure to Hormonal Therapies

summary:
Primary Objective:

To determine whether amcenestrant per overall survival (os) improves progression free survival (PFS) when compared with an endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer

Secondary Objectives:

To compare the overall survival in the 2 treatment arms
To assess the objective response rate in the 2 treatment arms
To evaluate the disease control rate in the 2 treatment arms
To evaluate the clinical benefit rate in the 2 treatment arms
To evaluate the duration of response in the 2 treatment arms
To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms
To evaluate the pharmacokinetics of amcenestrant as single agent
To evaluate health-related quality of life in the 2 treatment arms
To compare the overall safety profile in the 2 treatment arms

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

lead_sponsor: Sanofi

location_country:
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
United States
Latvia
Ukraine
Belgium
China
Puerto Rico
Italy
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

location_facility: Dartmouth Hitchcock Med Center Site Number : 8400013

location_facility: Northwest Medical Specialties Site Number : 8400038

location_facility: University Of Vermont Site Number : 8400026

location_facility: Torre Hospital Auxilo Mutuo Site Number : 8400028

location_facility: The University of Kansas Clinical Research Center Site Number : 8400027

location_facility: Dana Farber Cancer Institute Site Number : 8400015

location_facility: University of Wisconsin Site Number : 8400016

location_facility: Hackensack University Medical Center Site Number : 8400025

location_facility: Saint Luke's Hospital Site Number : 8400032

location_facility: Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo Site Number : 0760006

location_facility: The Center For Cancer And Blood Disorders Site Number : 8400022

location_facility: UCLA Hematology Oncology Parkside Site Number : 8400024

location_facility: Hospital de Base Sao Jose do Rio Preto Site Number : 0760003

location_facility: Hematology Oncology Clinic Site Number : 8400020

location_facility: Gabrail Cancer Center Site Number : 8400006

location_facility: Hospital Araujo Jorge Site Number : 0760005

location_facility: Hospital Mae de Deus Site Number : 0760002

location_facility: Comprehensive Blood and Cancer Center Site Number : 8400018

location_facility: Hospital de Clinicas de Porto Alegre - HCPA Site Number : 0760001


lead_sponsor: Boehringer Ingelheim

summary: The primary objective of this trial is to assess the efficacy, safety and pharmacokinetics of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler versus placebo in adolescents and adult patients with cystic fibrosis.

ReferenceType: derived

ReferenceCitation: Goss CH, Fajac I, Jain R, Seibold W, Gupta A, Hsu MC, Sutharsan S, Davies JC, Mall MA. Efficacy and safety of inhaled ENaC inhibitor BI 1265162 in patients with cystic fibrosis: BALANCE-CF 1, a randomised, phase II study. Eur Respir J. 2022 Feb 17;59(2):2100746. doi: 10.1183/13993003.00746-2021. Print 2022 Feb.

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: Imperial College London - Spiral

repositories_concat: PubMed Central;spiral.imperial.ac.uk

unpaywall_oa_status: hybrid

publisher_dissemination: European Respiratory Society

ReferenceCitation: Goss CH, Jain R, Seibold W, Picard AC, Hsu MC, Gupta A, Fajac I. An innovative phase II trial to establish proof of efficacy and optimal dose of a new inhaled epithelial sodium channel inhibitor BI 1265162 in adults and adolescents with cystic fibrosis: BALANCE-CFTM 1. ERJ Open Res. 2020 Dec 7;6(4):00395-2020. doi: 10.1183/23120541.00395-2020. eCollection 2020 Oct.

repositories_concat: PubMed Central

location_facility: Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Riley Hospital for Children at Indiana University Health

location_facility: Virginia Commonwealth University Health Systems

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Stockholm CF-Center , B59, Huddinge Universitetssjukhus

location_facility: The University of North Carolina at Chapel Hill

location_facility: University of Texas Southwestern Medical Center

title: A Randomised, Double-blind, Placebo-controlled and Parallel Group Trial to Evaluate Efficacy and Safety of Twice Daily Inhaled Doses of BI 1265162 Delivered by Respimat® Inhaler as add-on Therapy to Standard of Care Over 4 Weeks in Patients With Cystic Fibrosis - BALANCE - CF™ 1

ipd_sharing_description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer-ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

location_country:
Germany
United Kingdom
Sweden
Belgium
United States
Spain
Canada
France


title: An Open-label, Multi-center Rollover Protocol for Continued Characterization of Safety and Tolerability for Subjects Who Have Participated in a Novartis-sponsored Spartalizumab Study as Single Agent or in Combination With Other Study Treatments

summary: The purpose of this study is to continue to assess safety and tolerability, and to allow continued access to study treatment for subjects already receiving spartalizumab as single agent or in combination with other study treatments.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Poland
Hungary
Hong Kong
Netherlands
Switzerland
Belgium
United States
China
Korea, Republic of
Spain
Thailand
Taiwan
Czechia
Canada
France

location_facility: MD Anderson Cancer Center/University of Texas MDACC

location_facility: Columbia University Medical Center- New York Presbyterian


title: A Multicenter, Noninterventional, Prospective Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Moderate to Severe Plaque Psoriasis in Daily Practice

acronym: CIMREAL

summary: The purpose of the study is to assess the effectiveness of certolizumab pegol in patients with moderate to severe plaque psoriasis as part of routine clinical practice.

study_type: Observational

time_perspective: Prospective

ipd_sharing_description: Data from non-interventional studies is outside of UCB's data sharing policy and is unavailable for sharing.

lead_sponsor: UCB Biopharma SRL

location_country:
Germany
Italy
United Kingdom
Belgium
Spain
Greece
Czechia
Canada
France


title: A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients With High Risk RetroPeritoneal Sarcoma (RPS)

summary:
This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival.

