title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

acronym: Yosemite

summary:
The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

lead_sponsor: Gilead Sciences

location_country:
Germany
Poland
Australia
Japan
Czechia
France
Portugal
Hungary
United States
Romania
Italy
United Kingdom
Singapore
Sweden
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

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

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Gemeinschaftspraxis Dres. Söling Und Siehl

location_facility: Florida Cancer Specialists and Research Institute

location_facility: Froedtert Hospital and Medical College of Wisconsin

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Kobe City Medical Center General Hospital

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Hadassah Medical Organization, Ein Kerem

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Saint Petersburg I.P. Pavlov State Medical University

location_facility: Debreceni Egyetem Orvos-és Egészségtudományi Centrum

location_facility: FSI "V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies"

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Azienda Ospedaliero Universitaria (AOU) "Maggiore della Carita" di Novara

location_facility: Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie

location_facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim

location_facility: Haematology and Oncology Clinics of Australia at Chermside

location_facility: Hospital Geral de Santo António do Centro Hospitalar do Porto

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko

location_facility: Center for Cancer and Blood Disorders, PC

location_facility: Centro di Riferimento Oncologico di Aviano


type: Other Identifier

type: Registry Identifier

type: EudraCT Number

title: A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022)

summary:
The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy.

The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Australia
Brazil
Japan
Thailand
Turkey
Chile
Czechia
Canada
France
Colombia
Hungary
United States
Romania
China
Malaysia
Italy
United Kingdom
Singapore
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Israel

location_facility: Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2405)

location_facility: University of Rochester Medical Center ( Site 3528)

location_facility: Tallaght University Hospital ( Site 1402)

location_facility: Washington University-Internal Medicine/Oncology ( Site 3531)

location_facility: INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1902)

location_facility: Hospital Civil Fray Antonio Alcalde-Oncology ( Site 1906)

location_facility: Georgetown University Medical Center ( Site 3534)

location_facility: MHAT Serdika-Second Department of Medical Oncology ( Site 0203)

location_facility: Chongqing University Cancer Hospital ( Site 0414)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 3539)

location_facility: CHU Besançon-Medical oncology ( Site 0904)

location_facility: Centro de Investigacion Clinica de Oaxaca ( Site 1904)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2307)

location_facility: Universitaetsklinikum des Saarlandes-Klinik fuer Urologie und Kinderurologies ( Site 1020)

location_facility: Hospital Clinico San Carlos-Oncology Department ( Site 2703)

location_facility: Ege University Medicine of Faculty-Medical Oncology ( Site 3202)

location_facility: BP - A Beneficencia Portuguesa de São Paulo ( Site 0111)

location_facility: Euromedica General Clinic Thessaloniki-Oncology Unit ( Site 1103)

location_facility: University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3518)

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S

location_facility: Seoul National University Bundang Hospital-Urology ( Site 2602)

location_facility: Auckland City Hospital-Cancer & Blood Research ( Site 2003)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 2802)

location_facility: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2710)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 2801)

location_facility: The Second Affiliated Hospital of Nanchang University ( Site 0443)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 3002)

location_facility: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1608)

location_facility: National Taiwan University Hospital ( Site 2904)

location_facility: Tianjin Medical University Cancer Institute and Hospital ( Site 0422)

location_facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2302)

location_facility: Hospital de Clínicas de Ribeirão Preto ( Site 0112)

location_facility: BC Cancer Vancouver-Clinical Trials Unit ( Site 3707)

location_facility: Isala, locatie Zwolle-Oncology ( Site 3111)

location_facility: Fox Chase Cancer Center-GU Oncology ( Site 3535)

location_facility: Amphia Ziekenhuis, locatie Breda Molengracht ( Site 3103)

location_facility: Sarawak General Hospital-Radiotherapy Unit ( Site 1805)

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 2315)

location_facility: Nippon Medical School Hospital ( Site 1705)

location_facility: Huadong Hospital Affiliated to Fudan University ( Site 0405)

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 0402)

location_facility: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1022)

location_facility: Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 0002)

location_facility: Oulun yliopistollinen sairaala ( Site 0802)

location_facility: A.O.U.C. Policlinico di Bari ( Site 1607)

location_facility: Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0205)

location_facility: Beijing Cancer hospital-Urinary Surgery ( Site 0406)

location_facility: Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 0418)

location_facility: Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 0603)

location_facility: Sourasky Medical Center-Oncology ( Site 1501)

location_facility: Azienda Ospedaliera Santa Maria Terni-SC Oncologia ( Site 1609)

location_facility: CENTRE LEON BERARD-Medical oncology ( Site 0902)

location_facility: Moores Cancer Center-Clinical Trials Office- Genitourinary ( Site 3516)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2306)

location_facility: Tokyo Women's Medical University Adachi Medical Center ( Site 1717)

location_facility: Victoria Hospital & Children's Hospital - London Health Scie-London Regional Cancer Program ( Site 3

location_facility: Fiona Stanley Hospital-Medical Oncology ( Site 0004)

location_facility: Haga Ziekenhuis locatie Leyweg-Oncology ( Site 3108)

location_facility: Army Medical Center of People's Liberation Army ( Site 0439)

location_facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1101)

location_facility: Universitaetsklinikum Tuebingen ( Site 1002)

location_facility: Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1310)

location_facility: St. Vincent's University Hospital ( Site 1401)

location_facility: Alexandra Hospital-ONCOLOGY DEPT. ( Site 1102)

location_facility: National Cancer Center-Center for Urologic Cancer ( Site 2604)

location_facility: Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0607)

location_facility: Rabin Medical Center-Oncology ( Site 1503)

location_facility: BRCR Global Mexico - Queretaro-SMIQ ( Site 1907)

location_facility: European Interbalkan Medical Center-Oncology Department ( Site 1105)

location_facility: Tampereen yliopistollinen sairaala ( Site 0805)

location_facility: National University Hospital ( Site 3602)

location_facility: Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 3524)

location_facility: Hospital H+ Queretaro-Cuidados Oncológicos ( Site 1905)

location_facility: McGill University Health Centre ( Site 3709)

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 3515)

location_facility: Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 2803)

location_facility: Instituto do Câncer e Transplante de Curitiba ( Site 0102)

location_facility: Cancer and Hematology Centers of Western Michigan ( Site 3502)

location_facility: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0803)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran-Oncologia y Hematologia ( Site 1

location_facility: Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 0602)

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

location_facility: Universitaetsklinikum Duesseldorf ( Site 1017)

location_facility: The First Affiliated Hospital of Nanchang University ( Site 0432)

location_facility: Fudan University Shanghai Cancer Center-Urology department ( Site 0401)

location_facility: University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 35

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 3710)

location_facility: Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0601)

location_facility: Hokkaido University Hospital ( Site 1701)

location_facility: University of Texas MD Anderson Cancer Center-Urology ( Site 3569)

location_facility: Hacettepe Universitesi-oncology hospital ( Site 3203)

location_facility: CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 3708)

location_facility: Massachusetts General Hospital ( Site 3571)

location_facility: Peking University First Hospital-Urology ( Site 0407)

location_facility: Hamamatsu University Hospital ( Site 1708)

location_facility: Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 0438)

location_facility: Kagoshima University Hospital ( Site 1719)

location_facility: Nara Medical University Hospital ( Site 1712)

location_facility: University Medical Center Groningen ( Site 3121)

location_facility: National Cancer Center Hospital East ( Site 1704)

location_facility: iCan Oncology Center Centro Medico AVE ( Site 1901)

location_facility: Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 1001)

location_facility: Hubei Cancer Hospital-Urinary surgery ( Site 0419)

location_facility: Toho University Sakura Medical Center ( Site 1718)

location_facility: Tongji Hospital Tongji Medical,Science & Technology-oncology ( Site 0423)

location_facility: Universitaetsklinikum Essen ( Site 1004)

location_facility: Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 2905)

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 3550)

location_facility: Second Affiliated hospital of Anhui Medical University-Urology ( Site 0416)

location_facility: Henan Cancer Hospital-Urology ( Site 0441)

location_facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 3

location_facility: Centre Hospitalier Universitaire d'Angers-Urology ( Site 0901)

location_facility: Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0604)

location_facility: Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center- GU Oncology ( Site 3549)

location_facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0903)

location_facility: Hegau-Bodensee-Klinikum Singen ( Site 1016)

location_facility: Hadassah Medical Center-Oncology ( Site 1506)

location_facility: Tamworth Hospital-North West Cancer Centre ( Site 0006)

location_facility: Mayo Clinic in Arizona - Phoenix ( Site 3554)

location_facility: St. Vincent Frontier Cancer Center-Research ( Site 3506)

location_facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro

location_facility: City of Hope Comprehensive Cancer Center ( Site 3567)

location_facility: Administradora Country S.A. - Clinica del Country ( Site 0504)

location_facility: Terapias Integrales del Riñon SA de CV ( Site 1910)

location_facility: Ankara University Hospital Cebeci ( Site 3209)

location_facility: Tri-Service General Hospital ( Site 2908)

