title: A Phase III, Randomized, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 HCV Infection

summary: The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

ReferenceCitation: Sarrazin C, Castelli F, Andreone P, Buti M, Colombo M, Pol S, Calinas F, Puoti M, Olveira A, Shiffman M, Stern JO, Kukolj G, Roehrle M, Aslanyan S, Deng Q, Vinisko R, Mensa FJ, Nelson DR. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naïve patients with chronic hepatitis C virus genotype-1b infection. Clin Exp Gastroenterol. 2016 Nov 24;9:351-363. eCollection 2016.

lead_sponsor: Boehringer Ingelheim

location_country:
Portugal
Spain
Ireland
Austria
Italy
Netherlands
Canada
Russian Federation
United Kingdom
Hungary
United States
France
Romania
Germany

location_facility: 1241.20.35105 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49010 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00012 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01007 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00010 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.70001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.31004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.70005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00015 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00031 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35103 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00013 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39007 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35101 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33007 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35302 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44007 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34007 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35102 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01010 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49011 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.36002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01008 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.31005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.40003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00018 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00022 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00008 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.31003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.36001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00020 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49014 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00016 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49009 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00017 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49013 Boehringer Ingelheim Investigational Site

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location_facility: 1241.20.00019 Boehringer Ingelheim Investigational Site

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location_facility: 1241.20.39008 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33008 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.43003 Boehringer Ingelheim Investigational Site

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location_facility: 1241.20.40001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01002 Boehringer Ingelheim Investigational Site

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location_facility: 1241.20.34006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34004 Boehringer Ingelheim Investigational Site

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location_facility: 1241.20.00002 Boehringer Ingelheim Investigational Site

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location_facility: 1241.20.34002 Boehringer Ingelheim Investigational Site

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location_facility: 1241.20.33001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34001 Boehringer Ingelheim Investigational Site

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location_facility: 1241.20.01005 Boehringer Ingelheim Investigational Site

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location_facility: 1241.20.49007 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00014 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00003 Boehringer Ingelheim Investigational Site

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location_facility: 1241.20.35303 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.70004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34008 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49008 Boehringer Ingelheim Investigational Site


type: EudraCT Number

title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Crohn's Disease

summary: The primary objective of this study is to evaluate the efficacy of abrilumab as measured by the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission (CDAI < 150) after treatment for 8 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: background

ReferenceCitation: Dummer R, Hoeller C, Gruter IP, Michielin O. Combining talimogene laherparepvec with immunotherapies in melanoma and other solid tumors. Cancer Immunol Immunother. 2017 Jun;66(6):683-695. doi: 10.1007/s00262-017-1967-1. Epub 2017 Feb 25. Review.

lead_sponsor: Amgen

location_country:
Denmark
United Kingdom
Austria
Netherlands
Canada
Switzerland
Hungary
United States
France
Belgium
Germany
Czechia

location_facility:
Hospital
Research Site

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Prospective, Randomized, Open-label, Parallel-group, Active-controlled, Multicenter Study Exploring the Efficacy and Safety of Once-daily Oral Rivaroxaban (BAY59-7939) Compared With That of Dose-adjusted Oral Vitamin K Antagonists (VKA) for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion

acronym: X-VERT

summary: A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm). The study will compare patients assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA). The study will measure common medical outcomes for this type of patient such as bleeding and stroke.

primary_purpose: Prevention

ReferenceCitation: Cappato R, Ezekowitz MD, Klein AL, Camm AJ, Ma CS, Le Heuzey JY, Talajic M, Scanavacca M, Vardas PE, Kirchhof P, Hemmrich M, Lanius V, Meng IL, Wildgoose P, van Eickels M, Hohnloser SH; X-VeRT Investigators. Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation. Eur Heart J. 2014 Dec 14;35(47):3346-55. doi: 10.1093/eurheartj/ehu367. Epub 2014 Sep 2.

ReferenceCitation: Hai Z, Guangrui S. Cardiac paraganglioma. Eur Heart J. 2018 Jun 14;39(23):2219. doi: 10.1093/eurheartj/ehu241.

lead_sponsor: Bayer

location_country:
Denmark
Brazil
Portugal
Spain
Greece
Italy
Netherlands
United Kingdom
Canada
Finland
United States
France
China
Singapore
Belgium
South Africa
Germany


type: Other Identifier

title: Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer

summary: The purpose of this study is to evaluate the prevalence of 4 or more DNA-repair gene defects in a population of men with metastatic Prostate Cancer (PC) and to use the reported DNA-repair gene defects to assess biomarker eligibility for niraparib interventional studies.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Janssen Research & Development, LLC

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Poland
Russian Federation
Australia
Argentina
Israel
Turkey
Sweden
Malaysia
Brazil
Canada
Germany
Bulgaria
Denmark
Taiwan
Belarus
Thailand
Korea, Republic of
France
Netherlands

location_facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

location_facility: Centre hospitalier universitaire de Québec (CHUQ), L'Hotel-Dieu de Quebéc

location_facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Sakarya University Training and Research Hospital

location_facility: Centro de Tratamento de câncer Medradius

location_facility: Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine

location_facility: Hôpitaux Universitaire de Strasbourg -CHU

location_facility: Miami Cancer Institute at Baptist Health / Baptist Health Medical Group

location_facility: Irmandade Santa Casa de Misericordia de Sao Paulo

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba

location_facility: Institut de Cancérologie de l'Ouest (ICO)

location_facility: Communal Nonprofit Enterprise 'Regional Clinical Oncology Center of Kirovohrad Regional Council'

location_facility: Urologische Gemeinschaftspraxis Böhm/Linne - Germany

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

location_facility: Multifunctional clinical medical center 'Medical city'

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Przychodnia Lekarska KOMED Roman Karaszewski

location_facility: Russian Scientific Center of Radiology and Surgical Technologies

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Gomel Regional Clinical Oncology Dispensary

location_facility: Seoul National University Bundang Hospital

location_facility: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd

location_facility: Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council

location_facility: Centers for Advanced Urology, LLC; d/b/a MidLantic Urology

location_facility: Specjalistyczna przychodnia lekarska POLIMED

location_facility: Hospital Privado - Centro Medico de Cordoba

location_facility: Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi

location_facility: Urologie im Schlosscarree Schreier/Eichler/Junius - Germany

location_facility: State Institution National Cancer Institute

location_facility: Eastern Connecticut Hematology & Oncology Assoc.

location_facility: Communal Institution of Ternopil Regional Council 'Ternopil Regional Oncology Center'

location_facility: Texas Oncology-Midland Allison Cancer Center

location_facility: Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

location_facility: ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'

location_facility: British Columbia Cancer Agency - Vancouver Island Centre

location_facility: Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Frederick Health Hospital - James M Stockman Cancer Institute

location_facility: Klinikum Region Hannover Klinikum Siloah

location_facility: Azienda ULSS5 Polesana di Rovigo - Ospedale Santa Maria della Misericordia

location_facility: Azienda ULSS 3 Serenissima, presidio di Mirano

location_facility: Centre de radiothérapie et d'Oncologie médicale de l'Essonne

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

location_facility: Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council

location_facility: CINME - Centro de Investigaciones Metabolicas

location_facility: Beth Israel Deaconess Hospital Plymouth, Jordan Club Cancer Center

location_facility: Urologica Praktyka Lekarska Adam Marcheluk

location_facility: Instituto de Ensino E Pesquisa Sao Lucas

location_facility: Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia

location_facility: PERSONAL - Oncologia de Precisão e Personalizada

location_facility: District Oncology Dispensary with In-Patient Stationary - Plovdiv