After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

collaborators: Australia and New Zealand Sarcoma Association

location_country:
Germany
Italy
Cyprus
Poland
Slovakia
United Kingdom
Denmark
Australia
Japan
Netherlands
United States
Spain
Czechia
Canada
France

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol

location_facility: UCHealth University of Colorado Hospital

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: Princess Alexandra Hospital - University Of Queensland

location_facility: Sanford USD Medical Center - Sioux Falls

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: VCU Massey Cancer Center at Hanover Medical Park

location_facility: Aarhus University Hospitals - Aarhus University Hospital-Skejby

location_facility: University of Kansas Cancer Center-Overland Park

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: Saitama Medical Center, Jichi Medical University

location_facility: Leeds Teaching Hospitals NHS Trust - St. James's University Hospital

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Universitaetsmedizin Goettingen - Georg-August Universitaet

location_facility: University of Oklahoma Health Sciences Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University of Kansas Hospital-Westwood Cancer Ctr

location_facility: IRCCS - Fondazione Piemonte Inst di Candiolo

location_facility: IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

location_facility: Hopitaux Universitaires de Strasbourg - Hautepierre

location_facility: Newcastle Hospitals - Freeman Hospital, Northern Centre For Cancer Care

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Moffitt Cancer Center-International Plaza

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Niigata University Medical and Dental Hospital

location_facility: UC Irvine Health/Chao Family Comprehensive Ca Ctr

location_facility: Washington University School of Medicine - Siteman Cancer Center

location_facility: University Hospitals Birmingham - Queen Elisabeth Medical Centre

location_facility: Chris O'Brian Life House - Chris O'Brien Lifehouse

location_facility: Policlinico Universitario Campus Bio-Medico- Oncology Center

location_facility: Radboudumc - Radboud University Medical Center Nijmegen

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology

location_facility: Virginia Commonwealth Univ/Massey Cancer Center

intervention_type: Procedure


title: An Open-label Phase 1b Study of E7386 in Combination With Other Anticancer Drug(s) in Subjects With Solid Tumors

summary: The primary objective of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s).

ipd_sharing_description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

lead_sponsor: Eisai Inc.

location_country:
Japan
United States
Korea, Republic of
Taiwan
France

location_facility: Centre Hospitalier Universitaire de Bordeaux (CHU Bordeaux)(Hopitaux de Bordeaux) - Groupe hospitalier Sud - Hopital Haut-Levequ

location_facility: UCLA University of California - Los Angeles

location_facility: Chang Gung Medical Foundation - Kaohsiung Branch

location_facility: University of California San Diego (UCSD) - Moores Cancer Center(All)

location_facility: Chang Gung Medical Foundation - Linkou Branch

location_facility: University of Texas Southwestern Medical

location_facility: University of Colorado Cancer Center - Anschutz Medical Campus

location_facility: Hepatology, Hopital de la Croix-Rousse - 103 grande rue de la Croix-Rousse

location_facility: Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville

location_facility: University of Oklahoma Health Science Center


title: A Phase 1/2, Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

summary: The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_country:
Germany
Italy
Denmark
United States
Spain
Greece
Czechia
Canada
France

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: Dana-Farber/Mass General Brigham Cancer Care, Inc

location_facility: Winship Cancer Institute of Emory University


summary: Semaglutide is a medicine studied in patients with non-alcoholic steatohepatitis (NASH), as it may improve liver damage. Participants will either get semaglutide or placebo (a dummy medicine) - which treatment participants get is decided by chance. The study will last for about 61 weeks in total. Participants will have 10 clinic visits and 3 phone calls with the study doctor or staff during the study. Some of the clinic visits may be spread over more days. Participants will need to inject themselves with medicine under the skin. Participants will have to do this once a week for 48 weeks. The study includes magnetic resonance imaging (MRI) scans of the liver, 1 or 2 liver tissue samples, ultrasound scans of the stomach and a possible examination of the food pipe. For some tests participants may need to remove some items of clothing. Participants will stop in the study if the doctor thinks that there are any risks for their health. The information collected from participants during the study may help them and other patients with NASH in the future. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

ReferenceType: background

ReferenceCitation: Loomba R, Abdelmalek MF, Armstrong MJ, Jara M, Kjaer MS, Krarup N, Lawitz E, Ratziu V, Sanyal AJ, Schattenberg JM, Newsome PN; NN9931-4492 investigators. Semaglutide 2.4 mg once weekly in patients with non-alcoholic steatohepatitis-related cirrhosis: a randomised, placebo-controlled phase 2 trial. Lancet Gastroenterol Hepatol. 2023 Jun;8(6):511-522. doi: 10.1016/S2468-1253(23)00068-7. Epub 2023 Mar 16.