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University ( Site 0431)

location_facility: Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0906)

location_facility: The West Clinic, PLLC dba West Cancer Center ( Site 3522)

location_facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 0908)

location_facility: Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1403)

location_facility: Krankenhaus Martha-Maria Halle-Dölau-Klinik für Urologie, Kinderurologie und urologische Onkologie (

location_facility: Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 2906)

location_facility: Universitätsklinikum Aachen ( Site 1024)

location_facility: Ospedale San Raffaele-Oncologia Medica ( Site 1606)

location_facility: Asan Medical Center-Oncology ( Site 2601)

location_facility: Parkview Research Center at Parkview Regional Medical Center ( Site 3526)

location_facility: Beatson West of Scotland Cancer Centre-Clinical Trials Unit ( Site 3305)

location_facility: BRCR Global Mexico - Guadalajara-Research ( Site 1908)

location_facility: Spaarne Gasthuis - Hoofddorp-Oncology ( Site 3107)

location_facility: Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 1005)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 3541)

location_facility: Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu M-chemotherapy department ( Site 2312)

location_facility: Okayama University Hospital ( Site 1720)

location_facility: The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 0403)

location_facility: National Cancer Centre Singapore ( Site 3601)

location_facility: Hospital Universitario Virgen de la Victoria-Phase II-III-IV Trials ( Site 2709)

location_facility: Petz Aladar Egyetemi Oktato Korhaz-Onkológiai Osztály ( Site 1321)

location_facility: Zhejiang Provincial People's Hospital-Urology ( Site 0426)

location_facility: China Medical University Hospital-Department of Urology ( Site 2907)

location_facility: Sapporo Medical University Hospital ( Site 1702)

location_facility: Cancer Hospital Chinese Academy of Medical Science-Urinary Surgery ( Site 0435)

location_facility: Ankara City Hospital-Medical Oncology ( Site 3206)

location_facility: Taichung Veterans General Hospital ( Site 2902)

location_facility: The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 0445)

location_facility: Hospital Lucus Augusti-Oncology ( Site 2706)

location_facility: Tergooiziekenhuizen, locatie Hilversum ( Site 3102)

location_facility: Azienda USL 8 di Arezzo-Medical Oncology ( Site 1610)

location_facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2313)

location_facility: Inova Schar Cancer Institute ( Site 3525)

location_facility: The Christie NHS Foundation Trust ( Site 3301)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 3568)

location_facility: UT Southwestern Medical Center ( Site 3529)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3201)

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 1021)

location_facility: Haaglanden MC - locatie Antoniushove ( Site 3117)

location_facility: Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1311)

location_facility: Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2401)

location_facility: Kuopion Yliopistollinen Sairaala-Syöpäkeskus ( Site 0804)

location_facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0103)

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga-SCDU Oncologia Medica ( Site 1602)

location_facility: West China Hospital of Sichuan University-Urology Surgery ( Site 0410)

location_facility: Kaohsiung Veterans General Hospital ( Site 2901)

location_facility: Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 3207)

location_facility: Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0606)

location_facility: Institut Català d'Oncologia (ICO) - Girona ( Site 2707)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 2303)

location_facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2702)

location_facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE-Urology Surgery ( Site 0417)

location_facility: University of Colorado Anschutz Medical Campus ( Site 3514)

location_facility: Ningbo First Hospital-Urology ( Site 0433)

location_facility: Austin Health-Cancer Clinical Trials Centre ( Site 0005)

location_facility: Helios Klinikum Berlin-Buch ( Site 1011)

location_facility: James Lind Centro de Investigación del Cáncer ( Site 0307)

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1319)

location_facility: Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1316)

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1603)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1604)

location_facility: Macquarie University-MQ Health Clinical Trials Unit ( Site 0003)

location_facility: IRCCS - AOU di Bologna-Oncologia Medica Ardizzoni ( Site 1605)

location_facility: Ziekenhuis Rijnstate-Rijnstate Centrum Oncologisch Onderzoek ( Site 3113)

location_facility: Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si

location_facility: Hospital São Carlos-Oncocentro Ce ( Site 0104)

location_facility: Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0101)

location_facility: MBAL Uni Hospital-Department of Medical Oncology ( Site 0204)

location_facility: The First Affiliated Hospital, Zhejiang University ( Site 0428)

location_facility: The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 0425)

location_facility: Sheba Medical Center-ONCOLOGY ( Site 1504)

location_facility: Maxima Medisch Centrum, locatie Eindhoven ( Site 3116)

location_facility: Metropolitan Hospital-2nd Oncology Dept ( Site 1104)

location_facility: Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0605)

location_facility: St. Antonius Ziekenhuis, locatie Utrecht-Interne geneeskunde ( Site 3112)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 2309)

location_facility: Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2708)

location_facility: First Medical Center of Chinese PLA General Hospital ( Site 0415)

location_facility: Rambam Health Care Campus-Oncology ( Site 1502)

location_facility: Lyell McEwin Hospital-Oncology Clinical Trials Unit ( Site 0008)

location_facility: Wakayama Medical University Hospital ( Site 1721)

location_facility: Istanbul Universitesi Cerrahpasa-Internal Diseases ( Site 3204)

location_facility: University Malaya Medical Centre ( Site 1804)

location_facility: Taipei Veterans General Hospital ( Site 2903)

location_facility: Centro de Oncología Personalizada ( Site 1911)

location_facility: Englewood Hospital and Medical Center ( Site 3557)

location_facility: MICS Centrum Medyczne Torun ( Site 2305)

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 3208)

location_facility: Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 3106)

location_facility: Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 3572)

location_facility: klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit

location_facility: Centro Avançado de Tratamento Oncológico- CENANTRON-Clinical Research ( Site 0105)

location_facility: St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3307)

location_facility: St. Mary's Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado-St. Mary's ( S

location_facility: Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 3101)

location_facility: Fundación Instituto Valenciano de Oncología ( Site 2705)

location_facility: City Hospital, Nottingham University Hospitals ( Site 3303)

location_facility: Princess Margaret Cancer Centre ( Site 3703)

location_facility: Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1601)

location_facility: Dana-Farber Cancer Institute-GU ( Site 3505)

location_facility: Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0505)

location_facility: Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 2311)

location_facility: Radiology Therapeutic Center-Oncology ( Site 2404)

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas

summary: A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas

ipd_sharing: No

lead_sponsor: Viracta Therapeutics, Inc.

location_country:
Germany
Italy
Israel
Hong Kong
Singapore
Australia
Brazil
United Kingdom
United States
Korea, Republic of
Spain
Malaysia
Taiwan
Canada
France

location_facility: CEPEVILLE - Instituto Joinvilense de Hematologia e Oncologia

location_facility: HCFMUSP - Hospital das Clínicas da Faculdade de Medicina Universidade de São Paulo

location_facility: The University of Alabama at Birmingham Comprehensive Cancer Center

location_facility: Ohio State University: Wexner Medical Center

location_facility: Hadassah Medical Center, Ein Kerem Hospital

location_facility: Klinik für Hämatologie und Onkologie, UKSH Campus Lübeck

location_facility: Mid Florida Hematology and Oncology Center

location_facility: John Theurer Cancer Center: Hackensack Univeristy

location_facility: Harold C. Simmons Comprehensive Cancer Center

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Queen Mary Hospital/University of Hong Kong

location_facility: CIPE Centro Internacional de Pesquisa - AC Camargo Cancer Center

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

location_facility: Centre Hospitalier Universitaire Limoges

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Memorial Sloan Kettering Cancer Center - New York

location_facility: Winship Cancer Institute of Emory University

location_facility: UCSF Hematology and Blood and Marrow Transplant

location_facility: Sidney Kimmel Cancer Center - Jefferson Health

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Sarawak General Hospital / Hospital Umum Sarawak

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Jimenez Diaz Foundation University Hospital

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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

location_facility: Chang Gung Memorial Hospital - Linkou Branch


summary:
The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).

Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.

Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.

Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS.

Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS.