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital

location_facility: Fundação Antônio Prudente - A.C. Camargo Cancer Center

location_facility: British Columbia Cancer Agency (BCCA) - Vancouver Centre

location_facility: Universidade Do Estado Do Rio De Janeiro

location_facility: Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.

location_facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

location_facility: Urological Associates of Southern Arizona, P.C.

location_facility: State Institution N.N. Alexandrov Republican Scientific and

location_facility: Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council

location_facility: Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal

location_facility: Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

location_facility: CUROS - Uberörtliche urologische Gemeinschaftspraxis

location_facility: Centre Hopitalier Inter-Communal De Cornouaille

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

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

location_facility: Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre)

location_facility: Bobruisk Interregional Oncological Dispensary

location_facility: Instituto Joinvilense De Hematologia e Oncologia

location_facility: University Health Network (UHN) Princess Margaret Cancer Centre

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: MemorialCare Research Miller Children's and Women's Hospital Long Beach

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Fort Wayne Medical Oncology and Hematology, Inc.

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka

location_facility: Consultants in Medical Oncology and Hematology, P.C. - Abington

location_facility: Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: Azienda Ulss 6 Euganea- Ospedale Di Camposampiero

location_facility: Adult Pediatric Urology & Urogynecology, P.C

location_facility: Municipal non-profit enterprise 'Regional Center of Oncology'

location_facility: Kyungpook National University Chilgok Hospital

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

location_facility: PP.OO. di Piombino e Portoferraio Azienda USL Toscana nord ovest

location_facility: Suporte Nutricional e Quimioterapia Ltda - Pronutrir

location_facility: Minsk city Clinical Oncological Dispensary

location_facility: Private Medical Institution Euromedservice

location_facility: Texas Oncology Deke Slayton Cancer Center

location_facility: Centre Hospitalier Regional Universitaire Besancon

location_facility: University of Washington School of Medicine

location_facility: Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás

location_facility: Southern Alberta Institute of Urology / Prostate Cancer Centre

location_facility: Virginia Commonwealth University - Massey Cancer Center

location_facility: Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval

location_facility: State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center

location_facility: T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Instituto do Cancer Arnaldo Vieira de Carvalho

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: uro Eimsbüttel - Gemeinschaftspraxis Bath/Weinzierl

intervention_type: Other

status_simplified: Ongoing


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia

acronym: Tugela

summary: The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)

ReferenceCitation: Zelenetz AD, Robak T, et al. Idelalisib Plus Bendamustine and Rituximab (BR) Is Superior to BR Alone in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results of a Phase 3 Randomized Double-Blind Placebo-Controlled Study. American Society ofHematology (ASH) 57th Annual Meeting & Exposition; 5-8 December 2015; Orlando, FL.

ReferenceCitation: Barrientos JC, Brown JR, et al. Results of a Randomized Double-Blind Placebo-Controlled Phase 3 study Evaluating Idelalisib in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL and Adverse Prognostic Features. American Society of Clinical Oncology (ASCO) 2016 Annual Meeting; 3-7 June 2016; Chicago, IL.

ReferenceCitation: Hillmen, P, Ferra C, et al. Idelalisib in Combination with Bendamustine and Rituximab Improves Overall Survival in Patients with Relapsed/Refractory CLL: Interim Results of a Phase 3 Randomized Double-Blind Placebo-Controlled Study. European Hematology Association (EHA) 21st Annual Meeting; 9-12 June 2016; Copenhagen, Denmark.

ReferenceCitation: Zelenetz AD, Brown JR et al. Updated Analysis of Overall Survival in Randomized Phase III Study of Idelalisib in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL. American Society of Hematology (ASH) 58th Annual Meeting & Exposition; 3-6 December 2016; San Diego, CA

ReferenceCitation: Zelenetz AD, Barrientos JC, Brown JR, Coiffier B, Delgado J, Egyed M, Ghia P, Illés Á, Jurczak W, Marlton P, Montillo M, Morschhauser F, Pristupa AS, Robak T, Sharman JP, Simpson D, Smolej L, Tausch E, Adewoye AH, Dreiling LK, Kim Y, Stilgenbauer S, Hillmen P. Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2017 Mar;18(3):297-311. doi: 10.1016/S1470-2045(16)30671-4. Epub 2017 Jan 28.

ReferenceType: derived

ReferenceCitation: Montillo M, Illés Á, Robak T, Pristupa AS, Wach M, Egyed M, Delgado J, Jurczak W, Morschhauser F, Schuh A, Eradat H, Shreay S, Barrientos JC, Zelenetz AD. Idelalisib addition has neutral to beneficial effects on quality of life in bendamustine/rituximab-treated patients: results of a phase 3, randomized, controlled trial. Health Qual Life Outcomes. 2019 Nov 15;17(1):173. doi: 10.1186/s12955-019-1232-8.

ipd_sharing: Yes

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

lead_sponsor: Gilead Sciences

location_country:
Croatia
Poland
Portugal
Romania
Spain
Greece
Ireland
Australia
Italy
Canada
Russian Federation
United Kingdom
Hungary
United States
France
Turkey
Belgium
Czechia

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: Winship Cancer Institute at Emory University

location_facility: Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko

location_facility: Research Institute of Hematology and Blood Transfusion

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

location_facility: Centralny Szpital Kliniczny MSW w Warszawie

location_facility: Ospedale Oncologico Regionale A. Businco

location_facility: Azienda Ospedaliera Universitaria San Giovanni Battista-Molinette

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum

location_facility: Emergency County Clinical Hospital Brasov

location_facility: Ondokuz Mayis University Faculty of Medicine

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

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

location_facility: "Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)

location_facility: Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary #1

location_facility: Gazi University Medical Faculty Gazi Hospital

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes

location_facility: Russian Oncology Research Center (N.N. Blokhin)

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Hospital Universitario Germans Trias i Pujol


type: Registry Identifier

title: A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment With One Next-generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010)

summary:
The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5'-diphosphoribose poly(ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy.