title: Investigation of Efficacy and Safety of Semaglutide s.c. Once-weekly Versus Placebo in Subjects With Non-alcoholic Steatohepatitis and Compensated Liver Cirrhosis

location_country:
Germany
United Kingdom
United States
Spain
France


title: A Phase 2, Multicenter, Randomized, Double-Blind, Active-Control Study to Evaluate the Efficacy and Safety of Nivolumab Administered in Combination With IPI-549 Compared to Nivolumab Monotherapy in the Treatment of Patients With Immune Therapy-Naïve, Advanced Urothelial Carcinoma

summary: The purpose of this study is to measure the effect of IPI-549 in combination with nivolumab when compared to nivolumab monotherapy in advanced urothelial cancer patients.

lead_sponsor: Infinity Pharmaceuticals, Inc.

sponsor_collaborators:
Infinity Pharmaceuticals, Inc.
Bristol-Myers Squibb

location_country:
Italy
Poland
United States
Spain
Czechia
Serbia
France

location_facility: Oddzial Chorob Rozrostowych Wojewodzki Szpital

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

location_facility: Istituto per la Ricerca e la Cura del Cancro (IRCC)

location_facility: University of MD - Greenebaum Comprehensive Cancer Center

location_facility: Hospital Universitario Central de Asturias


lead_sponsor: Advanced Accelerator Applications

summary: The aim of NETTER-2 is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients are eligible, as well as patients previously treated with SSAs in the absence of progression.

ReferenceCitation: Jungels C, Deleporte A. State of the art and future directions in the systemic treatment of neuroendocrine neoplasms. Curr Opin Oncol. 2021 Jul 1;33(4):378-385. doi: 10.1097/CCO.0000000000000740.

publisher_dissemination: Wolters Kluwer Health

location_facility: Institut du Cancer de Montpellier - Oncology

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: USF - H. Lee Moffitt Cancer Center and Research Institute

location_facility: Severance Hospital, Yonsei University Health System - Medical Oncology

location_facility: CHU-Hôtel Dieu Service de Médecine Nucléaire

location_facility: Arcispedale Santa Maria Nuova, Reggio Emilia - Oncology

location_facility: Universitätsklinikum Essen - Klinik für Nuklearmedizin

location_facility: Azienda Ospedaliera Sant'Andrea - Università La Sapienza U.O.C. Mal App. Digerente e - Oncology

location_facility: Complejo Hospitalario Universitario Santiago de Compostela

location_facility: Seoul National University Hospital - Department of Internal Medicine

location_facility: Centre Hospitalier Universitaire de Quebec

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: University of Kentucky UK Markey Cancer Center

location_facility: Fondazione Irccs Istituto Nazionale Tumori

location_facility: London Health Sciences Centre, University of Western Ontario - Oncology

location_facility: Hospices Civils de Lyon (HCL) - Hopital Edouard Herriot

location_facility: University of Iowa Hospitals and Clinics - Oncology

title: A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET

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

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

location_country:
Germany
Italy
United Kingdom
Netherlands
United States
Korea, Republic of
Spain
Canada
France


lead_sponsor: Biogen

summary: This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study.

location_facility: General Hospital of Thessaloniki 'Hippokration'

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: SBIH of Moscow region "Moscow Regional Scientific & Research

location_facility: Mother and Child Health Care Institute of Serbia ''Dr Vukan Cupic''

location_facility: Azienda Ospedaliera Universitaria 'Federico II'

location_facility: Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António

location_facility: Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

location_facility: Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospital Pediátrico

location_facility: SAIH 'Kemerovo Regional Clinical Hospital'

location_facility: SBEI HPE 'Rostov State Medical University' of the MoH of the RF

location_facility: RSBIH 'Belgorod Regional Clinical Hospital of Saint Ioasaf'

location_facility: Centro Hospitalar e Universitário Lisboa Norte E.P.E.

location_facility: Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: SBEI HPE 'Bashkir State Medical University' of the MoH of the RF

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: LLC National center for socially significan disease

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"

location_facility: FSBI "Federal Siberian Scientific-Clinical Center of FMBA"

location_facility: Clinic of Neurology and Psychiatry for Children and Youth

location_facility: Gazi University Medical Faculty Clinical Research Unit

location_facility: State Budgetary Institution of Healthcare of Yaroslavl region 'Clinical Hospital # 2'

title: An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

location_country:
Germany
Argentina
Australia
Kuwait
Turkey
Croatia
Czechia
Serbia
France
Portugal
Slovakia
Hungary
United States
Tunisia
Belgium
Italy
Saudi Arabia
Spain
Greece
Bulgaria
Russian Federation
Israel


acronym: M-STAR

lead_sponsor: Biohaven Pharmaceuticals, Inc.

summary: The purpose of this study is to compare the efficacy of verdiperstat (BHV-3241) versus placebo in participants with Multiple System Atrophy