ReferenceType: derived

ReferenceCitation: Rimner A, Lai WV, Califano R, Jabbour SK, Rudin CM, Faivre-Finn C, Cho BC, Kato T, Yu J, Chafin W, Yu L, Zhao B, Byers L. Rationale and Design of the Phase 3 KEYLYNK-013 Study of Pembrolizumab With Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Limited-Stage Small-Cell Lung Cancer. Clin Lung Cancer. 2022 Jul;23(5):e325-e329. doi: 10.1016/j.cllc.2022.04.005. Epub 2022 Apr 29.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

location_facility: VA Ann Arbor Healthcare System ( Site 0050)

location_facility: Institute for Oncology and Radiology of Serbia ( Site 2995)

location_facility: Memorial Sloan Kettering - Westchester-Thoracic Oncology ( Site 0134)

location_facility: Aichi Cancer Center Hospital ( Site 4010)

location_facility: Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 1812)

location_facility: Medical Oncology Associates, PS ( Site 0142)

location_facility: Memorial Sloan Kettering - Monmouth ( Site 0135)

location_facility: Steve Biko Academic Hospital ( Site 5000)

location_facility: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1105)

location_facility: Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0401)

location_facility: A O U Policlinico di Modena ( Site 1503)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 4011)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 1312)

location_facility: The First Hospital of Jilin University ( Site 3132)

location_facility: Saint Francis Cancer Center ( Site 0087)

location_facility: Loma Linda University Cancer Center ( Site 0011)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)

location_facility: The University of Tennessee Medical Center ( Site 0116)

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 1701)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 1301)

location_facility: Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2805)

location_facility: Törökbálinti Tüdőgyógyintézet ( Site 1304)

location_facility: Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 3140)

location_facility: Zhejiang Cancer Hospital.... ( Site 3108)

location_facility: St. Vincent Healthcare Frontier Cancer Center ( Site 0056)

location_facility: Providence Regional Cancer Partnership ( Site 0106)

location_facility: Institut De Cancerologie De L Ouest ( Site 1110)

location_facility: Nacionalinis Vezio Institutas ( Site 2300)

location_facility: University of Chicago Medical Center ( Site 0136)

location_facility: Texas Oncology - Dallas (Presbyterian)_McIntyre ( Site 0098)

location_facility: Kyiv City Clinical Oncology Center ( Site 2100)

location_facility: SA Tartu Ulikooli Kliinikum ( Site 2200)

location_facility: Hospital Universitari Vall d Hebron ( Site 1904)

location_facility: Policlinico Universitario Agostino Gemelli ( Site 1505)

location_facility: Fairview Hospital-Moll Cancer Center ( Site 0141)

location_facility: The Cancer Institute Hospital of JFCR ( Site 4006)

location_facility: Keimyung University Dongsan Hospital ( Site 3302)

location_facility: Hospital Regional Universitario de Malaga ( Site 1905)

location_facility: University General Hospital of Larisa ( Site 1201)

location_facility: Fort Wayne Medical Oncology and Hematology ( Site 0034)

location_facility: Fujian Provincial Cancer Hospital ( Site 3126)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 4000)

location_facility: The Christie NHS Foundation Trust ( Site 2405)

location_facility: CHU Grenoble -Hop Michallon ( Site 1102)

location_facility: Ironwood Cancer & Research Centers ( Site 0007)

location_facility: Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1704)

location_facility: Azienda Ospedaliera Spedali Civili di Brescia ( Site 1512)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 1401)

location_facility: Institut za plucne bolesti Vojvodine Sremska Kamenica ( Site 2991)

location_facility: Juntendo University Hospital ( Site 4008)

location_facility: Seoul National University Bundang Hospital ( Site 3301)

location_facility: The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3131)

location_facility: Taunton and Somerset Hospital ( Site 2404)

location_facility: Gold Coast University Hospital ( Site 3003)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0212)

location_facility: Memorial Sloan Kettering - Nassau ( Site 0131)

location_facility: Niigata Cancer Center Hospital ( Site 4004)

location_facility: Istituto Europeo di Oncologia ( Site 1501)

location_facility: McGill University Health Centre ( Site 0210)

location_facility: Second Xiangya Hospital of Central-South University ( Site 3128)

location_facility: Kobe Minimally Invasive Cancer Center ( Site 4003)

location_facility: West China Hospital of Sichuan University ( Site 3114)

location_facility: SA Pohja-Eesti Regionaalhaigla ( Site 2201)

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0202)

location_facility: Sverdlovsk Regional Oncology Hospital ( Site 1807)

location_facility: Osaka Medical and Pharmaceutical University Hospital ( Site 4007)

location_facility: Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 1705)

location_facility: Orszagos Onkologiai Intezet ( Site 1310)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0123)

location_facility: Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3113)

location_facility: Severance Hospital Yonsei University Health System ( Site 3304)

location_facility: Ankara Bilkent Sehir Hastanesi ( Site 2007)

location_facility: Xiangya Hospital of Central South University ( Site 3137)

location_facility: Hospital Universitario 12 de Octubre ( Site 1902)

location_facility: Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1907)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 3104)

location_facility: Memorial Sloan Kettering- Commack ( Site 0132)

location_facility: Peking Union Medical College Hospital ( Site 3102)

location_facility: Clinic of National Cancer Institute ( Site 2101)

location_facility: Memorial Sloan Kettering - Bergen ( Site 0130)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2003)

location_facility: IRCCS Istituto Oncologico Veneto ( Site 1506)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2009)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 3121)

location_facility: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)

location_facility: Hospital Universitario Central de Asturias ( Site 1900)

location_facility: The Second Affiliated Hospital of Nanchang University ( Site 3106)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2110)

location_facility: National Cancer Center Hospital ( Site 4015)

location_facility: CIUSSS de la Mauricie et du Centre du Quebec ( Site 0200)

location_facility: Spitalul Municipal Ploiesti ( Site 2801)

location_facility: Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1103)

location_facility: Guy s & St Thomas NHS Foundation Trust ( Site 2408)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 1509)

location_facility: C.I.U. Hopital Ambroise Pare ( Site 1001)

location_facility: Okayama University Hospital ( Site 4012)

location_facility: Osaka International Cancer Institute ( Site 4005)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1306)

location_facility: Peking University Shenzhen Hospital ( Site 3118)

location_facility: Harry & Jeanette Weinberg Cancer Institute ( Site 0045)

location_facility: Daping Hospital,Third Military Medical University ( Site 3136)

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0404)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 3303)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2803)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 3103)

location_facility: Ninewells Hospital and Medical School ( Site 2401)

location_facility: Istituto Nazionale dei Tumori ( Site 1504)

location_facility: MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1800)

location_facility: Anti-Cancer Hospital of Thessaloniki Theagenio ( Site 1204)

location_facility: Memorial Sloan Kettering - Basking Ridge ( Site 0133)

location_facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 1811)

location_facility: Multicare Institute For Research And Innovation ( Site 0108)

location_facility: Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0140)

location_facility: University of Kentucky Chandler Medical Center ( Site 0138)

location_facility: Inje University Haeundae Paik Hospital ( Site 3307)

location_facility: Sotiria Regional Chest Diseases Hospital of Athens ( Site 1200)

location_facility: Shandong Province Cancer Hospital ( Site 3100)

location_facility: IRCCS Ospedale San Raffaele ( Site 1500)

location_facility: University General Hospital of Herakleion ( Site 1202)

location_facility: Omsk Clinical Oncology Dispensary ( Site 1806)

location_facility: Western Health-Sunshine Hospital ( Site 3004)

location_facility: CHU UCL Namur Site de Godinne ( Site 1004)

location_facility: Kansai Medical University Hospital ( Site 4009)

location_facility: CHU de Bordeaux Hop St ANDRE ( Site 1115)

location_facility: Penn State Hershey Cancer Institute ( Site 0081)

location_facility: Tongji Medical College Huazhong University of Science and Technology ( Site 3138)

location_facility: Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0112)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0069)

location_facility: Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1814)

location_facility: Medipol Universite Hastanesi ( Site 2005)

location_facility: Texas Oncology - Dallas (Sammons) ( Site 0093)

location_facility: Frankston Hospital-Oncology and Haematology ( Site 3007)

location_facility: Moscow Regional Oncological Dispensary-Oncology (thoracic surgery) Department №1 ( Site 1815)

location_facility: Austin Health-Austin Hospital ( Site 3006)

location_facility: Shanghai Pulmonary Hospital ( Site 3101)

title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants With Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)

source: euctr

location_country:
Australia
Japan
Turkey
Canada
Serbia
France
Lithuania
Portugal
Hungary
United States
Ukraine
Romania
Belgium
China
Estonia
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
South Africa
Bulgaria
Russian Federation
Israel


lead_sponsor: Daiichi Sankyo, Inc.

summary: This is a study of the efficacy, pharmacokinetics, and safety of DS-1062a in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with known actionable genomic alterations.

sponsor_collaborators:
Daiichi Sankyo, Inc.
AstraZeneca

location_facility: Azienda Ospedaliero-Universitaria S. Orsola Malpighi

location_facility: Sarah Cannon Research Institute at Florida Cancer Center, North

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: National Koranyi Institute for TB and Pulmonology

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Azienda Ospedaliera Universitaria Policlinico-OVE

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur mer Hopital Sainte-Musse

location_facility: Sarah Cannon Research Institute at Florida Cancer Center, South

location_facility: Sarah Cannon Research Institute at Tennessee Oncology - Chattanooga

location_facility: XCancer / Regional Cancer Care Associate (Astera)

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Hospital General Universitario de Alicante

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Hopitaux Universitaire de Strasbourg- Nouvel Hopital Civil

location_facility: National Taiwan University Hospital NTUH

location_facility: University Hospitals Case Medical Center

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Azienda Ospedaliera Arcispedale Santa Maria

status: Active, not recruiting

title: Phase 2, Single-arm, Open-label Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations and Progressed On or After Applicable Targeted Therapy and Platinum Based Chemotherapy (TROPION-Lung05)

enrollment_type: Actual

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

location_country:
Germany
Italy
Hungary
Japan
Netherlands
United States
Korea, Republic of
Spain
Taiwan
France


intervention_type: Biological

acronym: Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

lead_sponsor: Takeda

summary: The main aim is to follow-up on long term side effect and symptom improvement of Darvadstrocel in the treatment of complex perianal fistula in adults. Participants will not receive any drug in this study.