The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to:

Overall Survival (OS) and
Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR)

status: Active, not recruiting

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Taiwan
Brazil
Spain
Ireland
Austria
Australia
Italy
Argentina
Canada
Netherlands
New Zealand
Russian Federation
Korea, Republic of
United States
Chile
France
Israel
United Kingdom
Japan
Germany

location_facility: University Hospitals of Cleveland Seidman Cancer Center ( Site 0036)

location_facility: Barbara Ann Karmanos Cancer Institute ( Site 0077)

location_facility: Georgia Cancer Center at Augusta University ( Site 0026)

location_facility: Pontificia Universidad Catolica de Chile ( Site 1047)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)

location_facility: Saitama Medical University International Medical Center ( Site 0708)

location_facility: Universitaetsklinikum Erlangen ( Site 0303)

location_facility: Nara Medical University Hospital ( Site 0715)

location_facility: CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)

location_facility: Institut De Cancerologie De L Ouest ( Site 0448)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)

location_facility: University of New Mexico Cancer Center ( Site 0048)

location_facility: Presidio Ospedaliero Santa Chiara ( Site 0451)

location_facility: Vrije Universiteit Medisch Centrum ( Site 0479)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 0452)

location_facility: Royal Brisbane and Women s Hospital ( Site 0155)

location_facility: Centre D Oncologie de Gentilly ( Site 0432)

location_facility: Carolina Urologic Research Center ( Site 0070)

location_facility: Hamamatsu University Hospital ( Site 0720)

location_facility: Haaglanden MC - locatie Antoniushove ( Site 0471)

location_facility: Fujita Health University Hospital ( Site 0724)

location_facility: Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579)

location_facility: Gabrail Cancer Center-Research ( Site 0097)

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0462)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 0330)

location_facility: Kobe City Medical Center General Hospital ( Site 0726)

location_facility: Fondazione Policlinico Universitario A. Gemelli ( Site 0463)

location_facility: Institut Regional du Cancer de Montpellier - ICM ( Site 0443)

location_facility: Kanazawa University Hospital ( Site 0701)

location_facility: Centro de Diagnostico Urologico ( Site 1008)

location_facility: St. Joseph Heritage Healthcare ( Site 0069)

location_facility: Chonnam National University Hwasun Hospital ( Site 0174)

location_facility: Taichung Veterans General Hospital ( Site 0133)

location_facility: Radboud University Medical Center ( Site 0470)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0418)

location_facility: The Urology Group- Cincinnati ( Site 0094)

location_facility: Chesapeake Urology Research Associates ( Site 0076)

location_facility: Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 1022)

location_facility: Azienda Ospedaliera Cannizzaro ( Site 0458)

location_facility: Hospital General Universitari Vall d Hebron ( Site 0334)

location_facility: Antoni van Leeuwenhoek Ziekenhuis ( Site 0480)

location_facility: Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)

location_facility: Policlinico S.Orsola-Malpighi ( Site 0453)

location_facility: Centre Hospitalier Regional du Orleans ( Site 0430)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0103)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 0092)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)

location_facility: Nova Scotia Health Authority QEII-HSC ( Site 0114)

location_facility: University of Miyazaki Hospital ( Site 0721)

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 0559)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)

location_facility: Universitaetsklinik fuer Urologie ( Site 0307)

location_facility: Kitasato University Hospital ( Site 0705)

location_facility: University Hospitals Bristol NHS Foundation Trust ( Site 0530)

location_facility: University of North Midlands NHS Foundation Trust ( Site 0527)

location_facility: Peter MacCallum Cancer Centre ( Site 0152)

location_facility: Bradford Hill Centro de Investigaciones Clinicas ( Site 1044)

location_facility: Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)

location_facility: Southern Medical Day Care Centre ( Site 0160)

location_facility: Medizinische Universitat Graz ( Site 0374)

location_facility: Instituto Medico Alexander Fleming ( Site 1010)

location_facility: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0301)

location_facility: Yamaguchi University Hospital ( Site 0717)

location_facility: Omsk Clinical Oncology Dispensary ( Site 0568)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 0337)

location_facility: Hospital Britanico de Buenos Aires ( Site 1006)

location_facility: CHU Amiens Picardie Site Sud Amiens ( Site 0438)

location_facility: Cambridge University Hospitals NHS Trust ( Site 0540)

location_facility: Azienda Ospedaliera Santa Maria Terni ( Site 0456)

location_facility: Clinical Research Center of specialized types medical care-Oncology ( Site 0570)

location_facility: Medizinische Universitaet Wien ( Site 0375)

location_facility: SBHI Leningrad Regional Oncology Dispensary ( Site 0588)

location_facility: Tallaght University Hospital ( Site 0730)

location_facility: Associated Medical Professionals of NY ( Site 0060)

location_facility: Taipei Veterans General Hospital ( Site 0135)

location_facility: Osaka International Cancer Institute ( Site 0722)

location_facility: Nippon Medical School Hospital ( Site 0709)

location_facility: UMass Memorial Medical Center ( Site 0053)

location_facility: Dokkyo Medical University Saitama Medical Center ( Site 0707)

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0005)

location_facility: Dana Farber Cancer Institute ( Site 0033)

location_facility: National Cheng Kung University Hospital ( Site 0134)

location_facility: Beth Israel Deaconess Medical Ctr. ( Site 0093)

location_facility: Toho University Sakura Medical Center ( Site 0703)

location_facility: Port Macquarie Base Hospital ( Site 0153)

location_facility: St. Vincent Frontier Cancer Center ( Site 0016)

location_facility: Universitaetsklinikum in Mannheim ( Site 0314)

location_facility: National Cancer Center Hospital East ( Site 0702)

location_facility: Froedtert and Medical College of Wisconsin ( Site 0045)

location_facility: Hospital San Pedro de Alcantara ( Site 0326)

location_facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)

location_facility: Fundacion Arturo Lopez Perez ( Site 1049)

location_facility: John Flynn Hospital & Medical Centre ( Site 0164)

location_facility: Severance Hospital Yonsei University Health System ( Site 0173)

location_facility: UCLA Hematology/Oncology - Santa Monica ( Site 0081)

location_facility: Medical Oncology Ospedale San Donato ( Site 0461)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 0716)

location_facility: China Medical University Hospital ( Site 0132)

location_facility: Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 0441)

location_facility: Yokohama City University Medical Center ( Site 0706)

location_facility: Nagasaki University Hospital ( Site 0719)

location_facility: William Osler Health System (Brampton Civic Hospital) ( Site 0121)

location_facility: Universitaetsklinikum Duesseldorf ( Site 0306)

location_facility: Franciscus Gasthuis en Vlietland ( Site 0489)

location_facility: Nebraska Cancer Specialists ( Site 0034)

location_facility: Centro Investigación del Cáncer James Lind ( Site 1041)

location_facility: IBCC - Instituto Brasileiro de Controle do Câncer ( Site 1040)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0546)

location_facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)

location_facility: Princess Margaret Cancer Centre ( Site 0107)

location_facility: Central Clinical Hospital with Polyclinic ( Site 0562)

location_facility: Azienda Ospedaliera San Camillo Forlanini ( Site 0455)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013)

location_facility: Hospital de Caridade de Ijui ( Site 1038)

location_facility: BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0113)

location_facility: National Taiwan University Hospital ( Site 0131)

location_facility: Institut Mutualiste Montsouris ( Site 0446)

location_facility: Seattle Cancer Care Alliance ( Site 0079)

location_facility: Instituto de Investigaciones Metabolicas ( Site 1011)

intervention_type: Biological


title: A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)

summary:
The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA).

There are two primary study hypotheses.

Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS).

Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.