ReferenceCitation: Schmahmann JD, Pierce S, MacMore J, L'Italien GJ. Development and Validation of a Patient-Reported Outcome Measure of Ataxia. Mov Disord. 2021 Oct;36(10):2367-2377. doi: 10.1002/mds.28670. Epub 2021 Jun 11.

publisher_dissemination: Wiley

location_facility: Klinik für Neurologie - UKSH - Campus Kiel

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Campus for Ageing and Vitality (NGH)

location_facility: Universitaetsklinikum Giessen und Marburg GmbH - Parkinson-Studienzentrum, Klinik für Neurologie

location_facility: Parkinson's Disease and Movement Disorders Center at the University of Pennsylvania

location_facility: Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes

location_facility: NYU School of Medicine, NYU Dysautonomia Center

location_facility: St. Josef - Hospital Bochum, Kardiologische Studienambulanz

location_facility: UCLA Medical Center / Neurological Services

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: Unité d'investigation clinique de Neurologie Rez-de-jardin, Bloc Hopital CHU Pontchaillou

location_facility: UC San Diego Department of Neurosciences

location_facility: Confraternitaet Privatklinik Josefstadt in Wien

location_facility: Columbia University Medical Center, Neurological Institute

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

location_facility: Pennsylvania State University Hershey Medical Center

location_facility: Rocky Mountain Movement Disorders Center

location_facility: A.O.U. San Giovanni di Dio e Ruggi d'Aragona

location_facility: CRC Core Facility Medizinische Hochschule Hannover (MHH)

location_facility: Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)

title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects With Multiple System Atrophy (M-STAR Study)

location_country:
Germany
Italy
United Kingdom
Austria
United States
France


acronym: ELEVATE UC 52

lead_sponsor: Arena Pharmaceuticals

summary: The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: Texas Digestive Disease Consultants - San Marcos

location_facility: Clinic for Internal Medicine I, University hospital Schleswig-Holstein, Campus Kiel

location_facility: San Diego Gastroenterology Medical Associates

location_facility: Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz

location_facility: SPb SBIH "City Hospital # 40 of Kurortnyi region"

location_facility: UMHAT "Sv. Ivan Rilski", EAD,Clinic of gastroenterology

location_facility: Saint George University Hospital Medical Center

location_facility: P. Stradins Clinical University Hospital

location_facility: Gastromed Kralisz, Romatowski, Stachurska sp.j

location_facility: Vitebsk Regional Clinical Specialized Center

location_facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca

location_facility: 1th Dept of Gastroenterology, Szent Gyorgy Hospital

location_facility: Diagnostic-Consultative Center I - Sliven, EOOD

location_facility: Spedali Civili di Brescia, U.O. Gastroenterologia

location_facility: Department of Propaedeutics of Internal Medicine Ivano-Frankivsk National Medical University

location_facility: SZTE AOK I.st dept. of Internal Medicine.

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Stavropol Regional Clinical Diagnostic Centre

location_facility: Belfast Health and Social Care Trust Royal Victoria Hospital

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: Barts Health NHS Trust - Whipps Cross University Hospital

location_facility: Diagnostic Consultation Center CONVEX EOOD

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: LTD Israeli-Georgian Medical Research clinic Helsicore

location_facility: Irkutsk State Medical Academy of Continuing Education

location_facility: Biopharma Informatic, Inc. Research Center

location_facility: West Central Gastroenterology d/b/a Gastro Florida

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

location_facility: Medical Center Nov Rehabilitatsionen Tsentar EOOD

location_facility: State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko"

location_facility: Klaipeda University Hospital, Department of Gastroenterology

location_facility: I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

location_facility: SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU

location_facility: Medical College of Wisconsin Clinical Trials Office

location_facility: Marshall University Department of Clinical Research

location_facility: Postgraduate department of Medicine, GSVM Medical college

location_facility: EMC INSTYTUT MEDYCZNY SA, EuroMediCare Szpital Specjalistyczny z Przychodnia - Dzial Farmacji

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

location_facility: Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna

location_facility: Zuyderland Medisch Centrum - Sittard-Geleen

location_facility: General Hospital "Dr.Tomislav Bardek" Koprivnica

location_facility: LTD Central University Clinic After Academic N. Kipshidze

location_facility: Communal Non-Commercial Enterprise Lviv Clinical Hospital of Emergency Medical Care

location_facility: UAB "Inlita", Santaros Clinical Trials Centre

location_facility: Communal Non-Commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council

location_facility: Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia

location_facility: Health Care Institution "10th City Clinical Hospital"

location_facility: LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine

location_facility: Republican Panevezys Hospital, Department of Gastroenterology

location_facility: Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica

location_facility: JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

location_facility: ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD,Clinical Research Center

location_facility: Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University"

location_facility: Allmedica Badania Kliniczne Sp. z o.o. Sp.k.