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Virginia Mason Medical Center - Gastroenterology

location_facility: Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery

location_facility: Azienda Ospedaliero Universitaria S.Maria della Misericordia - Gastroenterologia

location_facility: Istituto Clinico Humanitas Rozzano, IRCCS - IBD Center

location_facility: MH Egeszsegugyi Kozpont - Gasztroenterologiai Osztaly

location_facility: University of Massachusetts - colon & rectal surgery

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

location_facility: Hopital Saint Louis - Gastro-hepatoenterologie

location_facility: North Shore University Hospital - Gastroenterology

location_facility: GZA ziekenhuizen - Campus Sint-Vincentius - Gastro-enterology

location_facility: University of Kansas Sxchool of Medicine

location_facility: University Surgical Associates-Rhode Island Hospital

location_facility: CHRU de Nancy -Hopital Brabois Adultes - Service d'Hepato- Gastroenterologie

location_facility: Penn State Hershey Medical Center - Surgery

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Hadassah Medical Organization, Hadassah Medical Center, Ein-

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: AOU Policlinico di Modena - Gastroenterologia

location_facility: USF Health South Tampa Center for Advanced Healthcare

location_facility: Shaare Zedek Medical Center - Gastroenterology

location_facility: Dartmouth Hitchcock Medical Center - Cancer Center

location_facility: Morristown Medical Center - Gastroenterology

location_facility: Medical College of Wisconsin Hub for Collaborative Medicine - Gastroenterology and Hepatology

location_facility: CHRU De Lille - Hopital Claude Huriez - Hepato-Gastro-Enterologie

location_facility: Barnes-Jewish Hospital - Gastroenterology

location_facility: Johns Hopkins Medicine - The Johns Hopkins Hospital

title: A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II Study

primary_purpose: Other

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

location_country:
Italy
Poland
Hungary
Israel
Belgium
United States
Spain
Czechia
France


lead_sponsor: Institut de Recherches Internationales Servier

summary: The purpose of this study was to evaluate the efficacity and the safety of bumetanide/S95008 in the improvement of Autism Spectrum Disorder core symptoms.

location_facility: Centro Hospitalar e Universitario de Coimbra Hospital Pediatrico

location_facility: Universidade Federal de São Paulo, Escola Paulista de Medicina

location_facility: Centre Hospitalier du Rouvray Centre de Ressources pour l'Autisme

location_facility: University hospital of Ostrava, Department of Psychiatry

location_facility: Hôpital Robert Debré Service de Psychiatrie de l'enfant et de l'adolescent

location_facility: Centre Hospitalier Charles Perrens CRA Aquitaine

location_facility: Magyar Református Egyház Bethesda Gyermekkórháza

location_facility: Trial Tech em Pesquisas com Medicamentos Ltda

location_facility: Neuro Riabilitazione/Psicopatologia dell'età evolutiva Istituto Scientifico Medea - Bosisio Parini

location_facility: U.O. di Neuropsichiatria Infantile Azienda Ospedaliera Universitaria Senese

location_facility: Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza Ospedale Pediatrico-Microcitemico

location_facility: Szegedi Tudományegyetem Szent-Gyorgy Albert Klinikai Kozpont Gyermekgyógyászati Klinika Gyermek es Ifjusagpszichiátriai o

location_facility: U.O.C. Psichiatria dello Sviluppo IRCCS Fondazione Stella Maris

location_facility: Hôpitaux Universitaires de Strasbourg Service de Psychiatrie de l'Enfant et de l'Adolescent

location_facility: Hospital General Universitario de Alicante

location_facility: Programma Interdipartimentale "Autismo 0-90" A.O.U. Policlinico "Gaetano Martino"

location_facility: Centrum Badań Klinicznych PI-House sp. z o.o

location_facility: Hôpital Le Vinatier CRA Rhône-Alpes, Bat 211

location_facility: Bekes Megyei Kozponti Korhaz Gyermek es ifjusagpszichiatriai osztaly

location_facility: "Niepubliczny Zakład Opieki Zdrowotnej Gdańskie Centrum Zdrowia Sp. z o.o.

location_facility: NAVICULA Centrum Diagnozy i Terapii Autyzmu w Łodzi

location_facility: Samodzielny Publiczny Dziecięcy Szpital Kliniczny w Warszawie Oddział Kliniczny Psychiatrii Wieku Rozwojowego

location_facility: National Institute of Children Diseases, Department of Child Psychiatry

location_facility: Institute of Neuropsychiatric Care, Department of Child Psychiatry

location_facility: The Winnicott Centre 195-197 Hathersage Road

location_facility: University Hospital Brno, Department of Child Neurology

location_facility: Clínica Neurológica e Neurocirúrgica de Joinville

location_facility: U.O. di Neuropsichiatria Infantile Fondazione Istituto Neurologico Nazionale Casimiro Mondino Istituto di Ricovero e Cura a Carattere Scientifico

location_facility: Faculdade de Medicina da Universidade de São Paulo - Departamento de psiquiatra

location_facility: Hospital Universitário Walter Cantídio-Universidade Federal do Ceará

status: Terminated

title: Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder. A 6-month Randomised, Double-blind, Placebo Controlled Multicentre Parallel Group Study to Evaluate Efficacy and Safety of Bumetanide 0.5mg Twice a Day Followed by an Open Label Active 6-month Treatment Period With Bumetanide (0.5mg Twice a Day) and a 6 Weeks Discontinuation Period After Treatment Stop.

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

Access can be requested for all interventional clinical studies:

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

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

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

study_completion_date_type: Actual

location_country:
Italy
Poland
Portugal
Slovakia
Hungary
United Kingdom
Australia
Brazil
United States
Spain
Czechia
France

status_simplified: Unknown


acronym: Dose Ranging, Switch Study of ISL and MK-8507 Once-Weekly

summary: This is a randomized, controlled, double-blind, study to evaluate the safety and tolerability of islatravir (ISL) + ulonivirine based on review of the accumulated safety data, in adult participants with human immunodeficiency virus type 1 (HIV-1) who have been virologically suppressed for ≥6 months on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) once-daily.

location_facility: CHUV (centre hospitalier universitaire vaudois) ( Site 2605)

location_facility: Chatham County Health Department ( Site 2707)

location_facility: Infectious Disease Specialists Of Atlanta PC ( Site 2704)

location_facility: CHU de Toulouse - Hopital Purpan ( Site 2302)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 2604)

location_facility: Triple O Research Institute, P.A. ( Site 2712)

location_facility: Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 2306)

location_facility: Universitaetsspital Zuerich ( Site 2601)

location_facility: DCOL Center for Clinical Research ( Site 2715)

location_facility: Saint Hope Foundation, Inc. ( Site 2716)

location_facility: Inselspital Universitaetsspital Bern ( Site 2603)

location_facility: Texas Centers for Infectious Disease Associates P.A. ( Site 2709)

location_facility: Centre Hospitalier Regional du Orleans ( Site 2304)

location_facility: Midway Immunology and Research ( Site 2713)

title: A Phase 2b, Randomized, Active-Controlled, Double-Blind, Dose-Ranging Clinical Study to Evaluate a Switch to Islatravir (ISL) and MK-8507 Once-Weekly in Adults With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once-Daily

location_country:
United States
Switzerland
France


lead_sponsor: AbbVie

summary:
Myelofibrosis (MF) is a rare blood cancer, notable for scarring of the bone marrow (the spongy tissue inside bones) and the spleen becoming larger. The purpose of this study is to assess safety and change in spleen volume when navitoclax is given in combination with ruxolitinib, compared to best available therapy, for adult participants with MF.

Navitoclax is an investigational drug (not yet approved) being developed for the treatment of MF. Participants in this study will be randomly selected (like picking numbers out of a hat) to be in 1 of 2 treatment arms. Neither participants nor the study doctor will be able to pick which treatment arm a participants enters. In Arm A, participants will receive navitoclax in combination with ruxolitinib. In Arm B, participants will receive the best available therapy (BAT) for MF. Adult participants with a diagnosis of MF that came back or did not get better after earlier treatment will be enrolled. Approximately 330 participants will be enrolled in approximately 210 sites across the world.