ReferenceCitation: Petrylak DP, Ratta R, Gafanov R, Facchini G, Piulats JM, Kramer G, Flaig TW, Chandana SR, Li B, Burgents J, Fizazi K. KEYNOTE-921: Phase III study of pembrolizumab plus docetaxel for metastatic castration-resistant prostate cancer. Future Oncol. 2021 Sep;17(25):3291-3299. doi: 10.2217/fon-2020-1133. Epub 2021 Jun 8.

location_country:
Spain
Italy
United Kingdom
United States
Japan
Austria
Australia
Russian Federation
Argentina
Israel
Brazil
Canada
China
Germany
Taiwan
Ireland
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Georgia Cancer Center at Augusta University ( Site 0026)

location_facility: Instituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011)

location_facility: Zhejiang Provincial People's Hospital ( Site 1310)

location_facility: Pontificia Universidad Catolica de Chile ( Site 1047)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)

location_facility: Saitama Medical University International Medical Center ( Site 0708)

location_facility: Nara Medical University Hospital ( Site 0715)

location_facility: CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)

location_facility: Institut De Cancerologie De L Ouest ( Site 0448)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)

location_facility: Presidio Ospedaliero Santa Chiara ( Site 0451)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 0337)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 0452)

location_facility: Seoul National University Hospital ( Site 0171)

location_facility: Harbin Medical University Cancer Hospital ( Site 1326)

location_facility: Cambridge University Hospitals NHS Trust ( Site 0540)

location_facility: W. G. Bill Hefner VA Medical Center ( Site 0029)

location_facility: Centre D Oncologie de Gentilly ( Site 0432)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0457)

location_facility: Carolina Urologic Research Center ( Site 0070)

location_facility: Fudan University Shanghai Cancer Center ( Site 1300)

location_facility: Hamamatsu University Hospital ( Site 0720)

location_facility: National Medical Research Radiological Center ( Site 0556)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1068)

location_facility: Cancer & Hematology Centers of Western Michigan ( Site 0013)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 0330)

location_facility: Peking University First Hospital ( Site 1303)

location_facility: Kanazawa University Hospital ( Site 0701)

location_facility: Centro de Diagnostico Urologico ( Site 1008)

location_facility: St. Joseph Heritage Healthcare ( Site 0069)

location_facility: Taichung Veterans General Hospital ( Site 0133)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 1061)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 0336)

location_facility: Radboud University Medical Center ( Site 0470)

location_facility: Oncologos del Occidente S.A. ( Site 1072)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)

location_facility: Zhongshan Hospital Fudan University ( Site 1301)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0418)

location_facility: Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0579)

location_facility: Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)

location_facility: Universitaetsklinikum Goettingen ( Site 0345)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 1022)

location_facility: A.O. Universitaria di Modena ( Site 0454)

location_facility: Methodist Hospital- Merriillville ( Site 0008)

location_facility: University of Southern California Norris Comprehensive Cancer Center ( Site 0061)

location_facility: Azienda Ospedaliera Cannizzaro ( Site 0458)

location_facility: Antoni van Leeuwenhoek Ziekenhuis ( Site 0480)

location_facility: University of Colorado Cancer Center ( Site 0022)

location_facility: Universitaetsklinikum des Saarlandes ( Site 0348)

location_facility: Charite Universitaetsmedizin Berlin ( Site 0301)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 1319)

location_facility: Leningrad Regional Oncology Center ( Site 0588)

location_facility: Hospital Clinico San Carlos ( Site 0324)

location_facility: Centre Hospitalier Regional du Orleans ( Site 0430)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 0092)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)

location_facility: Nova Scotia Health Authority QEII-HSC ( Site 0114)

location_facility: The First Affiliated Hospital of Guangzhou Medical University ( Site 1330)

location_facility: University of Miyazaki Hospital ( Site 0721)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)

location_facility: Sun Yat Sen Memorial Hospital ( Site 1323)

location_facility: University Hospitals Cleveland Medical Center ( Site 0036)

location_facility: Universitaetsklinik fuer Urologie ( Site 0307)

location_facility: Kitasato University Hospital ( Site 0705)

location_facility: University Hospitals Bristol NHS Foundation Trust ( Site 0530)

location_facility: University of North Midlands NHS Foundation Trust ( Site 0527)

location_facility: Bradford Hill Centro de Investigaciones Clinicas ( Site 1044)

location_facility: Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)

location_facility: Medizinische Universitat Graz ( Site 0374)

location_facility: Mount Sinai Hospital Medical Center ( Site 0042)

location_facility: Instituto Medico Alexander Fleming ( Site 1010)

location_facility: Hospital Consorci Sanitari Parc Tauli ( Site 0335)

location_facility: Oregon Health Sciences University ( Site 0031)

location_facility: Yamaguchi University Hospital ( Site 0717)

location_facility: Omsk Clinical Oncology Dispensary ( Site 0568)

location_facility: Hospital Britanico de Buenos Aires ( Site 1006)

location_facility: CHU Amiens Picardie Site Sud Amiens ( Site 0438)

location_facility: The Fifth Medical Center of PLA General Hospital ( Site 1307)

location_facility: Azienda Ospedaliera Santa Maria Terni ( Site 0456)

location_facility: Clinical Research Center of specialized types medical care-Oncology ( Site 0570)

location_facility: Medizinische Universitaet Wien ( Site 0375)

location_facility: Hospital Universitario HM Sanchinarro ( Site 0322)

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 1309)

location_facility: Seoul National University Bundang Hospital ( Site 0175)

location_facility: Tallaght University Hospital ( Site 0730)

location_facility: Washington University School of Medicine ( Site 0057)

location_facility: Sunnybrook Research Institute ( Site 0108)

location_facility: Associated Medical Professionals of NY ( Site 0060)

location_facility: Taipei Veterans General Hospital ( Site 0135)

location_facility: Nanjing Drum Tower Hospital ( Site 1312)

location_facility: Nippon Medical School Hospital ( Site 0709)

location_facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0103)

location_facility: Volga District Medical Center Federal Medical and Biological Agency ( Site 0572)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0328)

location_facility: Dokkyo Medical University Saitama Medical Center ( Site 0707)

location_facility: USC Norris Oncology Hematology Newport Beach ( Site 0093)

location_facility: Centro de Investigaciones Clinicas Vina del Mar ( Site 1042)

location_facility: University of South Alabama, Mitchell Cancer Institute ( Site 0065)

location_facility: SPb SBHI City Clinical Oncological Dispensary ( Site 0571)

location_facility: National Cheng Kung University Hospital ( Site 0134)

location_facility: Toho University Sakura Medical Center ( Site 0703)

location_facility: Port Macquarie Base Hospital ( Site 0153)

location_facility: Inova Schar Cancer Institute ( Site 0006)

location_facility: St. Vincent Frontier Cancer Center ( Site 0016)

location_facility: Universitaetsklinikum in Mannheim ( Site 0314)

location_facility: National Cancer Center Hospital East ( Site 0702)

location_facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)

location_facility: Fundacion Arturo Lopez Perez ( Site 1049)

location_facility: John Flynn Hospital & Medical Centre ( Site 0164)

location_facility: Instituto de Investigaciones Clinicas ( Site 1000)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 0716)

location_facility: China Medical University Hospital ( Site 0132)

location_facility: Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 0441)

location_facility: Yokohama City University Medical Center ( Site 0706)

location_facility: Nagasaki University Hospital ( Site 0719)

location_facility: Russian Scientific Center of Radiology ( Site 0559)

location_facility: Universitaetsklinikum Wuerzburg ( Site 0302)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 1064)

location_facility: SBIH City clinical hospital named after D.D. Pletniov ( Site 0575)

location_facility: University of California San Francisco ( Site 0023)


title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis

acronym: OCTAVE

summary: The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.