location_facility: National Military Medical Clinical Center Main Military Clinical Hospital

location_facility: Medical Clinical Investigational Center of Medical Center Health Clinic LLC

location_facility: SBIH of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"

location_facility: Institution "Gomel Regional Clinical Hospital"

location_facility: Municipal non-profit enterprise "Regional Clinical Hospital of Ivano-Frankivsk Regional Council", Ga

location_facility: Clinical Center " Dr Dragisa Misovic Dedinje"

location_facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

location_facility: Centralny Szpital Kliniczny MSW w Warszawie

location_facility: Kocaeli University Research and Training Hospital

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

location_facility: Digestive Health Specialists of the Southeast

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

location_facility: Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology

location_facility: West Hertfordshire Hospitals NHS Trust Hemel Hempstead General Hospital

location_facility: Kremenchuk first city hospital n.a. O.T. Bohaievskyi

location_facility: SAIH "Kemerovo Regional Clinical Hospital

location_facility: Duke University Medical Center GI Clinical Research Unit

location_facility: Timofei Mosneaga Republican Clinical Hospital, Department of Gastroenterology

location_facility: Karkonoskie Centrum Badan Klinicznych Lexmedica

location_facility: Bekes Megyei Kozpont Korhaz Dr Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia

location_facility: UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center, next to the chimney

location_facility: Acibadem City Clinic University Hospital EOOD

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada s.c.

location_facility: Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City Clinical Hospital of Kherson City

location_facility: Odesa regional clinical hospital, regional center of gastroenterology, surgical department

location_facility: RTL SM SRL, Institutia Medico-Sanitara Publica Spitalul Clinic, Sectia Proctologie

location_facility: Aalborg University Hospital, department of medical gastroenterology

location_facility: Austin Health Gastroenterology Department

location_facility: Clinical Hospital of the Ministry of Health, Labor and Social Protection

location_facility: LLC "Multidisciplinary Medical Clinic "Anthurium"

location_facility: Communal Institution City Clinical Hospital #6, Department of Gastroenterology

location_facility: Dr. Carol Davila Central University Emergency Military Hospital

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD

location_facility: Fundación Respirar- Centro Médico Dra. De Salvo

location_facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Private Educational Institution of Higher Education "Medical University REAVIZ"

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

location_country:
Germany
Poland
Argentina
Australia
Thailand
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Belarus
Lithuania
Portugal
Slovakia
Hungary
Denmark
United States
Latvia
Ukraine
India
Romania
Lebanon
Belgium
Moldova, Republic of
Estonia
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Georgia
Russian Federation
Israel


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Participants With Sarcoidosis-Associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag.

acronym: SPHINX

summary: Oral selexipag is commercially available in several countries for the treatment of a particular group of pulmonary hypertension (PH) called pulmonary arterial hypertension (PAH). The aim of the present study is to investigate whether selexipag could be helpful to treat patients with another form of PH called sarcoidosis-associated pulmonary hypertension (SAPH).

ipd_sharing_description:
Actelion is a Janssen pharmaceutical company of Johnson & Johnson. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Actelion

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

location_facility: RBK Lungenzentrum Stuttgart am Robert-Bosch-Krankenhaus

location_facility: Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: A.O.U. Città della Salute e della Scienza

location_facility: Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes

location_facility: Medical University of South Carolina (MUSC) - College of Medicine (COM)

location_facility: Universitatsklinikum Carl Gustav Carcus Dresden

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP

location_facility: GH est - Hôpital Cardiovasculaire et Pneumologie Louis Pradel

location_facility: University of North Carolina at Chapel Hill

location_facility: Klinikum Würzburg Mitte gGmbH Standort Missioklinik


title: A 12-month Prospective, Randomized, Interventional, Global, Multi-center, Active-controlled Study Comparing Sustained Benefit of Two Treatment Paradigms (AMG334 qm vs. Oral Prophylactics) in Adult Episodic Migraine Patients

summary: The purpose of this study is to compare the sustained long-term benefit between two treatment paradigms of migraine prophylactic agents (erenumab versus a control arm of oral prophylactics) in episodic migraine patients who have previously failed 1 to 2 prophylactic migraine treatments.

ipd_sharing_description:
Data sharing for this study is the responsibility of Novartis. 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: Amgen

sponsor_collaborators: Amgen Novartis

location_country:
Finland
Germany
Ireland
Italy
Poland
Portugal
Slovakia
Israel
Argentina
United Kingdom
Netherlands
Austria
Belgium
United States
Spain
Greece
Czechia
France

location_facility: General Hospital of Patra O AGIOS ANDREAS Neurology Clinic

location_facility: University Hospital of North Midlands NHS Trust

location_facility: Hull and amp East Yorkshire Hospitals NHS Trust

location_facility: ASST degli Spedali Civili di Brescia Univ degli Studi

location_facility: Neurologische Gemeinschaftspraxis Klemt & Bauersachs

location_facility: A O Perugia Osp S Maria Misericordia Loc S Andrea d Fratte

location_facility: Euromedica General Clinic of Thessaloniki Neurology Dept

location_facility: Azienda Ospedaliera Sant'Andrea - Università La Sapienza

location_facility: Texas Institute for Neurological Disorders

location_facility: Hopital Lariboisiere Centre d Urgence des Cephalees

location_facility: New England Regional Headache Center, Inc

location_facility: Aeginition Hospital of Athens, University of Athens

location_facility: Hopital Charles Nicolle Departement de Neurologie

location_facility: Neurologische Gemeinschaftpraxis im Bienenkorbhaus

location_facility: Tel Aviv Sourasky Medical Center Ichilov

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: 401 Army General Hospital of Athens Main Centre