In Arm A, participants will receive navitoclax tablet by mouth once daily with by mouth ruxolitinib tablet twice daily. In Arm B, participants will receive the BAT available to the investigator. Participants will receive the study drug until they experience no benefit (determined by the investigator), participants cannot tolerate the study drugs, or participants withdraw consent. The approximate treatment duration is about 3 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.

location_facility: Azienda ULSS 8 Berica/Ospedale San Bortolo di Vicenza /ID# 221079

location_facility: Augusta University Georgia Cancer Center /ID# 219051

location_facility: Dana-Farber Cancer Institute /ID# 218998

location_facility: Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 221241

location_facility: Klinicki bolnicki centar Osijek /ID# 231503

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 221616

location_facility: Trakya University Medical Facu /ID# 224572

location_facility: Ondokuz mayis University Facul /ID# 224567

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 220969

location_facility: Northwest Oncology & Hematology - Elk Grove Village /ID# 222818

location_facility: Moscow State budget healthcare /ID# 221116

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 225731

location_facility: Virginia Cancer Specialists - Fairfax /ID# 223016

location_facility: Ege University Medical Faculty /ID# 224570

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 221077

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie /ID# 221160

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola /ID# 241031

location_facility: Hospital del Centro Comprensivo de Cancer de la UPR /ID# 223281

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 221041

location_facility: Linkou Chang Gung Memorial Hospital /ID# 218982

location_facility: St. Mary's Hospital Regional Cancer Center /ID# 224229

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 220914

location_facility: Ottawa Hospital Research Institute /ID# 238858

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 224617

location_facility: Stauferklinikum Schwaebisch Gmuend /ID# 223948

location_facility: Lux Med Onkologia - Szpital Szamocka /Id# 221265

location_facility: Assuta Ashdod Medical Center /ID# 225281

location_facility: Hospital Universitario Virgen del Rocio /ID# 221932

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 224673

location_facility: Tulane Medical Center - New Orleans /ID# 222940

location_facility: UMHAT Dr Georgi Stranski EAD /ID# 231650

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 221335

location_facility: Long Beach Memorial Medical Ct /ID# 224542

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 219090

location_facility: Dokkyo Medical University Saitama Medical Center /ID# 222334

location_facility: Border Medical Oncology Research Unit Albury Wodonga Regiona /ID# 223848

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 221124

location_facility: Tel Aviv Sourasky Medical Center /ID# 219135

location_facility: Wake Forest Baptist Medical Center /ID# 222899

location_facility: Ochsner Clinic Foundation-New Orleans /ID# 222777

location_facility: Aomori Prefectural Central Hospital /ID# 221778

location_facility: Hospital Universitario de Salamanca /ID# 221904

location_facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 220948

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 219087

location_facility: Centre Hospitalier de CHAMBERY /ID# 223771

location_facility: The Chaim Sheba Medical Center /ID# 219136

location_facility: Kanazawa University Hospital /ID# 223028

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 219061

location_facility: Kumamoto Shinto General Hospital /ID# 255645

location_facility: ASST Monza/Ospedale San Gerardo /ID# 225113

location_facility: Loyola University Medical Ctr /ID# 219048

location_facility: University of Yamanashi Hospital /ID# 221706

location_facility: Klinicki bolnicki centar Split /ID# 230800

location_facility: Uniwersyteckie Centrum Kliniczne /ID# 221298

location_facility: Klinikum Wels-Grieskirchen GmbH /ID# 220915

location_facility: Almazov National Medical Research Centre /ID# 221114

location_facility: Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 221150

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 233727

location_facility: Inselspital, Universitätsspital Bern /ID# 223439

location_facility: Nippon Medical School Hospital /ID# 221676

location_facility: Hospital Universitario Vall d'Hebron /ID# 240979

location_facility: Iwate Medical University Hospital /ID# 222044

location_facility: Hospital of the University of Pennsylvania /ID# 219001

location_facility: A.O.U. Citta della Salute e della Scienza di Torino /ID# 221223

location_facility: The Cancer Institute at St. Francis Hospital /ID# 231782

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 222696

location_facility: Universitaetsklinikum St. Poelten /ID# 221709

location_facility: Kansai Medical University Hospital /ID# 257289

location_facility: National Cancer Center Hospital East /ID# 226653

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 219127

location_facility: Tokyo Medical University Hospital /ID# 221540

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 221179

location_facility: Highlands Oncology Group, PA /ID# 221826

location_facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 219089

location_facility: Hospital Universitario Central de Asturias /ID# 224815

location_facility: Gachon University Gil Medical Center /ID# 220972

location_facility: Fejér Vármegyei Szent György Egyetemi Oktató Kórház /ID# 220949

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 231059

location_facility: United Lincolnshire Hospitals NHS Trust /ID# 224613

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 238438

location_facility: Hospital Universitario 12 de Octubre /ID# 233726

location_facility: The Lady Davis Carmel Medical Center /ID# 222973

location_facility: Kobe City Medical Center General Hospital /ID# 221156

location_facility: Utah Cancer Specialists Salt Lake Clinic /ID# 221962

location_facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 220946

location_facility: Shonan Kamakura General Hospital /ID# 223030

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 221222

location_facility: Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 221078

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 218980

location_facility: Augusta-Kranken-Anstalt gGmbH, Bochum-Mitte /ID# 224695

location_facility: James Paget University Hospitals NHS Foundation Trust /ID# 221219

location_facility: Columbus Regional Research Institute /ID# 224410

location_facility: Medizinische Universitaet Graz /ID# 220919

location_facility: Tula Regional Clinical Hospital /ID# 221302

location_facility: Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221115

location_facility: Juntendo University Hospital /ID# 221154

location_facility: Hadassah Medical Center-Hebrew University /ID# 219111

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 220947

location_facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 231649

location_facility: China Medical University Hospital /ID# 218979

location_facility: Hospital Universitario La Paz /ID# 224813

location_facility: Hospital Parc de Salut del Mar /ID# 220922

location_facility: Medizinische Universitaet Wien /ID# 220911

location_facility: Fujita Health University Hospital /ID# 221598

location_facility: Hospital Universitario Dr. Negrin /ID# 220923

location_facility: Hospital Regional Universitario de Malaga /ID# 221906

location_facility: Seoul National University Hospital /ID# 219060

location_facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 221220

location_facility: CHU NIMES - Hopital Caremeau /ID# 219128

location_facility: Niigata University Medical & Dental Hospital /ID# 223034

location_facility: General Hospital of Athens Laiko /ID# 221175

location_facility: McGill University Health Center Research Institute /ID# 222614

location_facility: Taipei Veterans General Hosp /ID# 221147

location_facility: Saint Louis University Cancer Center /ID# 222287

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 221334

location_facility: Juntendo University Shizuoka Hospital /ID# 221780

location_facility: Manhattan Hematology Oncology MHO Associates /ID# 223193

location_facility: Assaf Harofeh Medical Center /ID# 222972

location_facility: CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 222433

location_facility: General Hospital of Thessaloniki George Papanikolaou /ID# 221463

location_facility: MTZ Clinical Research Powered by Pratia /ID# 221759

location_facility: Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 225025

location_facility: Skane University Hospital Lund /ID# 220834

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im. M. Kopern /Id# 221161

location_facility: University of Miyazaki Hospital /ID# 221821

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 221526

location_facility: Summit Medical Group-Florham Park /ID# 222620

location_facility: University Clinical Center Serbia /ID# 231058

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 218985

location_facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 221081

location_facility: University General Hospital of Patras /ID# 221178

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221346

location_facility: Universitatsklinikum Mannheim /ID# 221529

location_facility: Hospital Clinico Universitario de Valencia /ID# 220920

location_facility: OncoResearch Lerchenfeld GmbH /ID# 225034

location_facility: The Institute of Medical Science the University of Tokyo Hospital /ID# 257944

location_facility: Sjællands Universitetshospital /ID# 224456

location_facility: University of Texas Health San Antonio MD Anderson Cancer Center /ID# 233942

location_facility: Universitaetsmedizin Rostock /ID# 224157

location_facility: Indiana Blood & Marrow Transpl /ID# 221587

location_facility: American Oncology Partners of Maryland, PA /ID# 222836

location_facility: Tokyo Metropolitan Bokutoh Hospital /ID# 254774

location_facility: Moores Cancer Center at UC San Diego /ID# 219009

location_facility: Klinicki bolnicki centar Zagreb /ID# 230798

location_facility: Hospital Universitario Virgen de las Nieves /ID# 253936

location_facility: Fukushima Medical University Hospital /ID# 221877

location_facility: Pusan National University Hospital /ID# 220980

title: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination With Ruxolitinib Versus Best Available Therapy in Subjects With Relapsed/Refractory Myelofibrosis (TRANSFORM-2)