ReferenceCitation: Lichtenstein GR, Bressler B, Francisconi C, Vermeire S, Lawendy N, Salese L, Sawyerr G, Shi H, Su C, Judd DT, Jones T, Loftus EV. Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2022 Nov 7. pii: izac084. doi: 10.1093/ibd/izac084. [Epub ahead of print]

ReferenceCitation: Hudesman DP, Torres J, Salese L, Woolcott JC, Mundayat R, Su C, Mosli MH, Allegretti JR. Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program. Patient. 2022 Nov 7. doi: 10.1007/s40271-022-00603-w. [Epub ahead of print]

ReferenceCitation: Winthrop KL, Vermeire S, Long MD, Panés J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2022 Jun 1. pii: izac063. doi: 10.1093/ibd/izac063. [Epub ahead of print]

ReferenceCitation: Vavricka SR, Greuter T, Cohen BL, Reinisch W, Steinwurz F, Fellmann M, Guo X, Lawendy N, Paulissen J, Peyrin-Biroulet L. Corticosteroid-free efficacy and safety outcomes in patients receiving tofacitinib in the OCTAVE Sustain maintenance study. Therap Adv Gastroenterol. 2022 May 10;15:17562848221090834. doi: 10.1177/17562848221090834. eCollection 2022.

ReferenceCitation: Mukherjee A, Tsuchiwata S, Nicholas T, Cook JA, Modesto I, Su C, D'Haens GR, Sandborn WJ. Exposure-Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies. Clin Pharmacol Ther. 2022 Jul;112(1):90-100. doi: 10.1002/cpt.2601. Epub 2022 Apr 27.

ReferenceCitation: Feagan BG, Khanna R, Sandborn WJ, Vermeire S, Reinisch W, Su C, Salese L, Fan H, Paulissen J, Woodworth DA, Niezychowski W, Sands BE. Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1442-1453. doi: 10.1111/apt.16626. Epub 2021 Oct 6.

ReferenceCitation: Farraye FA, Qazi T, Kotze PG, Moore GT, Mundayat R, Lawendy N, Sharma PP, Judd DT. The impact of body mass index on efficacy and safety in the tofacitinib OCTAVE ulcerative colitis clinical programme. Aliment Pharmacol Ther. 2021 Aug;54(4):429-440. doi: 10.1111/apt.16439. Epub 2021 Jun 24.

ReferenceCitation: Rubin DT, Reinisch W, Greuter T, Kotze PG, Pinheiro M, Mundayat R, Maller E, Fellmann M, Lawendy N, Modesto I, Vavricka SR, Lichtenstein GR. Extraintestinal manifestations at baseline, and the effect of tofacitinib, in patients with moderate to severe ulcerative colitis. Therap Adv Gastroenterol. 2021 May 16;14:17562848211005708. doi: 10.1177/17562848211005708. eCollection 2021.

ReferenceCitation: Panés J, Vermeire S, Dubinsky MC, Loftus EV, Lawendy N, Wang W, Salese L, Su C, Modesto I, Guo X, Colombel JF. Efficacy and Safety of Tofacitinib Re-treatment for Ulcerative Colitis After Treatment Interruption: Results from the OCTAVE Clinical Trials. J Crohns Colitis. 2021 Nov 8;15(11):1852-1863. doi: 10.1093/ecco-jcc/jjab065.

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2022 Mar;20(3):591-601.e8. doi: 10.1016/j.cgh.2021.02.043. Epub 2021 Mar 6.

ReferenceCitation: Vong C, Martin SW, Deng C, Xie R, Ito K, Su C, Sandborn WJ, Mukherjee A. Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis. Clin Pharmacol Drug Dev. 2021 Mar;10(3):229-240. doi: 10.1002/cpdd.899. Epub 2021 Jan 29.

ReferenceCitation: Curtis JR, Regueiro M, Yun H, Su C, DiBonaventura M, Lawendy N, Nduaka CI, Koram N, Cappelleri JC, Chan G, Modesto I, Lichtenstein GR. Tofacitinib Treatment Safety in Moderate to Severe Ulcerative Colitis: Comparison of Observational Population Cohort Data From the IBM MarketScan® Administrative Claims Database With Tofacitinib Trial Data. Inflamm Bowel Dis. 2021 Aug 19;27(9):1394-1408. doi: 10.1093/ibd/izaa289.

ReferenceCitation: Colombel JF, Osterman MT, Thorpe AJ, Salese L, Nduaka CI, Zhang H, Lawendy N, Friedman GS, Quirk D, Su C, Reinisch W. Maintenance of Remission With Tofacitinib Therapy in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Jan;20(1):116-125.e5. doi: 10.1016/j.cgh.2020.10.004. Epub 2020 Oct 9.

ReferenceCitation: Sands BE, Colombel JF, Ha C, Farnier M, Armuzzi A, Quirk D, Friedman GS, Kwok K, Salese L, Su C, Taub PR. Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management. Inflamm Bowel Dis. 2021 May 17;27(6):797-808. doi: 10.1093/ibd/izaa227.

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum in: Dig Dis Sci. 2020 Oct 10;:.

ReferenceCitation: Lichtenstein GR, Rogler G, Ciorba MA, Su C, Chan G, Pedersen RD, Lawendy N, Quirk D, Nduaka CI, Thorpe AJ, Panés J. Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2021 May 17;27(6):816-825. doi: 10.1093/ibd/izaa199.

ReferenceCitation: Sandborn WJ, Panés J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.

ReferenceCitation: Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.

ReferenceCitation: Sandborn WJ, Panés J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.

ReferenceCitation: Winthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.

ReferenceCitation: Motoya S, Watanabe M, Kim HJ, Kim YH, Han DS, Yuasa H, Tabira J, Isogawa N, Arai S, Kawaguchi I, Hibi T. Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies. Intest Res. 2018 Apr;16(2):233-245. doi: 10.5217/ir.2018.16.2.233. Epub 2018 Apr 30. Erratum in: Intest Res. 2018 Jul;16(3):499-501.

ReferenceCitation: Panés J, Vermeire S, Lindsay JO, Sands BE, Su C, Friedman G, Zhang H, Yarlas A, Bayliss M, Maher S, Cappelleri JC, Bushmakin AG, Rubin DT. Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies. J Crohns Colitis. 2018 Jan 24;12(2):145-156. doi: 10.1093/ecco-jcc/jjx133. Erratum in: J Crohns Colitis. 2019 Jan 1;13(1):139-140.