location_facility: Canisius Wilhelmina Hospital Dept of Neurology C-70

location_facility: Neurologicka a algeziologicka ambulancia SANERA s r o

location_facility: Hospital Clinico Universitario de Santiago

location_facility: IDIM Instituto de Investigaciones Metabolicas

location_facility: New England Institute for Neurology and Headache

location_facility: Ordensklinikum Linz Barmherzigen Schwestern

location_facility: Navy Hospital of Athens "NNA" Main Centre

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Centro Hospitalar do Porto Hospital Geral de Santo Antonio Serviço de Neurologia

location_facility: Policl.Universit.Campus Bio-Medico Università Campus Bio-Med U.O.C.Area di Oncologia Medica

location_facility: Jessa Ziekenhuis- Campus Virga Jesse Dienst Gastro-entrologie


summary: This was a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria (CSU) patients inadequately controlled by H1-antihistamines

title: A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase 2b Dose-finding Study to Investigate the Efficacy, Safety and Tolerability of LOU064 in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines

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

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

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

ipd_sharing: Undecided


title: A Phase 3 Trial of Bardoxolone Methyl in Patients With Autosomal Dominant Polycystic Kidney Disease

acronym: FALCON

summary: This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD. Approximately 850 patients will be enrolled.

location_country:
Germany
Italy
United Kingdom
Australia
Japan
Belgium
United States
Spain
Czechia
France

location_facility: KidneyCare and Tranplant Services of New England

location_facility: Renal and Transplant Associates of New England, PC

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University Hospitals Leuven, Dept. of Nephrology, Dialysis and Renal Transplantation

location_facility: Tokyo Women's Medical University Hospital

location_facility: University of Cincinnati College of Medicine

location_facility: Japan Community Healthcare Organization Sendai Hospital

location_facility: Nephrology Dept., General Teaching Hospital

location_facility: Niigata University Medical & Dental Hospital

location_facility: North Carolina Nephrology, P.A. 2nd Floor

location_facility: Manchester University NHS Foundation Trust

location_facility: Brookview Hills Research Associates, LLC

location_facility: Renal Division, ASST Santi Paolo e Carlo

location_facility: Nephrology Associates of Northern Virginia, Inc.

location_facility: Mountain Kidney & Hypertension Associates

location_facility: Hopital Necker, Universite Paris Descartes

location_facility: University of Maryland School of Medicine

location_facility: Western Nephrology and Mineral Bone Disease, PC

location_facility: Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital

location_facility: University of Colorado Anschutz Medical Center

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Division of Kidney Diseases and Hypertension

location_facility: Paragon Health PC d/b/a Nephrology Center PC

location_facility: Kansas Nephrology Research Institute, LLC


title: A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients With Short Bowel Syndrome (SBS)

acronym: EASE SBS 2

summary:
The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS).

Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

lead_sponsor: Zealand Pharma

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

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Vanderbilt University Medical Center, Nashville

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

location_facility: University of Chicago Children's Hospital

location_facility: Azienda Ospedaliero Universitaria Federico II

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

location_facility: Universitätsklinikum Tübingen - Innere Medizin I

location_facility: Division of Gastroenterology and Hepatology

location_facility: Universitätsklinikum Frankfurt - Med. Klinik I

location_facility: University Health Network - Toronto General Hospital


acronym: TWINSS

summary: This study will evaluate safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome.

title: A 48-week, 6-arm, Randomized, Double-blind, Placebo-controlled Multicenter Trial to Assess the Safety and Efficacy of Multiple CFZ533 Doses Administered Subcutaneously in Two Distinct Populations of Patients With Sjogren's Syndrome (TWINSS)

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:
Germany
Argentina
Australia
Brazil
Japan
Turkey
Chile
Canada
France
Colombia
Portugal
Hungary
United States
Romania
Italy
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Greece
Russian Federation
Israel


title: A Multicentre Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety, Tolerability, Efficacy, Dose-response, Pharmacokinetics and Pharmacodynamics of Repeat Dosing of an Anti-LAG3 Cell Depleting Monoclonal Antibody (GSK2831781) in Patients With Active Ulcerative Colitis

summary: This is a Phase 2, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the safety, tolerability, efficacy and dose-response of GSK2831781 in participants with moderate to severe active ulcerative colitis. The study consists of a 5-week screening window, 10-week Induction Phase, 30-week double-blind Extended Treatment Phase (ETP) with 42-week Follow-Up Phase. Non-Responders identified following the Week 10 assessment will be allocated to open label treatment, consisting of Induction (Weeks 12 to 22), an Open label ETP (Weeks 22 to 42) and a follow-Up to Week 54.

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

lead_sponsor: GlaxoSmithKline

location_country:
Poland
India
Slovakia
United Kingdom
Japan
Netherlands
United States
South Africa
Czechia
Ukraine
Bulgaria
Estonia
Serbia
Russian Federation
France


intervention_type: Biological

acronym: rVWF Pediatric and Adult Study

lead_sponsor: Baxalta now part of Shire

summary:
The main aim of the study is to check effectiveness of rVWF (vonicog alfa) prophylaxis based on the annualized bleeding rate (ABR) of spontaneous (not related to trauma) bleeding episodes in pediatric and adult participants during the first 12 months on study treatment.