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

location_country:
Germany
Poland
New Zealand
Australia
Japan
Turkey
Croatia
Czechia
Canada
Serbia
France
Hungary
Denmark
Switzerland
United States
Belgium
Puerto Rico
Italy
United Kingdom
Sweden
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


acronym: DIONE

lead_sponsor: Theravance Biopharma

summary: A Phase 2 study to evaluate the efficacy, safety and tolerability of TD-1473 in subjects with moderately-to-severely active Crohn's Disease with up to 48 weeks of treatment.

location_facility: Theravance Biopharma Investigational Site

title: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo˗Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy With 2 Doses of TD-1473 in Subjects With Moderately-to-Severely Active Crohn's Disease

ipd_sharing_description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

location_country:
Germany
Poland
New Zealand
Australia
Croatia
Serbia
France
Portugal
Hungary
United States
Ukraine
Romania
United Kingdom
Austria
Korea, Republic of
Spain
Greece
South Africa
Bulgaria
Georgia
Russian Federation
Israel


title: A Phase 3 Randomized, Controlled, Open-label Study of Selinexor, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

acronym: BOSTON

summary: This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study will compare the efficacy and health-related quality of life (HR-QoL) and assess the safety of selinexor plus bortezomib (Velcade) plus low-dose dexamethasone (SVd) versus bortezomib plus low-dose dexamethasone (Vd) in adult patients with RRMM who have received 1 to 3 prior anti-multiple myeloma (MM) regimens. Crossover from the Vd Arm to a treatment that includes selinexor (i.e., SVdX or SdX) will be allowed at the point of IRC-confirmed objective disease progression per the IMWG criteria for patients in the Vd Arm.

ReferenceCitation: Delimpasi S, Mateos MV, Auner HW, Gavriatopoulou M, Dimopoulos MA, Quach H, Pylypenko H, Hajek R, Leleu X, Dolai TK, Sinha DK, Venner CP, Benjamin R, Garg MK, Doronin V, Levy Y, Moreau P, Chai Y, Arazy M, Shah J, Shacham S, Kauffman MG, Richardson PG, Grosicki S. Efficacy and tolerability of once-weekly selinexor, bortezomib, and dexamethasone in comparison with standard twice-weekly bortezomib and dexamethasone in previously treated multiple myeloma with renal impairment: Subgroup analysis from the BOSTON study. Am J Hematol. 2022 Mar 1;97(3):E83-E86. doi: 10.1002/ajh.26434. Epub 2021 Dec 29. No abstract available.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_concat: University of Melbourne - Minerva Access

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

ReferenceCitation: Richard S, Chari A, Delimpasi S, Simonova M, Spicka I, Pour L, Kriachok I, Dimopoulos MA, Pylypenko H, Auner HW, Leleu X, Usenko G, Hajek R, Benjamin R, Dolai TK, Sinha DK, Venner CP, Garg M, Stevens DA, Quach H, Jagannath S, Moreau P, Levy M, Badros A, Anderson LD Jr, Bahlis NJ, Facon T, Mateos MV, Cavo M, Chang H, Landesman Y, Chai Y, Arazy M, Shah J, Shacham S, Kauffman MG, Grosicki S, Richardson PG. Selinexor, bortezomib, and dexamethasone versus bortezomib and dexamethasone in previously treated multiple myeloma: Outcomes by cytogenetic risk. Am J Hematol. 2021 Sep 1;96(9):1120-1130. doi: 10.1002/ajh.26261. Epub 2021 Jul 5.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

evidence: oa repository (via pmcid lookup)

unpaywall_oa_status: hybrid

ReferenceCitation: Mateos MV, Gavriatopoulou M, Facon T, Auner HW, Leleu X, Hajek R, Dimopoulos MA, Delimpasi S, Simonova M, Spicka I, Pour L, Kriachok I, Pylypenko H, Doronin V, Usenko G, Benjamin R, Dolai TK, Sinha DK, Venner CP, Garg M, Stevens DA, Quach H, Jagannath S, Moreau P, Levy M, Badros AZ, Anderson LD Jr, Bahlis NJ, Cavo M, Chai Y, Jeha J, Arazy M, Shah J, Shacham S, Kauffman MG, Richardson PG, Grosicki S. Effect of prior treatments on selinexor, bortezomib, and dexamethasone in previously treated multiple myeloma. J Hematol Oncol. 2021 Apr 13;14(1):59. doi: 10.1186/s13045-021-01071-9.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: University of Melbourne - Minerva Access

repository_institution: Imperial College London - Spiral

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;cris.unibo.it;spiral.imperial.ac.uk

repositories_institution: University of Melbourne - Minerva Access

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Auner HW, Gavriatopoulou M, Delimpasi S, Simonova M, Spicka I, Pour L, Dimopoulos MA, Kriachok I, Pylypenko H, Leleu X, Doronin V, Usenko G, Hajek R, Benjamin R, Dolai TK, Sinha DK, Venner CP, Garg M, Stevens DA, Quach H, Jagannath S, Moreau P, Levy M, Badros A, Anderson LD Jr, Bahlis NJ, Facon T, Mateos MV, Cavo M, Chai Y, Arazy M, Shah J, Shacham S, Kauffman MG, Richardson PG, Grosicki S. Effect of age and frailty on the efficacy and tolerability of once-weekly selinexor, bortezomib, and dexamethasone in previously treated multiple myeloma. Am J Hematol. 2021 Jun 1;96(6):708-718. doi: 10.1002/ajh.26172. Epub 2021 May 3.

repositories_concat: University of Melbourne - Minerva Access;cris.unibo.it

ReferenceCitation: Grosicki S, Simonova M, Spicka I, Pour L, Kriachok I, Gavriatopoulou M, Pylypenko H, Auner HW, Leleu X, Doronin V, Usenko G, Bahlis NJ, Hajek R, Benjamin R, Dolai TK, Sinha DK, Venner CP, Garg M, Gironella M, Jurczyszyn A, Robak P, Galli M, Wallington-Beddoe C, Radinoff A, Salogub G, Stevens DA, Basu S, Liberati AM, Quach H, Goranova-Marinova VS, Bila J, Katodritou E, Oliynyk H, Korenkova S, Kumar J, Jagannath S, Moreau P, Levy M, White D, Gatt ME, Facon T, Mateos MV, Cavo M, Reece D, Anderson LD Jr, Saint-Martin JR, Jeha J, Joshi AA, Chai Y, Li L, Peddagali V, Arazy M, Shah J, Shacham S, Kauffman MG, Dimopoulos MA, Richardson PG, Delimpasi S. Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial. Lancet. 2020 Nov 14;396(10262):1563-1573. doi: 10.1016/S0140-6736(20)32292-3.

repository_institution: University of Wolverhampton - Wolverhampton Intellectual Repository and E-Theses

location_country:
Germany
Poland
Australia
Czechia
Canada
Serbia
France
Hungary
United States
Ukraine
India
Romania
Belgium
Italy
United Kingdom
Austria
Spain
Greece
Bulgaria
Russian Federation
Israel

location_facility: Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)

location_facility: University Hospital Kralovske Vinohrady, Clinic of Internal Hematology

location_facility: Theageneion Cancer Hospital, Hematology Department

location_facility: Hospital Center Departmental La Roche-Sur-Yon

location_facility: Catalan Institute of Oncology (ICO) Badalona

location_facility: University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital

location_facility: University Hospital Careggi, Department of Hematology

location_facility: Independent Public Healthcare Facility Municipal Hospital Group in Chorzow, Department of Hematology

location_facility: University Hospital Ostrava, Dept. of Hematooncology

location_facility: Integrated Szent Istvan and Szent laszlo Hospital, Department of Hematology and Stem Cell Transplantation

location_facility: Necker Children's Hospital, Department of Adult Hematology

location_facility: Medical Center of the University of Pecs, Department of Hematology

location_facility: Mater Misericordiae Limited and Mater Medical Research

location_facility: University Hospitals of Leicester NHS Trust Royal Leicester Infirmary

location_facility: University Hospital Infanta Leonor, Department of Hematology

location_facility: General Hospital of Athens "Evangelismos", Department of Hematology and Lymphoma

location_facility: Imperial College Healthcare NHS Trust Hammersmith Hospital

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Institute of Blood Pathology and Transfusion Medicine, Department of Hematology with Laboratory Group

location_facility: Clinical Center Nis, Clinic of Hematology and Clinical Immunology

location_facility: Specialized Hospital for Active Treatment of Hematological Diseases, Clinic of Hematology, Dept. of Clinical Hematology

location_facility: Boca Raton Clinical Research (BRCR) Medical Center

location_facility: Clinical Center of Vojvodina, Clinic of Hematology

location_facility: University Hospital in Krakow, Teaching Unit of the Hematology Department

location_facility: University Hospital Virgen del Rocio (HUVR)

location_facility: Semmelweis University, 1st Department of Internal Medicine

location_facility: St. John of Dukla Oncology Center of Lublin, Department of Hematology

location_facility: Tom Baker Cancer Center/ Alberta Health Services

location_facility: Bucharest University Emergency Hospital, Department of Hematology

location_facility: Vinnytsia M.I. Pyrohov Regional Clinical Hospital, Department of Hematology