ReferenceCitation: Sandborn WJ, Su C, Sands BE, D'Haens GR, Vermeire S, Schreiber S, Danese S, Feagan BG, Reinisch W, Niezychowski W, Friedman G, Lawendy N, Yu D, Woodworth D, Mukherjee A, Zhang H, Healey P, Panés J; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2017 May 4;376(18):1723-1736. doi: 10.1056/NEJMoa1606910.

lead_sponsor: Pfizer

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Romania
South Africa
Poland
Austria
Australia
Russian Federation
Israel
Slovakia
Brazil
Canada
Hungary
Germany
Denmark
Taiwan
Latvia
Estonia
New Zealand
Czech Republic
Korea, Republic of
France
Colombia
Netherlands

location_facility: Limited Liability Company Medical Company "Hepatolog"

location_facility: State Budget Educational Institution of Higher Professional Education

location_facility: North Florida Gastroenterology Research, LLC

location_facility: Municipal Institution "Odesa Regional Clinical Hospital"

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

location_facility: Samara Diagnostic center, X-ray Department

location_facility: Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department

location_facility: Hopital Saint Antoine - Service de Gastroenterologie

location_facility: Carolina Research, Carolina Digestive Diseases

location_facility: State Institution "National L.T. Malaya Therapy Institute of National Academy of

location_facility: Nemocnice Strakonice, a.s., Interni oddeleni

location_facility: Saint Joseph Mercy Hospital - Inpatient Pharmacy

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

location_facility: SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,

location_facility: National Hospital Organization Sendai Medical Center

location_facility: National Hospital Organization Mito Medical Center

location_facility: X-Ray Department, Clinic Linezers (radiology only)

location_facility: Cotton-O'Neal Clinical Research Center Digestive Health

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital

location_facility: UZ Leuven (University Hospital Leuven), Campus Gasthuisberg

location_facility: SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI "Uzhgorod Nat.

location_facility: X-Ray Department of West Tallinn Central Hospital

location_facility: Federal state budget institution "State scientific centre of coloproctology"

location_facility: UCSD Health System - Investigational Drug Pharmacy - Moores Cancer Center

location_facility: Municipal Institution of Healthcare City Clinical Hospital 12,

location_facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine

location_facility: VCU Health System Digestive Health Center

location_facility: X-Ray Unit, East Tallinn Central Hospital

location_facility: Internal Medicine Center of Crimean Republic Institution"Clinical Territorial Medical Community"

location_facility: The Private Practice of Simon Lichtiger, MD

location_facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"

location_facility: State Institution "Institute of Gastroenterology of the National Academy of Medical Sciences of

location_facility: Hospital de Clinicas de Porto Alegre - HCPA

location_facility: State budget institution of healthcare of Yaroslavl region Regional clinical hospital

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Springhill Memorial Hospital (Endoscopy Only)

location_facility: ECG Unit, Innomedica OU and Qualitas AS (ECG Only)

location_facility: Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,

location_facility: Federal State Budgetary Institution "Scientific Research Institute of Physiology and Fundamental

location_facility: Clinical Centre of Vojvodina, Emergency Internal Medicine Division

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

location_facility: University of Alberta - Zeidler Ledcor Centre

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet Gasztroenterologiai Tanszek

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Houston Hospital for Specialized Surgery (Endoscopy only)

location_facility: East Ann Arbor Health and Geriatrics Center - UMHS

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology

location_facility: ECG Unit of West Tallinn Central Hospital

location_facility: Non-State Healthcare Institution "Road Clinical Hospital at the station Samara"

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: Baylor College of Medicine - Baylor Medical Center (Drug Storage)

location_facility: Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych, Szpital Uniwersytecki nr 2 im

location_facility: Municipal Institution "City Hospital #7", Zaporizhzhia State Medical University

location_facility: Minicipal Institution City Hospital 7, Therapevtic Department,

location_facility: Regional Gastroenterology Associates of Lancaster, Ltd.

location_facility: Professional Quality Research, Inc.- Austin Gastroenterology PA

location_facility: ECG room Clinic Linezers (ECG only) Riga East University Hospital

location_facility: East Tallinn Central Hospital Internal Medical Clinic

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: AOU Mater Domini - U.O. Fisiopatologia Digestiva

location_facility: Baylor College of Medicine (Baylor Medical Center)

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

location_facility: Kyiv Municipal Clinical Hospital #18, Proctology Department

location_facility: Municipal Budget Institution of Healthcare of Novosibirsk " City Clinical Hospital No 12"

location_facility: Shiga University of Medical Science Hospital

location_facility: Hopital Saint Louis - Service d'hepato-gastoenterologie

location_facility: Department of Gastroenterology, Old Building

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology

location_facility: Klinika Chorob Wewnetrznych i Gastroenterologii z

location_facility: University Medical Center Groningen (UMCG)

location_facility: Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem

location_facility: Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2,

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Citrus Surgery & Endoscopy Center (colonoscopy)

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Regional Municipal Institution Chernivtsi Regional Clinical Hospital,

location_facility: Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.

location_facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III

location_facility: Chris Hani Baragwanath Academic Hospital

location_facility: Peterfy Sandor Utcai Korhaz Rendelointezet es Baleseti Kozpont

location_facility: Hospital Universitari de Bellvitge, Servicio de Digestivo

location_facility: Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,

location_facility: The North West London Hospitals NHS Trust

location_facility: Connecticut Clinical Research Foundation

location_facility: NYU Langone Nassau Gastroenterology Associates

location_facility: Medical Science Research Building 1 - UMHS

location_facility: Addenbrooke's Hospital-Cambridge University Hospitals NHS Foundation Trust

location_facility: State Budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.

location_facility: Oddzial Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital

location_facility: Federal state Institution "Sibirian regional Medical centre of Federal Medicobiologic Agency",

location_facility: Saint Joseph Mercy Hospital Outpatient Laboratory

location_facility: Spitalul Universitar de Urgenta Bucharest

location_facility: London Health Sciences Centre - University Hospital

location_facility: Bekes Megyei Pandy Kalman Korhaz III. Gasztroenterologiai Osztaly

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: Cabinet Particular Policlinic Algomed Srl

location_facility: X- Ray Department of West Tallinn Central Hospital

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Dr Rethy Pal Korhaz-Rendelointezet, III Belgyogyaszat


title: Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer

acronym: LAPC

summary: The purpose of this study is to determine whether patients with locally advanced pancreatic cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Poland
Romania
United Kingdom
Ireland
Austria
Australia
Italy
Canada
Czech Republic
Russian Federation
Hungary
United States
France
Belgium
Germany


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis on Background of Cyclophosphamide or Rituximab Treatment

summary: The aim of this trial is to optimize the treatment to induce remission for patients with non-life-threatening anti-neutrophil cytoplasmic antibody vasculitis (AAV). The intent is to reduce the toxicity of induction therapy by reducing the overall exposure to or eliminating entirely the use of systemic corticosteroids during the induction period with an inhibitor of the complement C5a receptor plus cyclophosphamide or rituximab.

ReferenceCitation: Cravedi P, Leventhal J, Lakhani P, Ward SC, Donovan MJ, Heeger PS. Immune cell-derived C3a and C5a costimulate human T cell alloimmunity. Am J Transplant. 2013 Oct;13(10):2530-9. doi: 10.1111/ajt.12405. Epub 2013 Sep 6.

lead_sponsor: ChemoCentryx

location_country:
Poland
United Kingdom
Austria
Netherlands
Sweden
Hungary
France
Belgium
Germany
Czechia


title: A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

lead_sponsor: Astellas Pharma Global Development, Inc.

source: euctr

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Taiwan
Spain
Ireland
Italy
Australia
Korea, Republic of
United States
France
China
Turkey
Japan

location_facility: MultiCare Regional Cancer Center - Gig Harbor

location_facility: Cancer Treatment Centers of America, Chicago

location_facility: Cancer Treatment Centers of America at Eastern Regional Medical Center

summary:
The purpose of this study is to confirm the recommended phase 2 dose (RP2D) of zolbetuximab in combination with Nab-P + GEM, determine overall survival and assess the safety and tolerability of the combination treatment.

This study will also evaluate tumor markers and pharmacokinetics (PK) of zolbetuximab, Nab-P and GEM, and health-related quality of life (HRQoL).


title: A Phase III, Randomized, Double-blind, Placebo-controlled, Parallel Group Safety and Efficacy Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) During 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycemic Control on MDI Insulin Regimen Alone or With Metformin

summary: This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.

ReferenceCitation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsäßer A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

ReferenceCitation: Rosenstock J, Jelaska A, Frappin G, Salsali A, Kim G, Woerle HJ, Broedl UC; EMPA-REG MDI Trial Investigators. Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes. Diabetes Care. 2014 Jul;37(7):1815-23. doi: 10.2337/dc13-3055. Epub 2014 Jun 14.

location_country:
Belgium
Spain
Russian Federation
Mexico
Finland
Czech Republic
Ukraine
Guatemala
United States
France
Peru
Colombia
Germany
Bulgaria

location_facility: 1245.49.10023 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.50203 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10019 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.70008 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.70010 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.72002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.42003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.32014 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.57003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.57006 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.75016 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34041 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10022 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.72003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.75007 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.49102 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52006 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.50202 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33001 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.51001 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52012 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.51006 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34016 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10024 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52004 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10001 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.75013 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33010 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34039 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10030 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34038 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10033 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.75014 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52005 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52011 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.75015 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33012 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52010 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.51002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33011 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10009 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10006 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52009 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10013 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52001 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.49002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34045 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.32007 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.59004 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.50204 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10026 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34043 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.42013 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10021 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.49101 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.57002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.49005 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.57005 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.72001 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34047 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.42011 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10016 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33004 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10007 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.50205 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33008 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.59003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10032 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.50201 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.57004 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10004 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.42012 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.32002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.42009 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10031 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10025 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10005 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52008 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10015 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.59001 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.32012 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.51008 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34044 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10011 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.49104 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.42010 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33009 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10014 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33007 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10018 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10020 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.51009 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.70006 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.32010 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.32013 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.49013 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.70009 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.51010 Boehringer Ingelheim Investigational Site


title: A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease

summary: This is a randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A as compared to placebo over 12 weeks in adult subjects with moderately-to-severely active Crohn's disease. Efficacy will be assessed by proportion of subjects achieving response, defined as a decrease in Crohn's Disease Activity Index (CDAI) score of at least 100 points (clinical response). Clinical remission (CDAI score less than 150 points) will be evaluated as a key secondary endpoint. Safety will be assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram (ECG). Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form-36 version 2 (SF-36v2), EQ-5D and Work Productivity and Activity Impairment-CD (WPAI-CD) and receipt of disability.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
South Africa
Czechia
Poland
Austria
Australia
Israel
Norway
Sweden
Slovakia
Canada
Hungary
Germany
Denmark
New Zealand
Korea, Republic of
France
Netherlands


title: A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance, Safety, and Tolerability of SAR110894D at the Doses of 0.5 mg, 2 mg, and 5 mg/Day for 24 Weeks in Patients With Mild to Moderate Alzheimer's Disease on Stable Donepezil Therapy

summary:
Primary Objective:

- To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) in comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's disease (AD) while on stable donepezil therapy

Secondary Objectives:

To explore the effect of SAR110894 on functional impairment, global clinical status and behavioral disturbances;
To assess the safety/tolerability of SAR110894;
To assess pharmacokinetic (PK) of SAR110894 and concentrations of donepezil;
To explore caregiver time consumption and distress changes.

ReferenceCitation: McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11:CD009178. doi: 10.1002/14651858.CD009178.pub4.

ReferenceCitation: Leger D, Elbaz M, Dubois A, Rio S, Mezghiche H, Carita P, Stemmelin J, Strauss M. Alzheimer's Disease Severity is Not Significantly Associated with Short Sleep: Survey by Actigraphy on 208 Mild and Moderate Alzheimer's Disease Patients. J Alzheimers Dis. 2017;55(1):321-331.

lead_sponsor: Sanofi

location_country:
Poland
Portugal
Spain
Italy
Australia
Canada
United States
France
Germany

location_facility:
Investigational Site Number 124014
Investigational Site Number 250003
Investigational Site Number 380002
Investigational Site Number 620002
Investigational Site Number 840001
Investigational Site Number 276009
Investigational Site Number 840006
Investigational Site Number 616002
Investigational Site Number 276011
Investigational Site Number 840012
Investigational Site Number 840008
Investigational Site Number 036009
Investigational Site Number 840040
Investigational Site Number 380006
Investigational Site Number 124009
Investigational Site Number 250008
Investigational Site Number 276008
Investigational Site Number 124015
Investigational Site Number 036008
Investigational Site Number 840031
Investigational Site Number 840037
Investigational Site Number 380005
Investigational Site Number 380001
Investigational Site Number 124004
Investigational Site Number 380003
Investigational Site Number 840030
Investigational Site Number 840004
Investigational Site Number 840021
Investigational Site Number 840039
Investigational Site Number 840034
Investigational Site Number 124008
Investigational Site Number 250002
Investigational Site Number 724007
Investigational Site Number 276007
Investigational Site Number 840025
Investigational Site Number 840013
Investigational Site Number 724002
Investigational Site Number 250006
Investigational Site Number 036001
Investigational Site Number 840038
Investigational Site Number 250005
Investigational Site Number 616004
Investigational Site Number 616003
Investigational Site Number 840009
Investigational Site Number 616005
Investigational Site Number 840011
Investigational Site Number 616006
Investigational Site Number 124013
Investigational Site Number 840024
Investigational Site Number 724001
Investigational Site Number 380004
Investigational Site Number 840032
Investigational Site Number 724003
Investigational Site Number 036005
Investigational Site Number 616001
Investigational Site Number 036007
Investigational Site Number 840018
Investigational Site Number 036003
Investigational Site Number 124003
Investigational Site Number 276012
Investigational Site Number 840015
Investigational Site Number 840026
Investigational Site Number 124011
Investigational Site Number 124001
Investigational Site Number 036006
Investigational Site Number 840002
Investigational Site Number 124002
Investigational Site Number 250007
Investigational Site Number 840005
Investigational Site Number 036004
Investigational Site Number 840003
Investigational Site Number 250004
Investigational Site Number 276001
Investigational Site Number 724008
Investigational Site Number 840014
Investigational Site Number 124010
Investigational Site Number 250009
Investigational Site Number 250001
Investigational Site Number 124006
Investigational Site Number 036002
Investigational Site Number 620001
Investigational Site Number 840041


title: A Phase 3 Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) Fixed-dose Regimen in Virologically Suppressed, HIV-1 Infected Patients

summary:
The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment option to patients who wish to simplify dosing by reducing pill burden or to improve the tolerability of their treatment.

Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which participants will switch treatment regimens at the start of the study, and the Stay on Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their baseline regimen during the first 24 weeks of the study (designed to provide an initial active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit.

After the 48-week study analysis period, participants may continue to receive the FTC/RPV/TDF STR per protocol before switching to a commercially available source.

location_country:
Spain
Italy
Austria
United Kingdom
Canada
Puerto Rico
United States
France
Belgium
Germany

location_facility: Chelsea and Westminster Hospital Foundation Trust

location_facility: Hôpital Saint Antoine, Servuce de Maladies Infectieuses

location_facility: Department of Infectious Diseases, Saint-Louis hospital

location_facility: University of Cologne, Department of Internal Medicine

location_facility: Infectious Disease Specialists of Atlanta (IDSA)

location_facility: Johns Hopkins University School of Medicine

location_facility: Archet 1 CHU de Nice - 6ème Niveau - Infectiology

location_facility: La Playa Medical Group and Clinical Research

location_facility: Dept. of Dermatology, Div. of Immunology,

location_facility: National Institute for Infectious Diseases "L. Spallanzani" IRCCS

location_facility: Center for HIV and Hepatogastroenterology

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Tarrant County Infectious Diseases Associates

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

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: Downtown Infectious Disease Clinic - Univ of BC

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: University Medical Center Hamburg - Eppendorf

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Infectiologie - 7ème Ouest - CHU HOTEL DIEU

location_facility: University of Bonn, Dep. of Internal Medicine I, HIV-Outpatient Clinic

location_facility: Azienda Ospedaliera San Paolo, Mallattie Infettive e Tropicali

location_facility: Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive

location_facility: University of South Florida - HIV Clinical Research Unit

location_facility: 2.Interne Lungenabteilung Otto Wagner Spital

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: AIDS Healthcare Foundation-Research Center


title: A Phase III Randomized, Open-label Study Comparing GSK1120212 to Chemotherapy in Subjects With Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma

summary: This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample. Subjects who have received up to one prior regimen of chemotherapy in the advanced or metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1 randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy arm). The primary endpoint for the statistical analysis will be a comparison of progression free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have progression on chemotherapy will be offered the option to receive GSK1120212.

ReferenceCitation: Flaherty KT, Robert C, Hersey P, Nathan P, Garbe C, Milhem M, Demidov LV, Hassel JC, Rutkowski P, Mohr P, Dummer R, Trefzer U, Larkin JM, Utikal J, Dreno B, Nyakas M, Middleton MR, Becker JC, Casey M, Sherman LJ, Wu FS, Ouellet D, Martin AM, Patel K, Schadendorf D; METRIC Study Group. Improved survival with MEK inhibition in BRAF-mutated melanoma. N Engl J Med. 2012 Jul 12;367(2):107-14. doi: 10.1056/NEJMoa1203421. Epub 2012 Jun 4.

ReferenceCitation: Robert C, Flaherty K, Nathan P, Hersey P, Garbe C, Milhem M, Demidov L, Mohr P, Hassel JC, Rutkowski P, Dummer R, Utikal J, Kiecker F, Larkin J, D'Amelio A Jr, Mookerjee B, Schadendorf D. Five-year outcomes from a phase 3 METRIC study in patients with BRAF V600 E/K-mutant advanced or metastatic melanoma. Eur J Cancer. 2019 Mar;109:61-69. doi: 10.1016/j.ejca.2018.12.015. Epub 2019 Jan 25.

ReferenceCitation: Latimer NR, Bell H, Abrams KR, Amonkar MM, Casey M. Adjusting for treatment switching in the METRIC study shows further improved overall survival with trametinib compared with chemotherapy. Cancer Med. 2016 May;5(5):806-15. doi: 10.1002/cam4.643. Epub 2016 Jan 27.

ReferenceCitation: Santiago-Walker A, Gagnon R, Mazumdar J, Casey M, Long GV, Schadendorf D, Flaherty K, Kefford R, Hauschild A, Hwu P, Haney P, O'Hagan A, Carver J, Goodman V, Legos J, Martin AM. Correlation of BRAF Mutation Status in Circulating-Free DNA and Tumor and Association with Clinical Outcome across Four BRAFi and MEKi Clinical Trials. Clin Cancer Res. 2016 Feb 1;22(3):567-74. doi: 10.1158/1078-0432.CCR-15-0321. Epub 2015 Oct 7.

ReferenceCitation: Schadendorf D, Amonkar MM, Milhem M, Grotzinger K, Demidov LV, Rutkowski P, Garbe C, Dummer R, Hassel JC, Wolter P, Mohr P, Trefzer U, Lefeuvre-Plesse C, Rutten A, Steven N, Ullenhag G, Sherman L, Wu FS, Patel K, Casey M, Robert C. Functional and symptom impact of trametinib versus chemotherapy in BRAF V600E advanced or metastatic melanoma: quality-of-life analyses of the METRIC study. Ann Oncol. 2014 Mar;25(3):700-706. doi: 10.1093/annonc/mdt580. Epub 2014 Feb 6.

location_country:
Poland
United Kingdom
Greece
Austria
Australia
Italy
Argentina
Canada
New Zealand
Russian Federation
Sweden
Switzerland
Ukraine
United States
France
Belgium
Norway
Germany
Czechia


title: A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

summary: The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.

ReferenceCitation: Sarrazin C, Dierynck I, Cloherty G, Ghys A, Janssen K, Luo D, Witek J, Buti M, Picchio G, De Meyer S. An OPTIMIZE study retrospective analysis for management of telaprevir-treated hepatitis C virus (HCV)-infected patients by use of the Abbott RealTime HCV RNA assay. J Clin Microbiol. 2015 Apr;53(4):1264-9. doi: 10.1128/JCM.03030-14. Epub 2015 Feb 4.

ReferenceCitation: Buti M, Agarwal K, Horsmans Y, Sievert W, Janczewska E, Zeuzem S, Nyberg L, Brown RS Jr, Hézode C, Rizzetto M, Paraná R, De Meyer S, De Masi R, Luo D, Bertelsen K, Witek J. Telaprevir twice daily is noninferior to telaprevir every 8 hours for patients with chronic hepatitis C. Gastroenterology. 2014 Mar;146(3):744-753.e3. doi: 10.1053/j.gastro.2013.11.047. Epub 2013 Dec 4.

lead_sponsor: Janssen Infectious Diseases BVBA

location_country:
Poland
Brazil
Spain
Ireland
Austria
Australia
Mexico
United Kingdom
Sweden
United States
France
Belgium
Germany


title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-α] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid Treatment

summary: Phase IIb study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis.

ipd_sharing: Undecided

lead_sponsor: Abivax S.A.

location_country:
Poland
Belarus
Serbia
Italy
Austria
Slovenia
Spain
Canada
United Kingdom
Ukraine
Hungary
United States
France
Belgium
Germany
Slovakia
Czechia

location_facility: Nottingham University Hospitals Queen's Medical Centre

location_facility: CI City Clinical Hospital #6 Dept of Gastroenterology

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

location_facility: Szpital Uniwersytecki nr 2 im.dr J. Biziela

location_facility: Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

location_facility: Allen Whey Khye Lim Professional Corporation

location_facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia

location_facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Atlanta Center for Gastroenterology, P.C

location_facility: CNE Cherkasy Regional Hospital of Cherkasy Regional Council

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Clinical Center " Dr Dragisa Misovic Dedinje"

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Ordensklinikum Linz GmbH - Barmherzige Schwestern

location_facility: Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt

location_facility: I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

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

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

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

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

location_facility: Vitebsk regoinal clinical specialized center

location_facility: Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU

location_facility: Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

location_facility: A. Novak Transcarpathian Regional Clinical Hospital