The participants will be treated with rVWF for a maximum of 3 years. Their von Willebrand Disease will be treated according to Investigational product (IP) dosing directions.

sponsor_collaborators: Takeda Development Center Americas, Inc.

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: University of Florida College of Medicine

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Groupement Hospitalier Est- Hôpital Louis Pradel

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Azienda Ospedaliera Pediatrica Santobono Pausillipon

location_facility: Medical University of South Carolina (MUSC)

location_facility: Hospital General Universitario de Alicante

location_facility: Arkansas Children's Hospital Research Institute

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: SAIH "Kemerovo Regional Clinical Hospital"

location_facility: Azienda Ospedaliera Universitaria Careggi

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

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

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

title: A Phase 3b, Prospective, Open-Label, Uncontrolled, Multicenter Study on Long-Term Safety and Efficacy of rVWF in Pediatric and Adult Subjects With Severe Von Willebrand Disease (VWD)

primary_purpose: Prevention

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.

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


title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

summary: A Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with MIBC and in participants with locally advanced or metastatic Urothelial Carcinoma (UC) who have progressed during or following a platinum-containing regimen. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population (e.g., with regard to prior anti-cancer treatment or biomarker status). Participants in the mUC Cohort who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen for Stage 2.

lead_sponsor: Hoffmann-La Roche

collaborators: Gilead Sciences, Inc., GlaxoSmithKline plc, Seattle Genetics and Astellas

location_country:
United Kingdom
United States
Spain
Korea, Republic of
Greece
Taiwan
France

location_facility: University Hospitals Cleveland Medical Center

location_facility: Churchill Hospital; Pharmacy Clinical Trials Office, Pharmacy Department

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Attiko Hospital University of Athens; 2Nd Dept. of Propaedeutic Medicine

location_facility: ICO I Hospitalet Hospital Duran i Reynals Instituto Catalan de Oncologia de Hospitalet ICO

location_facility: Hospital Clinic i Provincial; Servicio de Neurologia

location_facility: National Taiwan University Hospital, Yun-Lin Branch

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Intermedios y Urgencias Pediatricas

location_facility: Hospital General Universitario Gregorio Mara

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Severance Hospital; Yonsei Cancer Center; Yonsei University College of Medicine

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

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

location_facility: Hospital Clinico Universitario de Valencia

location_facility: University Hospital of Patras Medical Oncology

location_facility: Athens Medical Center; Dept. of Oncology

location_facility: University of Kentucky Chandler Medical Center


summary: This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single agent in maintenance for treating participants with acute myeloid leukemia (AML).

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: University of Kansas Clinical Research Center; Clinical Trials Office

location_facility: University of Iowa Hospitals and Clinics; Investigational Drug Services

location_facility: Hospital Universitario Virgen del Rocío; Servicio de Neuropediatra

location_facility: ASST Papa Giovanni XXIII; Dipartimento Interaziendale di Farmacia Clinica

location_facility: Sarah Cannon Research Institute at HealthONE

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST); Onco-Ematologia

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

title: A Phase Ib/II Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the 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 Sharing of Clinical Study 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:
Italy
Australia
United States
Spain
France


title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)

acronym: SLE-BRAVE-X

summary: The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Incyte Corporation

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Croatia
Chile
Czechia
Serbia
France
Colombia
Hungary
Switzerland
United States
India
Romania
Belgium
China
Philippines
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel

location_facility: Immanuel Krankenhaus Rheuma Klinik Berlin Buch

location_facility: Tianjin Medical University General Hospital

location_facility: Klinika Reumatologii, Chorob Wewnetrznych i Geriatrii PUM

location_facility: The Feinstein Institute for Medical Research

location_facility: CINVEC- Estudos Clínicos Quinta Región Limitada

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: First Affiliated Hospital of the Harbin Medical University

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.

location_facility: Klinikum der Universität München Großhadern

location_facility: Angeles University Foundation and Medical Center

location_facility: The First Affiliated Hospital of Zhengzhou Universtiy

location_facility: Centro Peninsular de Investigacion S.C.P

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: The Rheumatology Research Unit Sunshine Coast

location_facility: Napoca Emergency Clinical County Hospital

location_facility: Regional General University Hospital of Larissa

location_facility: Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

location_facility: Clinica para el Diagnostico y Tratamiento de la Enfermedades

location_facility: Shanghai Huashan Hospital Affil to Fu Dan University

location_facility: Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum

location_facility: Russian Medical Military Academy n.a. S.M. Kirov

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: First affiliated Hospital of Sun Yat-Sen University

location_facility: Gen. Hosp. of Thessaloniki "Hippokration"

location_facility: City Clinical Hospital 1 named after N.I. Pirogov

location_facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

location_facility: Kasturba Medical College Hospital, Mangalore

location_facility: Arthritis and Osteoporosis Associates of New Mexico

location_facility: Sociedad Medica Del Aparato Locomotor SA

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: The First Affliated Hospital of Suzhou University

location_facility: Synexus Affiliate - Sujata Birla Hospital & Medical Research Center

location_facility: Research Institute of Clinical Immunology

location_facility: Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)

location_facility: Integral Rheumatology & Immunology Specialists

location_facility: Inland Rheumatology & Osteoporosis Medical Group

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: Departmental Hospital at Smolensk Station "rzhd" JSC

location_facility: HPTU-El Hospital con alma Pablo Tobon Uribe

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S. C.