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti

location_facility: Saskatchewan Cancer Agency-Allan Blair Cancer Centre

location_facility: Colentina Clinical Hospital, Department of Hematology

location_facility: Independent Public Teaching Hospital No.1 in Lublin, Department of Hematology-Oncology and Bone Marrow Transplantation

location_facility: Clinical Center of Serbia, Clinic of Hematology

location_facility: Polyclinic S. Orsola-Malpighi, Department of Hematology, Oncology and Laboratory Medicine, Operative Unit of Hematology - Cavo

location_facility: The Leeds Teaching Hospitals NHS Trust St. James University Hospital

location_facility: Hospital Niguerda Ca Granda, Department of Hematology and Oncology, Hematology Unit

location_facility: University Hospital Krems, Department of Internal Medicine II

location_facility: University Hospital San Martino, IRCCA, Dept. of Integrative Cancer Therapies, Operative Unit of Clinical Hematology

location_facility: The Cancer Institute at St. Francis Hospital

location_facility: Jan Biziel University Hospital #2 in Bydgoszcz, Department of Hematology

location_facility: Brabois Adults Hospital, University Hospital Center of Nancy

location_facility: First I.P. Pavlov State Medical University of St. Petersburg

location_facility: Postgraduate Institute of Medical Education & Research (PGIMER)

location_facility: Cardiff & Vale University Health Board University Hospital of Wales

location_facility: O.F. Herbachevskyi Regional Clinical Hospital, Hematology Department with Intensive Therapy Wards

location_facility: Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center, Department of Hematology

location_facility: Kaposi Mor Teaching Hospital, 2nd Department of Internal Medicine

location_facility: V.A. Almazov North-West Federal Medical Research Center, Chemotherapy of Oncohematology Diseases and Bone Marrow Transplantation Department #1

location_facility: N.A. Semashko Central Clinical Hospital #2 under OJSC Russian Railways

location_facility: University Hospital San Giovanni Battista of Turin

location_facility: Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Hematology

location_facility: Klinikum Leverkusen gGmbH Medizinisxhe Klinik 3

location_facility: Hyperclnical MedLife PDR Vulturului Brasov, Hematology Department

location_facility: University Clinical Hospital of Salamanca, Department of Hematology

location_facility: London North West Healthcare NHS Trust Northwick Park Hospital

location_facility: The Royal Wolverhampton NHS Trust New Cross Hospital

location_facility: University Multiprofile Hospital for Active Treatment, Sveti Georgi Clinic of Clinical Hematology

location_facility: Royal Liverpool & Broadgreen University Hospital NHS Trust Royal Liverpool University Hospital

location_facility: University Hospital of the Canary Islands

location_facility: Belfast Heatlh & Social Care Trust Belfast City Hospital

location_facility: University Hospital Freiburg, Department of Internal Medicine I

location_facility: Group Practice for Hematology and Oncology

location_facility: Institute of Oncology and Radiology of Serbia, Clinic of Medical Oncology

location_facility: Netaji Subhash Chandra Bose Cancer Research Institute

location_facility: University Multiprofile Hospital for Active Treatment, Sveti Ivan Rilski Clinic of Hematology

location_facility: Clinical Center Kragujevac, Clinic of Hematology

location_facility: Miletrie Hospital, University Hospital Center of Poitiers

location_facility: Alexandra General Hospital, Therapeutic Clinic

location_facility: Umberto I Polyclinic of Rome, Department of Cellular Biotechnology and Hematology, Hematology Center

location_facility: Royal Victoria Hospital / McGill University

location_facility: Stormont Vail Health Care (Cotton O'Neil Cancer Center )

location_facility: City Clinical Hospital No.4 of Dnipro City Council, City hematology center

location_facility: Military Institute of Medicine, Department of Internal Medicine and Hematology

location_facility: Cross Cancer Institute / University of Alberta

location_facility: Wilhelminen Hospital, Department of Internal Medicine I, Center for Oncology & Hematology

location_facility: Semmelweis University, 3rd Department of Internal Medicine


title: A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

summary: The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer.

status: Completed

ReferenceType: background

ReferenceCitation: Han HS, Dieras V, Robson M, Palacova M, Marcom PK, Jager A, Bondarenko I, Citrin D, Campone M, Telli ML, Domchek SM, Friedlander M, Kaufman B, Garber JE, Shparyk Y, Chmielowska E, Jakobsen EH, Kaklamani V, Gradishar W, Ratajczak CK, Nickner C, Qin Q, Qian J, Shepherd SP, Isakoff SJ, Puhalla S. Veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in patients with BRCA1/2 locally recurrent/metastatic breast cancer: randomized phase II study. Ann Oncol. 2018 Jan 1;29(1):154-161. doi: 10.1093/annonc/mdx505.

ReferenceCitation: Isakoff SJ, Puhalla S, Domchek SM, Friedlander M, Kaufman B, Robson M, Telli ML, Dieras V, Han HS, Garber JE, Johnson EF, Maag D, Qin Q, Giranda VL, Shepherd SP. A randomized Phase II study of veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in BRCA1/2 metastatic breast cancer: design and rationale. Future Oncol. 2017 Feb;13(4):307-320. doi: 10.2217/fon-2016-0412. Epub 2016 Oct 14.

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Future Science Ltd

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

location_country:
Finland
Poland
Argentina
Australia
Brazil
Czechia
Canada
France
Hungary
Denmark
United States
Ukraine
Romania
Belgium
Norway
Sweden
Netherlands
Spain
Russian Federation
Israel

location_facility: Stanford University School of Med /ID# 65488

location_facility: Rush University Medical Center /ID# 65489

location_facility: Institut de Cancer de l'Ouest /ID# 63927

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 65178

location_facility: Wielkopolskie Centrum Onkologi /ID# 71061

location_facility: Soroka University Medical Center /ID# 65180

location_facility: Moore UC San Diego Cancer Center /ID# 60754

location_facility: Hospital Universitario HM Sanchinarro /ID# 97416

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 63940

location_facility: University of Alabama at Birmingham - Main /ID# 62994

location_facility: Massachusetts General Hospital /ID# 64582

location_facility: Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 97697

location_facility: University of Arkansas for Medical Sciences /ID# 60750

location_facility: UT Southwestern Medical Center /ID# 60745

location_facility: Hospital Clinico Universitario de Valencia /ID# 97975

location_facility: Gastroenterology Institute, Division of Medicine /ID# 63931

location_facility: Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 63941

location_facility: Hospital General Universitario Gregorio Maranon /ID# 97417

location_facility: Duke University Medical Center /ID# 60747

location_facility: Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 65280

location_facility: Houston Methodist Hospital - Scurlock Tower /ID# 60742

location_facility: Pays-Basque Ctr Oncology/Radio /ID# 65176

location_facility: Hospital Universitario Virgen de la Victoria /ID# 97976

location_facility: Hospital de Clinicas de Porto Alegre /ID# 65242

location_facility: Hospital Santa Creu i Sant Pau /ID# 97418

location_facility: Cliniques Universitaires Saint Luc /ID# 96135

location_facility: Centrum Onkologii Lukaszczyka /ID# 73393

location_facility: Medical University of South Carolina /ID# 60752

location_facility: Florida Cancer Specialists - East /ID# 60762

location_facility: Sunnybrook Health Sciences Ctr /ID# 77373

location_facility: Banner MD Anderson Cancer Ctr /ID# 118695

location_facility: lnstitutul Oncologic Trestiore /ID# 96742

location_facility: Haukeland University Hospital /ID# 67982

location_facility: Communal non-profit enterprise Regional Center of Oncology /ID# 97696

location_facility: N.N. Petrov Research Inst Onc /ID# 65269

location_facility: Rigshospitalet, Finsen Centre /ID# 67822

location_facility: State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 102415

location_facility: The Angeles Clinic and Researc /ID# 60743

location_facility: Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 65263

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 63928

location_facility: Hospital Universitario Vall d'Hebron /ID# 97415

location_facility: Pyatigorsk Oncology Dispensary /ID# 65264

location_facility: Spitalul Clinic Judetean de Urgenta /ID# 96741

location_facility: Penn State University and Milton S. Hershey Medical Center /ID# 62723

location_facility: Northwestern University Feinberg School of Medicine /ID# 60755

location_facility: Washington University-School of Medicine /ID# 62724

location_facility: Univ of Colorado Cancer Center /ID# 60751

location_facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 63222

location_facility: Southern Medical Day Care Ctr /ID# 63274

location_facility: Cedars-Sinai Medical Center - West Hollywood /ID# 60760

location_facility: Inst Oncology Prof. Chiricuta /ID# 96740

location_facility: Chelyabinsk Reg Clin Oncology /ID# 63938

location_facility: Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 94975

location_facility: Hospital Bruno Born / Sociedade Beneficencia e Caridade de Lajeado /ID# 65247

location_facility: AZ St-Jan Brugge-Oostende AV /ID# 107315

location_facility: University of Illinois - Chicago /ID# 106175

location_facility: N.N. Petrov Research Inst Onc /ID# 78973

status_simplified: Completed


title: A Randomized, Double-blind Phase 2 Study Comparing Gemcitabine and Cisplatin in Combination With OGX-427 or Placebo in Patients With Advanced Transitional Cell Carcinoma

summary: The primary objective of this study is to ascertain whether there is evidence of longer survival relative to the control arm for three comparisons: 600 mg OGX-427 Arm to control Arm; 1000 mg OGX-427 Arm to control Arm; and pooled 600 mg and 1000 mg OGX-427 Arms to control Arm.

lead_sponsor: Achieve Life Sciences

sponsor_collaborators:
Achieve Life Sciences
PRA Health Sciences

location_country:
Germany
Italy
Poland
United States
Spain
Canada
France

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: Urology Cancer Center and GU Research Network

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: Montefiore Medical Center, Albert Einstein College of Medicine

location_facility: Centre Hospitalier Universitaire, Institut Gustave Roussy

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

location_facility: Fondazione IRCCS Policlinico San Matteo Pavia

location_facility: Centre Hospitalier Régional et Universitaire - Hôpital

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

location_facility: Akademicki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Instituto Valenciano de Oncología-Fundación (IVO-FINCIVO)

location_facility: Klinikum Rechts der Isar der Technischen Universität

location_facility: Siteman Cancer Center, Washington University School of Medicine

location_facility: R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health

location_facility: Institut Català D'Oncologia, Hospital Duran i Reynals


title: An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Multiple Solid Tumors

summary: The purpose of this study is to determine the safety and efficacy of belzutifan in combination with pembrolizumab and lenvatinib in multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC), endometrial cancer (EC),and esophageal squamous cell carcinoma (ESCC). There is no formal hypothesis testing in this study.

location_country:
New Zealand
Israel
Australia
Netherlands
Belgium
United States
Korea, Republic of
Spain
Chile
France

location_facility: Rambam Health Care Campus-Oncology ( Site 1300)

location_facility: Samsung Medical Center-Division of Hematology/Oncology ( Site 4102)

location_facility: City of Hope Comprehensive Cancer Center ( Site 5002)

location_facility: Hospital Universitari Vall d'Hebron-Oncology ( Site 1800)

location_facility: University of Florida College of Medicine ( Site 5015)

location_facility: Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan ( Site 1107)

location_facility: Hôpital Beaujon-Oncologie Digestive ( Site 1104)

location_facility: Chonnam National University Hwasun Hospital-Hemato-Oncology ( Site 4105)

location_facility: Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 1003)

location_facility: Sainte Catherine Institut du Cancer Avignon Provence ( Site 1108)

location_facility: Sourasky Medical Center-Oncology ( Site 1301)

location_facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 4100)

location_facility: CHU Besançon-Medical oncology ( Site 1101)

location_facility: Westmead Hospital-Department of Medical Oncology ( Site 4001)

location_facility: Maastricht UMC+-Medical Oncology ( Site 1501)

location_facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1801)

location_facility: Inova Schar Cancer Institute ( Site 5039)

location_facility: University of Texas MD Anderson Cancer Center-Gastrointestinal Medical Oncology ( Site 5049)

location_facility: University of Wisconsin Hospitals and Clinics ( Site 5037)

location_facility: University of Arizona Cancer Center-University of Arizona Cancer Center - North Campus ( Site 5047)

location_facility: CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 1807)

location_facility: Centro Investigación del Cáncer James Lind ( Site 3107)

location_facility: Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1001)

location_facility: Hospital Universitario Central de Asturias-Medical Oncology ( Site 1802)

location_facility: Northwest Medical Specialties, PLLC ( Site 5025)

location_facility: Gosford Hospital-Oncology Trials ( Site 4004)

location_facility: UCSF Medical Center at Mission Bay ( Site 5021)

location_facility: Centre Hospitalier Universitaire de Grenoble-Medical Oncology ( Site 1105)

location_facility: Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1503)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 5050)

location_facility: Auckland City Hospital-Liver Research Unit ( Site 4201)

location_facility: Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 1806)

location_facility: Seoul National University Hospital-Internal Medicine ( Site 4103)

location_facility: Hadassah Medical Center-Oncology ( Site 1303)

location_facility: Cedars-Sinai Medical Center ( Site 5045)

location_facility: Keimyung University Dongsan Hospital ( Site 4104)

location_facility: Northern Hospital-Department of Medical Oncology ( Site 4003)

location_facility: Leids Universitair Medisch Centrum-Medical Oncology ( Site 1504)

location_facility: Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1103)

location_facility: Institut Régional du Cancer Montpellier ( Site 1106)

location_facility: Cabrini Hospital - Malvern-Cabrini Institute ( Site 4000)

location_facility: Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - GI and Immunology ( Site 5048)

location_facility: Antwerp University Hospital-Oncology ( Site 1002)

location_facility: Asan Medical Center-Department of Oncology ( Site 4101)

location_facility: Yale-New Haven Hospital-Yale Cancer Center ( Site 5013)

location_facility: Sheba Medical Center-ONCOLOGY ( Site 1302)

location_facility: Auckland City Hospital-Cancer & Blood Research ( Site 4200)


summary:
Hepatitis C Virus (HCV) infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection.

GLE/PIB is an approved drug for the treatment of chronic HCV. Around 283 participants at least 12 years of age with acute HCV Infection will be enrolled in approximately 70 sites worldwide.

Participants will receive oral tablets of GLE/PIB once daily (QD) for 8 weeks and will be followed for 12 weeks after the end of treatment.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, monitoring for side effects and completing questionnaires.

location_facility: zibp-Zentrum fuer Infektiologie /ID# 226765

location_facility: Midway Immunology and Research Center /ID# 229194

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 226698

location_facility: Hospital Parc de Salut del Mar /ID# 226696

location_facility: ICH Study Center GmbH & Co KG /ID# 228162

location_facility: Weill Cornell Medical College /ID# 230815

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 227183

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 227126

location_facility: University of California, Davis Comprehensive Cancer Center /ID# 230814

location_facility: AP-HP - Hopital Saint-Antoine /ID# 229070

location_facility: AHF Healthcare Center- Hollywood /ID# 254794

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 227078

location_facility: Medical College of Wisconsin - Plank Rd /ID# 230116

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 227079

location_facility: Emory Midtown Infectious Disease Clinic /ID# 229927

location_facility: The Institute for Liver Health /ID# 228427

location_facility: Vancouver Infectious Diseases Centre /ID# 227125

location_facility: Angels Clinical Research Institute /ID# 234090

location_facility: Hospital Universitario Infanta Leonor /ID# 251780

location_facility: Coastal Research Institute, LLC /ID# 233233

location_facility: Vanderbilt University Medical Center /ID# 241282

location_facility: North Jersey Community Research Initiative (NJCRI) /ID# 245129

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 226783

location_facility: Digestive and Liver Disease Sp /ID# 232633

location_facility: Hospital General Universitario de Valencia /ID# 226709

location_facility: Azienda Ospedaliera Universitaria Ospedali Riuniti /ID# 227081

location_facility: Hospital Clinic de Barcelona /ID# 226695

location_facility: AIDS Healthcare Foundation - Northpoint /ID# 254814

location_facility: University of Louisville Research Foundation Inc /ID# 232139

location_facility: Universitaetsklinikum St. Poelten /ID# 227098

location_facility: University of Mississippi Medical Center /ID# 232620

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 227080

location_facility: Velocity Clinical Research Chula Vista /ID# 238352

location_facility: Medizinische Universitaet Wien /ID# 226938

location_facility: HCL - Hopital de la Croix-Rousse /ID# 259102

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 226985

location_facility: University of Kentucky Chandler Medical Center /ID# 231588

location_facility: Cherokee Nation Outpatient Health Center /ID# 232618

location_facility: HCL - Hopital de la Croix-Rousse /ID# 229077

location_facility: University of Iowa Hospitals and Clinics /ID# 226934

location_facility: Liver Associates of Texas, P.A /ID# 229775

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 229083

title: A Multicenter, Single-Arm Prospective Study to Evaluate Safety and Efficacy of GLE/PIB 8-Week Treatment in Adults and Adolescents With Acute Hepatitis C Virus (HCV) Infection

location_country:
Germany
Italy
Australia
Austria
United States
Spain
Canada
France