location_facility: Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences

location_facility: ChanRe Rheumatology And Immunology Center And Research

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.

location_facility: Cincinnati Rheumatic Disease Study Group

location_facility: Universitätsmedizin Johannes Gutenberg Universität Mainz

location_facility: Orenburg State Medical Academy of Roszdrav

location_facility: Arthritis & Rheumatology Center of Oklahoma PLLC

location_facility: Azienda Ospedaliera Santa Maria Della Misericordia

location_facility: IR Medical Center S.A. Instituto de Reumatologia

location_facility: SER - Serviços Especializados em Reumatologia da Bahia S/S - ME

location_facility: Vrije Universiteit Medisch Centrum Amsterdam

location_facility: Centre hospitalier universitaire Pellegrin

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Chorob Tkanki Lacznej

location_facility: Seoul National University Bundang Hospital

location_facility: Centro de Estudos em Terapias Inovadoras-CETI

location_facility: Beijing Peking Union Medical College Hospital

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika

location_facility: Centro de Investigación y Tratamiento Reumatológico S.C

location_facility: Arizona Arthritis & Rheumatology Associates, P. C.

location_facility: Morales Vargas Centro de Investigacion, S.C.

location_facility: People's Hospital of Xinjiang Uygur Autonomous Region

location_facility: Békés Megyei Központi Kórház Pándy Kálmán Tagkórház

location_facility: Twoja Przychodnia Centrum Medyczne Nowa Sol

location_facility: Centro de Alta Especialidad Reumatologia Inv del Potosi SC

location_facility: University General Hospital of Heraklion

location_facility: Arizona Arthritis & Rheumatology Research

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

location_facility: Institute for Treatment and Rehabilitation Niska Banja

location_facility: Centro Integral en Reumatologia SA de CV

location_facility: Clinical Research of West Florida, Inc. (Clearwater)

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

location_facility: Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk

location_facility: Precision Comprehensive Clinical Research Solutions

location_facility: Russian National Research Medical University n.a. N.I.Pirogov

location_facility: Sushruta Multispecialty Hospital & Research Center Pvt Ltd

location_facility: Box Arthritis & Rheumatology of the Carolinas, PLLC

location_facility: Articularis Healthcare d/b/a/ Low Country Rheumatology, PA

location_facility: V.A. Nasonova Research Institute of Rheumatology

location_facility: Suite 509 Umhlanga Netcare Medical Centre

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: University of Occupational and Enviromental Health

location_facility: Oncovida- Centro de Onco-Hematologia de Mato Grosso

location_facility: China Medical University (CMU) - First Affiliated Hospital

location_facility: Craiova Emergency Clinical County Hospital

location_facility: Aprillus Asistencia e Investigacion de Arcis Salud SRL


title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients With Moderate Alzheimer's Disease

summary: This Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the clinical efficacy, safety, pharmacokinetics, and pharmacodynamics of semorinemab in patients with moderate AD. The study consists of a screening period, a double-blind treatment period, an optional open-label extension (OLE) period, and a safety follow-up period. There may be up to two study cohorts.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). 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: Genentech, Inc.

location_country:
United States
Spain
Poland
France

location_facility: Butler Hospital; Movement Disorders Program

location_facility: Empire Neurology PC; MS Center of Northeastern NY

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Stanford University; Stanford Clinical Cancer Ctr

location_facility: New Orleans Center for Clinical Research

location_facility: Southern Illinois University, School of Medicine

location_facility: Alzheimer?s Research and Treatment Center

location_facility: Collaborative Neuroscience Network, Inc.

location_facility: Rush University Medical Center - Chicago

location_facility: Advanced Memory Research Institute of NJ

location_facility: Synexus Clinical Research US, Inc. - Orlando

location_facility: Neuropsychiatric Research; Center of Southwest Florida

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Brigham and Womens Hospital; Center for Alzheimer Research & Treatment

location_facility: NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

location_facility: KI Health Partners, LLC; New England Institute for Clinical Research


title: An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion

acronym: RAVEN

summary: The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO).

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Australia
Japan
Thailand
Turkey
Czechia
Canada
France
Hungary
United States
China
Malaysia
Puerto Rico
Italy
United Kingdom
Netherlands
Spain
Greece
Russian Federation
Israel


acronym: AEGEAN

lead_sponsor: AstraZeneca

summary: This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.

title: A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)

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.

location_country:
Germany
Poland
Argentina
Japan
Brazil
Costa Rica
Thailand
Vietnam
Chile
Canada
France
Hungary
United States
India
Romania
Belgium
China
Peru
Philippines
Italy
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation