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).

lead_sponsor: Merck Sharp & Dohme LLC

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

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

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

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

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

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

location_facility: Faculty of Medicine Siriraj Hospital ( Site 3002)

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

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

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

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

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

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

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

location_facility: Englewood Hospital and Medical Center ( Site 3557)

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

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

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

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

location_facility: Okayama University Hospital ( Site 1720)

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

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

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

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

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

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

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

location_facility: Centro de Oncología Personalizada ( Site 1911)

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

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

location_facility: National Taiwan University Hospital ( Site 2904)

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

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

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

location_facility: Ankara University Hospital Cebeci ( Site 3209)

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

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

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

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

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

location_facility: Hospital Lucus Augusti-Oncology ( Site 2706)

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

location_facility: Sourasky Medical Center-Oncology ( Site 1501)

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

location_facility: Helios Klinikum Berlin-Buch ( Site 1011)

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

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

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

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

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

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

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

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

location_facility: Toho University Sakura Medical Center ( Site 1718)

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

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

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

location_facility: Kaohsiung Veterans General Hospital ( Site 2901)

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

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

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

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

location_facility: Sheba Medical Center-ONCOLOGY ( Site 1504)

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

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

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

location_facility: National Cancer Center Hospital East ( Site 1704)

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

location_facility: Taipei Veterans General Hospital ( Site 2903)

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

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

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

location_facility: Centro de Investigación Oncológica del Norte ( Site 0303)

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

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

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

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

location_facility: University Malaya Medical Centre ( Site 1804)

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

location_facility: Chongqing University Cancer Hospital ( Site 0414)

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

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

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

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

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

location_facility: Taichung Veterans General Hospital ( Site 2902)

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

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

location_facility: Hokkaido University Hospital ( Site 1701)

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

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

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

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

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

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

location_facility: Asan Medical Center-Oncology ( Site 2601)

location_facility: Christus Muguerza Clinica Vidriera ( Site 1903)

location_facility: McGill University Health Centre ( Site 3709)

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

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

location_facility: Tallaght University Hospital ( Site 1402)

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

location_facility: Hacettepe Universitesi-oncology hospital ( Site 3203)

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

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

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

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

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

location_facility: Chinese PLA General Hospital ( Site 0415)

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

location_facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1101)

location_facility: Sapporo Medical University Hospital ( Site 1702)

location_facility: Tri-Service General Hospital ( Site 2908)

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

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

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

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

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

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

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

location_facility: Inova Schar Cancer Institute ( Site 3525)

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

location_facility: Universitaetsklinikum Essen ( Site 1004)

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

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

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

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

location_facility: Tampereen yliopistollinen sairaala ( Site 0805)

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

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

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

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

location_facility: Kagoshima University Hospital ( Site 1719)

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

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

location_facility: Nara Medical University Hospital ( Site 1712)

location_facility: Oulun yliopistollinen sairaala ( Site 0802)

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

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

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

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

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

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

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

location_facility: UT Southwestern Medical Center ( Site 3529)

location_facility: Nippon Medical School Hospital ( Site 1705)

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

location_facility: Fundación Instituto Valenciano de Oncología ( Site 2705)

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

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

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

location_facility: Universitaetsklinikum Duesseldorf ( Site 1017)

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

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

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

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

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

location_facility: Georgetown University Medical Center ( Site 3534)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 3568)

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

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

location_facility: Hamamatsu University Hospital ( Site 1708)

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

location_facility: Tergooiziekenhuizen, locatie Hilversum ( Site 3102)

location_facility: Ningbo First Hospital-Urology ( Site 0433)

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

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

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

location_facility: Universitaetsklinikum Tuebingen ( Site 1002)

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

location_facility: CHU Besançon-Medical oncology ( Site 0904)

location_facility: The Christie NHS Foundation Trust ( Site 3301)

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

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

location_facility: Wakayama Medical University Hospital ( Site 1721)

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

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

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

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

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

location_facility: Rabin Medical Center-Oncology ( Site 1503)

location_facility: Hospital Universitari de Girona Doctor Josep Trueta ( Site 2707)

location_facility: National Cancer Centre Singapore ( Site 3601)

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

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

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


type: Other Identifier

type: Registry Identifier

type: EudraCT Number

title: A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)

summary: The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The dual primary hypotheses are preoperative EV + pembrolizumab and RC + PLND (Arm A) will achieve superior pathologic complete response (pCR) rate and perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).

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

location_country:
Spain
Italy
Ukraine
United States
Romania
Japan
South Africa
Czechia
Poland
Portugal
Russian Federation
Australia
Israel
Malaysia
Singapore
Canada
China
Germany
Bulgaria
Taiwan
Greece
Korea, Republic of
France

location_facility: Saint Francis Cancer Center ( Site 0008)

location_facility: Fudan University Shanghai Cancer Center-Urology department ( Site 1401)

location_facility: Clinical Research Center Medic-R ( Site 1061)

location_facility: Centre Hospitalier Regional du Orleans ( Site 0463)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 0598)

location_facility: CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 0660)

location_facility: The University of Tennessee Medical Center ( Site 0034)

location_facility: MHAT Central Onco Hospital OOD ( Site 1158)

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

location_facility: National Medical Research Radiology Centre ( Site 0869)

location_facility: MNPE Regional Center of Oncology ( Site 0955)

location_facility: Rabin Medical Center-Oncology ( Site 0752)

location_facility: Volga District Medical Center ( Site 0876)

location_facility: Hospital Universitario Central de Asturias ( Site 0654)

location_facility: Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0254)

location_facility: Frankston Hospital-Oncology and Haematology ( Site 1258)

location_facility: Sourasky Medical Center-Oncology ( Site 0755)

location_facility: Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0409)

location_facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0301)

location_facility: Chonnam National University Hwasun Hospital ( Site 1353)

location_facility: University General Hospital of Larissa ( Site 0302)

location_facility: Altay Regional Oncology Dispensary ( Site 0851)

location_facility: Duke University Medical Center ( Site 0017)

location_facility: Universitaetsklinikum Freiburg ( Site 0512)

location_facility: Rambam Health Care Campus-Oncology ( Site 0751)

location_facility: Sheba Medical Center-ONCOLOGY ( Site 0753)

location_facility: University of Tsukuba Hospital ( Site 1502)

location_facility: Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0965)

location_facility: Lviv Oncology Regional Treatment and Diagnostic Center ( Site 0960)

location_facility: Hospital Clinico Universitario San Carlos de Madrid ( Site 0651)

location_facility: Narodowy Instytut Onkologii ( Site 1051)

location_facility: University of California San Francisco ( Site 0010)

location_facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1406)

location_facility: Ospedali Riuniti Umberto I GM Lancis G Salesi ( Site 0593)

location_facility: University Malaya Medical Centre ( Site 0352)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 0461)

location_facility: Fundación Instituto Valenciano de Oncología-Oncologico ( Site 0662)

location_facility: Presidio Ospedaliero Santa Maria delle Grazie ( Site 0599)

location_facility: Meir Medical Center-oncology ( Site 0754)

location_facility: University of Louisville, James Graham Brown Cancer Center ( Site 0022)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 0657)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1053)

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole ( Site 0455)

location_facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0658)

location_facility: Kyungpook National University Chilgok Hospital ( Site 1354)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1055)

location_facility: Yitzhak Shamir Medical Center-Oncology ( Site 0756)

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1413)

location_facility: AOU San Luigi Gonzaga di Orbassano ( Site 0595)

location_facility: UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0305)

location_facility: St.Petersburg Clinical Hospital RAS ( Site 0864)

location_facility: Sverdlovsky Regional Clinical hospital #1 ( Site 0868)

location_facility: Kath. Krankenhaus Marienhospital. Universitaetsklinik ( Site 0511)

location_facility: Houston Methodist Urology Associates ( Site 0033)

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

location_facility: Universitaetsklinikum Muenster ( Site 0516)

location_facility: CHLO, EPE - Hospital de Sao Francisco Xavier ( Site 0401)

location_facility: CHU Limoges Hopital Dupuytren ( Site 0459)

location_facility: Hospital Universitari de Girona Doctor Josep Trueta ( Site 0653)

location_facility: Okayama University Hospital ( Site 1516)

location_facility: University of Wisconsin Hospital and Clinics ( Site 0037)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0852)

location_facility: SC Radiotherapy Center Cluj SRL ( Site 1108)

location_facility: Seoul National University Hospital ( Site 1351)

location_facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0661)

location_facility: BC Cancer - Vancouver Center ( Site 0110)

location_facility: Hamamatsu University Hospital ( Site 1511)

location_facility: Fakultni nemocnice u sv. Anny v Brne ( Site 0253)

location_facility: Hospital Geral de Santo Antonio ( Site 0408)

location_facility: Hirosaki University Hospital ( Site 1501)

location_facility: Zhytomyr Regional Oncology Center ( Site 0961)

location_facility: Kanazawa University Hospital ( Site 1509)

location_facility: Hadassah Medical Center-Oncology ( Site 0757)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1103)

location_facility: Xarxa Assistencial Universitaria Manresa ( Site 0655)

location_facility: St Joseph Heritage Healthcare-Oncology ( Site 0035)

location_facility: Oregon Health and Science University ( Site 0028)

location_facility: Hopital Diaconesses Croix Saint Simon ( Site 0465)

location_facility: Universitaetsklinik fuer Urologie ( Site 0501)

location_facility: Steve Biko Academic Hospital ( Site 0601)

location_facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1057)

location_facility: Tokyo Medical and Dental University Hospital ( Site 1505)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1107)

location_facility: Gachon University Gil Medical Center ( Site 1356)

location_facility: Fakultni Thomayerova nemocnice ( Site 0252)

location_facility: Seoul National University Bundang Hospital ( Site 1355)

location_facility: Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 0600)

location_facility: Complex Oncology Center Plovdiv ( Site 1151)

location_facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval ( Site 0952)

location_facility: Caritas Krankenhaus St. Josef ( Site 0502)

location_facility: Taipei Veterans General Hospital ( Site 1201)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1102)

location_facility: Nagasaki University Hospital ( Site 1517)

location_facility: Yokohama City University Medical Center ( Site 1508)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 0871)

location_facility: Mayo Clinic in Arizona - Phoenix ( Site 0043)

location_facility: St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0856)

location_facility: Sverdlovsk Regional Oncology Hospital ( Site 0867)

location_facility: University of Colorado, Anschutz Cancer Pavilion ( Site 0009)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 0509)

location_facility: MI Clinical oncology dispensary of Dnipropetrovsk regional council ( Site 0954)

location_facility: China Medical University Hospital ( Site 1202)

location_facility: University of Iowa Hospital and Clinics ( Site 0029)

location_facility: Centro Hospitalar e Universitario de Coimbra ( Site 0406)

location_facility: Krankenhaus Martha Maria Halle-Doelau ( Site 0507)

location_facility: Ottawa Hospital Research Institute ( Site 0109)

location_facility: National Medical Research Centre of Oncology named after N.N. Blokhin ( Site 0865)

location_facility: Nantong Tumor Hospital-Urology ( Site 1405)

location_facility: I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital ( Site 0959)

location_facility: Indiana University Melvin and Bren Simon Cancer Center ( Site 0050)

location_facility: Volgograd Regional Uronephrological Center ( Site 0870)

location_facility: Osaka International Cancer Institute ( Site 1514)

location_facility: General Hospital of Athens "Alexandra" ( Site 0303)

location_facility: Osaka Metropolitan University Hospital ( Site 1515)

location_facility: UT Southwestern Medical Center ( Site 0003)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0011)

location_facility: IRCCS Ospedale San Raffaele ( Site 0596)

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Ongoing


status: Active, not recruiting

primary_purpose: Other

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

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

lead_sponsor: Takeda

source: euctr

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.

enrollment_type: Actual

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

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Penn State Hershey Medical Center - Surgery

location_facility: AOU Policlinico di Modena - Gastroenterologia

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

location_facility: Istituto Clinico Humanitas Rozzano, IRCCS - IBD Center

location_facility: Morristown Medical Center - Gastroenterology

location_facility: University of Massachusetts - colon & rectal surgery

location_facility: Johns Hopkins Medicine - The Johns Hopkins Hospital

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: University Surgical Associates-Rhode Island Hospital

location_facility: North Shore University Hospital - Gastroenterology

location_facility: Dartmouth Hitchcock Medical Center - Cancer Center

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

location_facility: Hopital Saint Louis - Gastro-hepatoenterologie

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

location_facility: Shaare Zedek Medical Center - Gastroenterology

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Barnes-Jewish Hospital - Gastroenterology

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

location_facility: University of Kansas Sxchool of Medicine

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

location_facility: MH Egeszsegugyi Kozpont - Gasztroenterologiai Osztaly

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

location_facility: Virginia Mason Medical Center - Gastroenterology

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

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

location_facility: USF Health South Tampa Center for Advanced Healthcare

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.


status: Terminated

intervention_type: Drug

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.

study_completion_date_type: Actual

lead_sponsor: Institut de Recherches Internationales Servier

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.

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

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

location_facility: Magyar Református Egyház Bethesda Gyermekkórháza

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

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

location_facility: NAVICULA Centrum Diagnozy i Terapii Autyzmu w Łodzi

location_facility: Clínica Neurológica e Neurocirúrgica de Joinville

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

location_facility: Hospital General Universitario de Alicante

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

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

location_facility: Centre Hospitalier Charles Perrens CRA Aquitaine

location_facility: Institute of Neuropsychiatric Care, Department of Child Psychiatry

location_facility: University hospital of Ostrava, Department of Psychiatry

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

location_facility: Bekes Megyei Kozponti Korhaz Gyermek es ifjusagpszichiatriai osztaly

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

location_facility: Hospital Universitário Walter Cantídio-Universidade Federal do Ceará

location_facility: Centro Hospitalar e Universitario de Coimbra Hospital Pediatrico

location_facility: The Winnicott Centre 195-197 Hathersage Road

location_facility: University Hospital Brno, Department of Child Neurology

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

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

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

location_facility: Trial Tech em Pesquisas com Medicamentos Ltda

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

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

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

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

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.

status_simplified: Unknown


status: Enrolling by invitation

title: A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis

lead_sponsor: AbbVie

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols 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:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Portugal
Slovenia
Austria
Russian Federation
Argentina
Puerto Rico
Israel
Turkey
Mexico
Malaysia
Singapore
Sweden
Slovakia
Egypt
Brazil
Canada
Switzerland
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Latvia
New Zealand
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 165576

location_facility: Wellington Regional Hospital /ID# 205338

location_facility: The First Hospital of Jilin University /ID# 212277

location_facility: Shengjing Hospital of China Medical University /ID# 211643

location_facility: Inje University Haeundae Hospital /ID# 203027

location_facility: Policlinico Universitario Campus Bio-Medico /ID# 163994

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 165327

location_facility: Second Multiprofile Hospital f /ID# 200794

location_facility: Omega Research Maitland, LLC /ID# 203105

location_facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 161364

location_facility: Houma Digestive Health Special /ID# 158377

location_facility: Tsujinaka Hospital Kashiwanoha /ID# 225968

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171290

location_facility: Plains Clinical Research Center, LLC /ID# 169729

location_facility: Kaiser Clinica e Hospital Dia /ID# 157686

location_facility: Centro Hosp de Tondela-Viseu /ID# 166049

location_facility: Manhattan Clinical Research, LLC /ID# 211803

location_facility: Japanese Red Cross Wakayama Medical Center /ID# 171196

location_facility: Vanderbilt University Medical Center /ID# 160567

location_facility: Baylor Scott & White Center for Diagnostic Medicine /ID# 204132

location_facility: Klinicki bolnicki centar Zagreb /ID# 157594

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159473

location_facility: Cleveland Clinic Main Campus /ID# 209235

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 164348

location_facility: ProMedica Physicians Digestive Healthcare /ID# 215622

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 202060

location_facility: Caprock Gastro Research, LLC /ID# 215433

location_facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 205093

location_facility: Massachusetts General Hospital - Crohn's and Colitis Center /ID# 164257

location_facility: Bispebjerg and Frederiksberg Hospital /ID# 208953

location_facility: Digestive Disease Specialists /ID# 170777

location_facility: The Second Hospital of Hebei Medical University /ID# 213019

location_facility: CHU UCL Namur - site Godinne /ID# 200259

location_facility: Inselspital, Universitätsspital Bern /ID# 202909

location_facility: Servicio de Salud Araucanía Norte Hospital Victoria /ID# 213152

location_facility: WIP Warsaw IBD Point Profesor Kierkus /ID# 216103

location_facility: CNE Regional Clinical Hospital of Ivano-Frankivsk RC /ID# 203366

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 200686

location_facility: Sapporo Medical University Hospital /ID# 164278

location_facility: Centex Studies, Inc. - Houston /ID# 201221

location_facility: Hospital de Clinicas de Porto Alegre /ID# 157670

location_facility: Soroka University Medical Center /ID# 171093

location_facility: Pauls Stradins Clinical University Hospital /ID# 160205

location_facility: Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 158736

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 159466

location_facility: The University of Chicago Medical Center /ID# 160511

location_facility: Hospital Universitario La Paz /ID# 159471

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 158046

location_facility: CHU Amiens-Picardie Site Sud /ID# 207880

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 164029

location_facility: Fırat University Medical Facul /ID# 171285

location_facility: Tzaneio general hospital of Piraeus /ID# 206437

location_facility: ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211450

location_facility: UMHAT Tsaritsa Joanna - ISUL /ID# 209978

location_facility: Interdisctrict Multidisciplinary Hospital /ID# 204921

location_facility: Fakultni nemocnice u sv. Anny v Brne /ID# 239158

location_facility: Perm Clinical Center of the Federal Medical and Biological Agency /ID# 227456

location_facility: Texas Digestive Disease Consultants /ID# 209951

location_facility: Fukuoka University Chikushi Hospital /ID# 209056

location_facility: Medizinische Universitaet Wien /ID# 169051

location_facility: The Chaim Sheba Medical Center /ID# 211279

location_facility: Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 215505

location_facility: University Clinical Center Serbia /ID# 200153

location_facility: Ulyanovsk Regional Clinical Hospital /ID# 204923

location_facility: Private Practice Dr MN Rajabally /ID# 171141

location_facility: Nagasaki University Hospital /ID# 205326

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 170959

location_facility: Columbia Univ Medical Center /ID# 161929

location_facility: Aichi Medical University Hospital /ID# 164227

location_facility: VA Caribbean Healthcare System /ID# 222779

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159379

location_facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 210508

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 210814

location_facility: Centro Hospitalar e Universitario de Coimbra, EPE /ID# 166050

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 207883

location_facility: Adult Gastroenterology Associates - Gen 1 Research /ID# 208873

location_facility: Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 166563

location_facility: Peak Gastroenterology Associates, PC /ID# 165838

location_facility: National Hospital Organization Takasaki General Medical Center /ID# 164312

location_facility: Hospital Universitario de Salamanca /ID# 159469

location_facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 169122

location_facility: National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 203513

location_facility: Osaka Medical and Pharmaceutical University Hospital /ID# 226036

location_facility: The First Affiliated Hospital of Anhui Medical University /ID# 211227

location_facility: Theageneio Anticancer Hospital /ID# 165329

location_facility: Complejo Hospitalario Universitario de Pontevedra /ID# 216183

location_facility: Kanazawa University Hospital /ID# 169221

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226796

location_facility: Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 207041

location_facility: Hospital Universitario Reina Sofia /ID# 167062

location_facility: Hyogo College of Medicine College Hospital /Id# 164238

location_facility: Medizinische Universitaet Graz /ID# 169052

location_facility: Hadassah Medical Center-Hebrew University /ID# 171092

location_facility: Toronto Digestive Disease Asso /ID# 169120

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 171223

location_facility: Clinical Hosp Center Zvezdara /ID# 200150

location_facility: Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224100

location_facility: Saiseikai Fukuoka Genaral Hospital /ID# 225640

location_facility: The Second Xiangya Hospital of Central South University /ID# 211196

location_facility: Uludag University Medical Faculty /ID# 204179

location_facility: Yale Univ Digestive Diseases /ID# 213265

location_facility: Barnsley Hospital NHS Foundation Trust /ID# 202771

location_facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211070

location_facility: ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155623

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 211069

location_facility: Penn State Milton S. Hershey Medical Center /ID# 230474

location_facility: Cotton-O'Neil Clinical Res Ctr /ID# 160367

location_facility: Robley Rex VA Medical Center /ID# 218647

location_facility: Central Clinical Hospital RZHD Medicine /ID# 204922

location_facility: Asahikawa Medical University Hospital /ID# 164324

location_facility: Gastroenterology Group Naples /ID# 165210

location_facility: Kyiv Municipal Clinical Hospital #18 /ID# 224347

location_facility: Hospital Universitario San Vic /ID# 171488

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 157668

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 200256

location_facility: DiGiovanna Institute for Medical Education & Research /ID# 171128

location_facility: Immanuel Kant Baltic Federal University /ID# 204920

location_facility: Kuzbass Regional Clinical Hospital /ID# 165759

location_facility: Hospital Alvaro Cunqueiro CHUVI /ID# 167359

location_facility: Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 165578

location_facility: KL Ling Gastroenterology and Liver Clinic /ID# 206563

location_facility: Linkou Chang Gung Memorial Hospital /ID# 222878

location_facility: Unidad de Atencion Medica e Investigacion en Salud /ID# 206515

location_facility: Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 211062

location_facility: St.Luke's International Hospital /ID# 225969

location_facility: Toho University Sakura Medical Center /ID# 164219

location_facility: Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 211230

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 170286

location_facility: Ospedale Sant Orsola Malpighi /ID# 155627

location_facility: General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 165313

location_facility: Taichung Veterans General Hospital /ID# 171433

location_facility: Hayang University GuriHospital /ID# 158661

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 201824

location_facility: Ctr for Advanced Gastroenterol /ID# 202820

location_facility: Praxiszentrum fuer Gastroenterologie /ID# 219072

location_facility: Hamamatsu University Hospital /ID# 226729

location_facility: Groupe Sante CHC - Clinique du MontLegia /ID# 200255

location_facility: Gastro Health & Nutrition - Victoria /ID# 164308

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170910

location_facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 159463

location_facility: Kitasato University Kitasato Institute Hospital /ID# 164222

location_facility: Cabinet Particular Policlinic Algomed /ID# 171260

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 207882

location_facility: Sahlgrenska University Hospital Molndal /ID# 202841

location_facility: The Sixth Affiliated Hosp Sun /ID# 211229

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 165577

location_facility: CHRU Nancy - Hôpitaux de Brabois /ID# 207877

location_facility: Nagoya City University Hospital /ID# 164229

location_facility: UOC Medicina Interna e Gastroe /ID# 155624

location_facility: East Tennessee Research Institute /ID# 168744

location_facility: Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 224349

location_facility: National Taiwan University Hospital /ID# 162188

location_facility: Stadtisches Klinikum Braunschweig /ID# 163694

location_facility: Medical Research Center of CT /ID# 160287

location_facility: Digestive Disease Associates, LTD /ID# 232406

location_facility: LMU Klinikum Campus Grosshadern /ID# 210484

location_facility: Yeungnam University Medical Center /ID# 158662

location_facility: Hospital Privado Univesitario /ID# 167802

location_facility: Great Lakes Medical Research, LLC /ID# 201778

location_facility: China Medical University Hospital /ID# 160194

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 169118

location_facility: Klinicki bolnicki centar Zagreb /ID# 201915

location_facility: Universitaetsklinikum Erlangen /ID# 159373

location_facility: Huai'an First People's Hospital /ID# 239197

location_facility: Universitair Ziekenhuis Leuven /ID# 170829

location_facility: Taipei Veterans General Hosp /ID# 171436

location_facility: South Lake Pain Institute, Inc /ID# 162859

location_facility: Scott Shulman Medicine Professional Corporation /ID# 169127

location_facility: Gokeikai Ofuna Chuo Hospital /ID# 169296

location_facility: CHA University Bundang Medical Center /ID# 158669

location_facility: First Moscow State Medical University n.a I.M. Sechenov /ID# 204981

location_facility: Ponce Medical School Foundation /ID# 222825

location_facility: Liverpool University Hospitals NHS Foundation Trust /ID# 203860

location_facility: Showa University Fujigaoka Hospital /ID# 209606

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 163389

location_facility: Praxis fuer Gastroenterologie /ID# 166154

location_facility: Advanced Research Institute, Inc /ID# 161945

location_facility: Clinical Research Trials of Florida, Inc. /ID# 201794

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 167202

location_facility: International Medical Center SOGAZ /ID# 206832

location_facility: Gastroenterologische Gemeinschaftspraxis Minden /ID# 162037

location_facility: Quality Clinical Research Inc. /ID# 167312

location_facility: Air Force Specialized Hospital /ID# 170984

location_facility: Texas Digestive Disease Consultants /ID# 209799

location_facility: MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159380

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 158230

location_facility: Hospital Clinic de Barcelona /ID# 159462

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 211024

location_facility: A.O. Per L'Emergenza Cannizzaro /ID# 164039

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 160457

location_facility: Tokyo Medical And Dental University Hospital /ID# 164225

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 157683

location_facility: St George's University Hospitals NHS Foundation Trust /ID# 208379

location_facility: King's College Hospital NHS Foundation Trusts /ID# 158762

location_facility: CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 224344

location_facility: Inonu Universitesi Turgut Ozal /ID# 203980

location_facility: Hospital Provincial del Centenario /ID# 170896

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226795

location_facility: Louisana Research Center, LLC /ID# 201205

location_facility: General Hospital of Athens Ippokratio /ID# 229190

location_facility: Sapporo Higashi Tokushukai Hospital /ID# 208493

location_facility: St. Marianna University Hospital /ID# 226730

location_facility: GBUZ Allergology and Immunology Center of Ministry of Health of Kabardino-Bal /ID# 233974

location_facility: Agaplesion Markus Krankenhaus /ID# 159375

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 158047

location_facility: Universitaetsklinikum Regensburg /ID# 163693

location_facility: Fujita Health University Hospital /ID# 164313

location_facility: Hospital Guillermo Grant Benavente de Concepción /ID# 210762

location_facility: Gastroenterologie Opernstrasse /ID# 163690

location_facility: Rocky Mountain Pediatric Gastroenterology /ID# 207173

location_facility: Odense Universitets Hospital /ID# 209502

location_facility: Hiroshima University Hospital /ID# 164240

location_facility: Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 219146

location_facility: Duplicate_Universitaetsklinikum St.Poelten /ID# 169049

location_facility: Vilnius University Hospital Santaros Klinikos /ID# 201144

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200934

location_facility: DM Clinical Research/Southwest /ID# 165009

location_facility: Lenus Research & Medical Group /ID# 169727

location_facility: The Catholic University of Korea, ST. Vincent's Hospital /ID# 158664

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 158020

location_facility: Azienda Ospedaliera San Camillo Forlanini /ID# 155628

location_facility: Erciyes University Medical Fac /ID# 171283

location_facility: London Health Sciences Center /ID# 169117

location_facility: Duplicate_Centrul Medical Tuculanu SRL /ID# 171263

location_facility: Hoag Memorial Hosp Presbyterian /ID# 218347

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 207881

location_facility: Gastroenterology Consultants of Southwest Virginia /ID# 218142

location_facility: General Hospital of Athens Laiko /ID# 206438

location_facility: The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 242379

location_facility: Clinic of New Technologies of Medicine /ID# 204926

location_facility: Universitatsklinikum Mannheim /ID# 162039

location_facility: Elisabeth Tweesteden Ziekenhuis /ID# 163738

location_facility: Shiga University of Medical Science Hospital /ID# 164323

location_facility: West China Hospital, Sichuan University /ID# 211275

location_facility: Universitaetsklinikum Freiburg /ID# 162038

location_facility: Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 224927

location_facility: Tyler Research Institute, LLC /ID# 166799

location_facility: Sisli Etfal Train & Res Hosp /ID# 171415

location_facility: Percuro Clinical Research, Ltd /ID# 169123

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Panstwowy Instytut Bada /ID# 170285

location_facility: Kitasato University Hospital /ID# 169223

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 159430

location_facility: Nara Medical University Hospital /ID# 169222

location_facility: Nemocnice Ceske Budejovice a.s. /ID# 225228

location_facility: Virginia Mason Medical Center /ID# 160432

location_facility: Sjællands Universitetshospital /ID# 200073

location_facility: Hospital Nossa Senhora das Graças /ID# 157677

location_facility: Atrium Health Carolinas Medical Center /ID# 158543

location_facility: CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 214379

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 201142

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 223781

location_facility: Tokai University Hachioji Hospital /ID# 227102

location_facility: Hospital Garcia de Orta, EPE /ID# 165579

location_facility: Southern Star Research Institute, LLC /ID# 168774

location_facility: Hospital Universitario Miguel Servet /ID# 159468

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 169770

location_facility: South Florida Research Ph I-IV, Inc. /ID# 161844

location_facility: General Hospital of Ningxia Medical University /ID# 213912

location_facility: Royal Devon and Exeter NHS Trust Hospital /ID# 157614

location_facility: Yokkaichi Hazu Medical Center /ID# 164316

location_facility: Health Pharma Professional Research S.A de C.V /ID# 206516

location_facility: Chung Shan Medical University Hospital /ID# 171426

location_facility: Southern California Res. Ctr. /ID# 169659

location_facility: Azienda Ospedaliero-Universitaria di Modena /ID# 201818

location_facility: Colo-proctology Center Matsushima Clinic /ID# 225915

location_facility: Renmin Hospital of Wuhan University /ID# 212867

location_facility: Yamagata University Hospital /ID# 171481

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 164215

location_facility: UCSF Center for Colitis and Crohn's Disease /ID# 201209

location_facility: Ospedale Policlinico San Martino /ID# 164030

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 217479

location_facility: Yonsei University Health System Severance Hospital /ID# 158660

location_facility: Hospital Universitario Virgen Macarena /ID# 159969

location_facility: National Hospital Organization Hirosaki General Medical Center /ID# 164216

location_facility: Klinicki bolnicki centar Split /ID# 157596

location_facility: The First Affiliated Hospital of Nanchang University /ID# 212182

location_facility: Pusan National University Hospital /ID# 158670

location_facility: Faculdade de Medicina do ABC /ID# 163993

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210960

location_facility: Cedars-Sinai Medical Center-West Hollywood /ID# 163848

location_facility: H-T. Centrum Medyczne - Endoterapia /ID# 231501

location_facility: Centro Hospitalar de Entre Douro e Vouga /ID# 166048

location_facility: Complejo Asistencial Dr. Sotero del Rio /ID# 169386

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 216043

location_facility: Regional Clinical Hospital #1 /ID# 165763

location_facility: The Jikei University Hospital /ID# 164279

location_facility: Wakayama Medical University Hospital /ID# 169485

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 160513

summary:
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.

This study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic.


title: Evaluation of the VQ11 Auto-questionnaire of Quality of Life in Pneumology Investigation, During the Implementation of a Long-acting Bronchodilator Treatment of Patients With COPD.

acronym: EPIC

summary:
The purpose of this study is to estimate the capacity of the auto-questionnaire of quality of life, VQ11, to follow the evolution of patients with COPD (Chronic obstructive pulmonary disease) in stable state (without exacerbation in the previous 6 weeks) (3 months +/-15 days) during the implementation of a LABD (Long-acting bronchodilator) treatment.

The main objective is to compare the total Score of the VQ11 auto-questionnaire before and after LABD. A decrease of 5 points of the total score mimicking an improvement in the quality of life linked to health, specifically in the COPD.

status: Completed

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CH Creil
Hopital Maison Blanche
CHU de Rouen
Hopital Jacques MONOD
CHU Amiens Sud
Clinique de l'Europe
Centre Médical
CH de DOUAI
Centre Hospitalier de Chauny
Zac Gouraud
CHU Amiens Nord
Centre Hospitalier de Compiègne
Résidence Saint Michel
CHRU de Lille
Centre hospitalier de St Quentin

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Prevention of Oversedation in Intensive Care Patients Under Mechanical Ventilation : the AWARE Multicentric Randomized Trial

acronym: AWARE

summary: The purpose of the present study is to determine whether administration of sedation according to a strategy including a bundle of measures to prevent oversedation is associated with a reduction in mortality of intensive care unit patients requiring mechanical ventilation, compared to administration of sedation according to usual practices.

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Payen JF, Chanques G, Mantz J, Hercule C, Auriant I, Leguillou JL, Binhas M, Genty C, Rolland C, Bosson JL. Current practices in sedation and analgesia for mechanically ventilated critically ill patients: a prospective multicenter patient-based study. Anesthesiology. 2007 Apr;106(4):687-95; quiz 891-2.

ReferenceCitation: Kollef MH, Levy NT, Ahrens TS, Schaiff R, Prentice D, Sherman G. The use of continuous i.v. sedation is associated with prolongation of mechanical ventilation. Chest. 1998 Aug;114(2):541-8.

ReferenceCitation: Constantin JM, Chanques G, De Jonghe B, Sanchez P, Mantz J, Payen JF, Sztark F, Richebé P, Lagneau F, Capdevila X, Bazin JE, Lefrant JY. [Current use of sedation and analgesia: 218 resuscitations in France services practices survey]. Ann Fr Anesth Reanim. 2010 May;29(5):339-46. doi: 10.1016/j.annfar.2010.01.014. Epub 2010 Apr 13. French.

ReferenceCitation: Brook AD, Ahrens TS, Schaiff R, Prentice D, Sherman G, Shannon W, Kollef MH. Effect of a nursing-implemented sedation protocol on the duration of mechanical ventilation. Crit Care Med. 1999 Dec;27(12):2609-15.

ReferenceCitation: De Jonghe B, Bastuji-Garin S, Fangio P, Lacherade JC, Jabot J, Appéré-De-Vecchi C, Rocha N, Outin H. Sedation algorithm in critically ill patients without acute brain injury. Crit Care Med. 2005 Jan;33(1):120-7.

ReferenceCitation: Quenot JP, Ladoire S, Devoucoux F, Doise JM, Cailliod R, Cunin N, Aubé H, Blettery B, Charles PE. Effect of a nurse-implemented sedation protocol on the incidence of ventilator-associated pneumonia. Crit Care Med. 2007 Sep;35(9):2031-6.

ReferenceCitation: Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7.

ReferenceCitation: Strøm T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29.

ReferenceCitation: Treggiari MM, Romand JA, Yanez ND, Deem SA, Goldberg J, Hudson L, Heidegger CP, Weiss NS. Randomized trial of light versus deep sedation on mental health after critical illness. Crit Care Med. 2009 Sep;37(9):2527-34. doi: 10.1097/CCM.0b013e3181a5689f.

ReferenceCitation: Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62.

ReferenceType: derived

ReferenceCitation: SRLF Trial Group. Impact of oversedation prevention in ventilated critically ill patients: a randomized trial-the AWARE study. Ann Intensive Care. 2018 Sep 21;8(1):93. doi: 10.1186/s13613-018-0425-3.

lead_sponsor: French Society for Intensive Care

location_facility:
CH Leon Binet
Hopital Delafontaine
CHU Kremlin-Bicetre
CH de la Région d'Annecy
CHRU de la Cavale Blanche
Hopital l'Archet
CHU Henri Mondor
Hopital Jean Bernard
CH Sud Francilien
Hopital Ambroise Pare
Hopital Antoine Beclere
Hopital Notre-Dame de Bon Secours
CH Princesse Grace
Hopital St-Andre
CH Germon et Gauthier
CHD Les Oudairies
GHIRM
Hopital Laennec
CHR d'Orléans Hopital la Source
Institut Mutualiste Montsouris
CH St-Joseph St-Luc
Hopital Avicenne
CH de Versailles
HIA Béjin
CH de St-Brieuc
CHU Marseille Hopital Nord
Groupe Hospitalier Edouard Herriot
Institut Gustave Roussy
CH Francois Miterrand
CH d'Argenteuil
CHRU Bretonneau
Hopital St Louis
CH Poissy
Hopital de la Timone
CH de Meaux
Hopital Privé d'Antony
Hopital Tenon
Hopital Raymond Poincare
CH de Pontoise
Hôpital Saint-Esprit
Hopital Roger Salengro
CHU d'Angers
CH de St-Malo

intervention_type: Procedure


title: Interest of the Prophylactic Cerebral Radiotherapy in the Metastatic Breast Cancer Expressing HER2/NEU Treated by Trastuzumab

acronym: TSARINE

summary: Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.

lead_sponsor: Centre Oscar Lambret

location_facility:
Oncorad Garonne
Centre Hospitalier
Centre de Cancérologie Paris Nord
Clinique Hartmann
Centre Hospitalier de Mulhouse
CHU Dupuytren
Centre Etienne DOLET
Centre Léonard de Vinci
Centre Azuréen de Cancérologie
Centre Maurice Tubiana
Clinique Clinique Clementville
Centre Antoine Lacassagne
Centre Médical de Forcilles
Institut Gustave Roussy
Clinique des Ormeaux- Vauban
Centre médical Oncogard
Centre René Huguenin
Hôpital Tenon
Centre Alexis Vautrin
Centre Hospitalier LYON SUD
Centre G-François Baclesse
Centre Catherine de Sienne
Centre Bourgogne
Centre Oscar LAMBRET
Centre Paul Papin
Centre Catalan d'Oncologie

intervention_type: Radiation


title: Randomized Double Blind Placebo-controlled Phase II Trial of Vargatef® (Nintedanib) in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Adenocarcinoma of the Ovary, the Fallopian Tube or Serous Adenocarcinoma of the Peritoneum

acronym: CHIVA

summary:
Patients with extensive and bulky disease are often those whose initial surgery is delayed after 3 or 4 cycles of neo-adjuvant chemotherapy.

In that case, there is, indeed, some concern to administer bevacizumab during the chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21 days) of this monoclonal antibody and the interference of anti angiogenic agents with wound healing.

Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary experience in cancer did not show a trend for increased incidence of fistula or bowel perforation. For more details please refer to the investigator drug brochure for Vargatef® (Nintedanib).

This trial will compare progression-free survival and surgical complications of 188 patients with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy (carboplatin & paclitaxel) and interval debulking surgery or the same treatment + Vargatef® (Nintedanib).

ReferenceCitation: Aide N, Fauchille P, Coquan E, Ferron G, Combe P, Meunier J, Alexandre J, Berton D, Leary A, De Rauglaudre G, Bonichon N, Pujade Lauraine E, Joly F. Predicting tumor response and outcome of second-look surgery with (18)F-FDG PET/CT: insights from the GINECO CHIVA phase II trial of neoadjuvant chemotherapy plus nintedanib in stage IIIc-IV FIGO ovarian cancer. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):1998-2008. doi: 10.1007/s00259-020-05092-3. Epub 2020 Nov 21.

ReferenceCitation: Robelin P, Tod M, Colomban O, Lachuer J, Ray-Coquard I, Rauglaudre G, Joly F, Chevalier-Place A, Combe P, Lortholary A, Hamizi S, Raban N, Ferron G, Meunier J, Berton-Rigaud D, Alexandre J, Kaminsky MC, Dubot C, Leary A, Malaurie E, You B. Comparative analysis of predictive values of the kinetics of 11 circulating miRNAs and of CA125 in ovarian cancer during first line treatment (a GINECO study). Gynecol Oncol. 2020 Oct;159(1):256-263. doi: 10.1016/j.ygyno.2020.07.021. Epub 2020 Jul 22.

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Huriez

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Milétrie - Centre Hospitalier Universitaire de Poitiers

location_facility: Centre Hospitalier Universitaire Dupuytren


ipd_sharing: No

acronym: DIONE

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

lead_sponsor: Theravance Biopharma

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

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

location_facility: Theravance Biopharma Investigational Site

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.


title: Safety of Nivestim® in Patients Treated With Neutropenia-inducing Anticancer Chemotherapy in Routine Practice

summary: The main aim of the study is to assess the safety of Nivestim® treatment in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Kamioner D, Fruehauf S, Maloisel F, Cals L, Lepretre S, Berthou C. Study design: two long-term observational studies of the biosimilar filgrastim Nivestim™ (Hospira filgrastim) in the treatment and prevention of chemotherapy-induced neutropenia. BMC Cancer. 2013 Nov 16;13:547. doi: 10.1186/1471-2407-13-547.

lead_sponsor: Hospira, now a wholly owned subsidiary of Pfizer

location_facility:
CHU Purpan
Clinique Ste Marguerite
Centre Rene Huguenin
Clinique St Faron
CHG Dieppe
Inst. Claudius Regaud
Polyclinique Cesson
H.I.A Saint Anne
HARTMANN
Centre Oscar Lambret
Clinique des Bonnettes
Chu Gabriel Montpied
Clinique CONVERT
Chg St Jean
CHRA
Chp Clairval
Chu Rennes
Chu Timone
Hpt Rene Dubos
Chu Grenoble
Clinique des Dentellieres
CH Jacques Monod
CHI de Fréjus
Clinique du Cap d'Or
Saint Antoine
Chu Estaing
Ch Duffaut
Chr Brive
CHU du BOCAGE
Clinique Beausoleil
CH Boulogne-sur-Mer
Clinique St Laurent
Clinique de l'Ormeau
Chu Hopital Civil
Clinique Ste Marie
Saint Louis
Hopital Foch
MEDIPOLE
Ch Valence
Clinique Pasteur
Chp St Greg
Cac Jean Godinot
Chi Frejus - St Raphael
Hopital Des Courses
Ch Cholet
Victor Hugo
Hopital Louis Pasteur
CH Emile Muller
CHG St Gaudens
CAC Paul Strauss
TENON
CHG Cahors
Hopital Troyes
Hopital A.Pare
STE ANNE
Chu St Eloi
CHR
CH Sainte Musse
Clinique Porte St Cloud
CHG
Ico Angers
Clinique Vitalia Desertines
CHU SUD
Clinique Belvédère
CHG William MOREY
Victor Dubos
BEAUJON
Ch St Malo
Hopital Franco Britannique
IPC
Hopital Mignot
Clinique Rambot
Icl St Etienne
Ch Chambery
Hopital Jean Monnet
Pole Sante Republique
CHICAS
Hopital St Quentin
Centre frederic joliot curie
CHU Caremeau
Ch Le Mans
CH de Draguignan
Fondation Saint Joseph
Ch Du Pays D'Aix


title: Randomized Cross Over Double Blind Versus Placebo Trial Followed by an Open Phase Studying Effect of Norditropin® on Left Ventricular Mass of Growth Hormone Deficient Adult Patients

summary: This trial is conducted in Europe. The aim of this trial is to assess the effect of somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients with a growth hormone deficiency.

lead_sponsor: Novo Nordisk A/S


title: A Multicentre Prospective Phase II Single Arm Trial Evaluating the Benefit of Therapy With Lenalidomide (Revlimid®) in Relapsed or Refractory Primary-cutaneous Large B-cell Lymphoma (Leg-type) After First Line Treatment by Chemotherapy Plus Rituximab for the French Study Group of Cutaneous Lymphoma (GFELC)

acronym: REV-LEG

summary:
In spite of high initial response rate after a first line treatment by R-polychemotherapy, cutaneous but also extra-cutaneous recurrences occur after 2 years in about half of the patients with PCBCL-LT. Thereafter there is no consensus concerning patients care: radiotherapy has only a palliative effect, advanced age often limits using more aggressive chemotherapies and no treatment has demonstrated a prolonged efficacy in these relapsing cases. Therefore new alternatives therapeutic options are needed. Lenalidomide has an antineoplastic pro-apoptotic effect but also immunomodulatory, and antiangiogenic properties. Preliminary results suggest its efficacy in relapsing or refractory diffuse large B-cells lymphomas, especially of nongerminal cells phenotype. By analogy with these results, lenalidomide appears as an attractive candidate in PCLBCL-LT, more specially as it has a manageable toxicity even in advanced age patients.

If the lenalidomide efficacy is confirmed in relapsing PCLBCL-LT, this will plead its evaluation as maintenance therapy after R-chemotherapy in order to avoid recurrences.

lead_sponsor: University Hospital, Bordeaux

location_facility: AP-HP Groupe hospitalier Bichat - Claude Bernard


title: End-of-life in French Intensive Care Units: Perception of the Quality of Dying and Experience of Physicians, Nurses and Relatives. Validation of the CAESAR Scale

acronym: CAESAR

summary:
The purpose of the study is to evaluate the quality of the dying process in french ICUs (assessed by the CAESAR scale) and to compare physicians', nurses' and relatives perceptions and experiences, with a one-year follow-up of bereaved relatives.

Our hypothesis is that perception of the quality of dying may impact on relatives' experience of bereavement (anxiety, depression, complicated grief, posttraumatic stress disorder (PTSD)).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Réanimation polyvalente CH Sud Francilien

location_facility: Service d'anesthésie et de réanimation Hôpital Nord

location_facility: Service de réanimation Hôpital Saint Joseph

location_facility: Réanimation Médicale Groupement Hospitalier Edouard Herriot

location_facility: Service de réanimation, détresses respiratoires et infections sévères Hôpital Nord

location_facility: Anesthésie-Réanimation CHU de Nantes- Hôtel Dieu

location_facility: Service de réanimation médico-chirurgicale Institut Gustave Roussy

location_facility: Réanimation polyvalente Hôpital Les Oudairies

location_facility: Reanimation medicale, Hôpital Saint Louis

location_facility: Réanimation chirurgicale Hôpital Saint-Louis

location_facility: Réanimation polyvalente GH Edouard Herriot

location_facility: Réanimation polyvalente Hôpital Roger Salengro

location_facility: Service de réanimation médicale Hôpital Victor Provo

location_facility: Réanimation médicale CHU de la Cavale Blanche

location_facility: Réanimation Centre hospitalier Marc Jacquet

location_facility: Service d'anesthésie et de réanimation Chu Timone

location_facility: Réanimation polyvalente Centre hospitalier d'Angoulême

location_facility: Réanimation Polyvalente Centre Hospitalier Victor Dupouy

location_facility: Réanimation médico-chirurgicale CH de Roanne

location_facility: Réanimation médicale Centre hospitalier Pays d'Aix

location_facility: Réanimation médicale Hôpital Saint André

location_facility: Service de réanimation polyvalente CH de Valenciennes

location_facility: Service de réanimation médicale CHU CH Nicolle

location_facility: Réanimation Centre Hospitalier Intercommunal André Grégoire

location_facility: Service de réanimation polyvalente CH de Saint Lô

location_facility: Réanimation Polyvalente CH Bretagne Atlantique

location_facility: Réanimation médicale CHU de Nancy- Hôpital central

location_facility: Réanimation Médico-Chirugicale CH Chambéry

location_facility: Service de réanimation polyvalente CHR - Hôpital de la Source

location_facility: Réanimation polyvalente Centre hospitalier de Versailles

location_facility: réanimation chirurgicale Groupe Hospitalier Universitaire Carémeau

location_facility: Service de réanimation médicale et toxicologique CHU Lariboisière

location_facility: Service de réanimation Institut Paoli Calmettes

location_facility: Réanimation Polyvalente Centre Hospitalier de Gonesse

location_facility: Neuro-réanimation chirurgicale Groupe hospitalier Pitié-Salpêtrière

location_facility: Réanimation médicale Hôpital de La Croix Rousse


title: The Medical-financial Evaluation of Pre-therapeutic Screening by a Joint Phenotypic-pharmacogenetic Approach for Metabolic Fluoropyrimidine Enzyme Deficiency in Terms of Serious Toxicity Risk Prevention : a Multicentric Case Study

acronym: DPD côlon

summary: The aim of this study is to demonstrate the medical and financial benefit of pre-therapeutic screening of DPD deficiency for predicting toxicity to fluoropyrimidines.

design_allocation: Non-Randomized

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Centre Hospitalier
CH Sarthe et Loir
Centre Oscar Lambret
CHU Côte de Nacre
Centre François Baclesse
CHU Trousseau
ICO Paul Papin
Clinique des Cèdres
Centre Antoine Lacassagne
Centre Hospitalier Lyon Sud
Institut Claudius Regaud
Pôle Santé Léonard de Vinci
HEGP
Centre Hospitalier du Haut Anjou
CHU Hotel Dieu
ICO René Gauducheau
Hôpital Purpan
CHU Morvan
CHU Jean Minjoz
Centre Hospitalier Les oudairies
Centre d'oncologie de Gentilly
Hôpital Henri Mondor

intervention_type: Genetic


acronym: Antibody persistence to REVAXIS or DT Polio and Immune response to TETRAVAC-ACELLULAIRE

title: Antibody Persistence in 11 to 13-year-old Children Previously Vaccinated at 6 Years Old With Either REVAXIS or DT Polio, and Immune Response to a Booster Dose of TETRAVAC-ACELLULAIRE

lead_sponsor: Sanofi Pasteur, a Sanofi Company

location_facility:
SPMSD Investigational Site 124
SPMSD Investigational Site 121
SPMSD Investigational Site 199
SPMSD Investigational Site 136
SPMSD Investigational Site 197
SPMSD Investigational Site 161
SPMSD Investigational Site 147
SPMSD Investigational Site 103
SPMSD Investigational Site 155
SPMSD Investigational Site 125
SPMSD Investigational Site 193
SPMSD Investigational Site 145
SPMSD Investigational Site 123
SPMSD Investigational Site 198
SPMSD Investigational Site 148
SPMSD Investigational Site 128
SPMSD Investigational Site 129
SPMSD Investigational Site 135
SPMSD Investigational Site 139
SPMSD Investigational Site 133
SPMSD Investigational Site 101
SPMSD Investigational Site 106
SPMSD Investigational Site 117
SPMSD Investigational Site 141
SPMSD Investigational Site 130
SPMSD Investigational Site 163
SPMSD Investigational Site 150
SPMSD Investigational Site 140
SPMSD Investigational Site 157
SPMSD Investigational Site 153
SPMSD Investigational Site 102
SPMSD Investigational Site 162
SPMSD Investigational Site 152
SPMSD Investigational Site 164
SPMSD Investigational Site 116
SPMSD Investigational Site 107
SPMSD Investigational Site 194
SPMSD Investigational Site 160
SPMSD Investigational Site 120
SPMSD Investigational Site 113
SPMSD Investigational Site 114
SPMSD Investigational Site 151
SPMSD Investigational Site 134
SPMSD Investigational Site 110
SPMSD Investigational Site 115

summary:
PRIMARY OBJECTIVES

To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and poliovirus types 1, 2 and 3
To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses against diphtheria, tetanus, and poliovirus types 1, 2 and 3

SECONDARY OBJECTIVES

To describe other parameters of the antibody persistence against diphtheria, tetanus and poliomyelitis antigens
To describe other parameters of the immune responses to diphtheria, tetanus and poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE
To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE


title: Confirmation of the Antiviral Effects of Midodrine Identified With a Gene Expression Signature-based Screening of Inluenza A Virus Infected Cells

acronym: FLUMED

summary:
Rationale:

Classical antiviral therapies target viral proteins and are consequently subject to resistance. To counteract this limitation, alternative strategies have been developed that target cellular factors. We hypothesized that such an approach could also be useful to identify broad-spectrum antivirals. The influenza A virus was used as a model for its viral diversity and because of the need to develop therapies against unpredictable viruses as recently underlined by the H1N1 pandemic. Gene-expression signature-based screening identified broadly effective influenza A antivirals. Midodrine showed great results in inhibiting viral growth and was the most suited to confirm its efficacy in vivo.

The main objective of the study is to assess the efficacy of midodrine taken at usual recommended dose (7.5mg/day) versus no treatment on viral replication kinetics of virus Influenza A.

Secondary objectives: evaluation of the number of patients with a normalized viral load 2, 3 5 and 7 days post-treatment; description of the anti-viral efficacy of midodrine defined as the delay to obtain a prolonged negativity of viral RNA; description of the tolerance of midodrine, evaluation of the clinical response to study treatment; evaluation of the dynamic of viral replication; analysis of the frequency of emergence of mutants and associated resistance.

Methods:

This is a multicenter, randomized, open-label study comparing patients aged 18 to 65 years infected by influenza A virus. Nasopharyngeal washing will be performed at day 0 (randomization), 2, 3, 5 to show the viral replication evolution.

161 patients will be randomized as follows :

Arm 1 : Midodrine, 2.5 mg, 3 times a day
Arm 2 : No treatment The recruitment is performed by general practitioners in the Lyon area.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital D'Instruction des Armées Desgenettes


title: Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device

summary: A surgery made by an external incision requires to stitch the subcutaneous plans, usually performed using absorbable synthetic sutures hold on wire needle. This national, prospective, multicentric, and randomized study is devoted to estimate a technique of suture of the subcutaneous plans based on an implantable medical device delivering automatically absorbable staples. This particularly innovative technique lets to expect a tolerance and an efficiency at least equivalent to the reference technique (main objective). Moreover, this technique allows to anticipate a reduction of the duration of surgical procedure and anesthetic time while limiting the risks of blood wounds of the medical staff.The medical economic part of this study will check, from the point of view of the health care hospital, wether the technique is likely to reduce the costs and time consuming theater room procedures.

lead_sponsor: Nantes University Hospital

location_facility: Lille University Hospital "Hôpital Roger Salengro"

location_facility: Brest University Hospital "Hôpital du Morvan"

location_facility: Rennes University Hospital "CHU Pontchaillou"

location_facility: Bordeaux University Hospital "Centre FX. Michelet"

location_facility: Strasbourg University Hospital "Hôpital Hautepierre"

location_facility: Montpellier University Hospital "Hôpital Gui de Chauliac"

location_facility: "Assistance Publique des Hôpitaux de Marseille - La Conception"

location_facility: "Assistance Publique des Hôpitaux de Paris - Hôpital Bichat"

location_facility: Caen University Hospital "Hôpital de la Côte de Nacre"

intervention_type: Device


title: Impact of Amantadine on L-DOPA-induced Dyskinesia in Early Parkinson's Disease: a Placebo-controlled Randomized Study (the PREMANDYSK Study)

acronym: PREMANDYSK

summary: Traditionally amantadine is used at the beginning of Parkinson Disease (PD) treatment in the early stages of the disease, as a modest antiparkinsonian symptomatic treatment. This treatment is usually maintained for no more than the first few months of management, before resorting to drugs deemed more effective as dopamine agonists and lévo-DOPA (L-DOPA). A more modern use of the drug is at a more advanced stage of PD when dyskinesia are already established and become disabling for the patients. There is no data between these two extremes of life stages of Parkinsonism. However, the mechanisms of action of amantadine and the pathophysiology of the motor complications induced by L-DOPA, in particular dyskinesia suggest that the early and prolonged use of amantadine in the early years of management, before L-DOPA-induced dyskinesia have already emerged, should have a positive impact on long-term occurrence and fate of these symptoms, possibly through a glutamatergic mechanism of brain plasticity-of the "disease modification" type.

lead_sponsor: University Hospital, Toulouse

location_facility:
CH Charles Nicolle
CHU Clermont-Ferrand
CHG Aix en Provence
Hopital pitié Salpétriére
CHU Lille
Hopital de la Timone
hopital Saint Eloi
CHu de Nantes
Hopital Lyon
Hopital Jean Bernard
CHU de Strasbourg
CHU de Toulouse
CH Montauban
CH Jean Rougier
CHU de Bordeaux
CH de Narbonne
CHU Dupuytren
CHU Dijon


title: An Open Label Phase II Study to Evaluate the Efficacy and Safety of Induction and Consolidation Therapy With Nilotinib in Combination With Chemotherapy in Patients Aged 55 Years and Over With Philadelphia Chromosome Positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL)

summary: The goal of this trial is to evaluate the efficacy and the tolerance of the combination of nilotinib with chemotherapy in the front-line setting as induction and consolidation therapy in Ph+ ALL patient aged 55 years and over. A European consensus has been reached to adopt a common chemotherapeutic schedule for patients aged 55 years and over. This schedule will be used in this trial with the addition of nilotinib as concomitant therapy during induction, consolidation and maintenance. The patients will be prospectively monitored for minimal residual disease and bcr-abl tyrosine kinase domain mutations.

lead_sponsor: Goethe University

location_country: Germany France Spain

location_facility: Hospital Universitario 12 de Octubre (Madrid)

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: CHRU de Strasbourg - Hôpital Hautepierre

location_facility: Groupe Hospitalier de l'Institut Catholique de Lille, hôpital Saint-Vincent

location_facility: "Institut Universitaire du Cancer (CHU de Toulouse - Hôpital Purpan)"

location_facility: Hospital Universitario y Politécnico La Fe (Valencia)

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

location_facility: University Hospital of Frankfurt, Medical Dept. II

location_facility: Hospital Universitario Virgen del Rocío (Sevilla)

location_facility: Hospital Universitario Germans Trias i Pujol (ICO - Badalona)


title: Study of Tumor Characteristics, Patient Care and Prognosis of Women With Breast Cancer During a Pregnancy Diagnosed Between 2000 and 2014

summary: This is a non-interventional, retrospective, multicentre study involving women having had a breast cancer during their pregnancy, diagnosed between 2000 and 2014 (cases) and non-pregnant women having had a breast cancer between 2000 and 2009 (controls).

time_perspective: Retrospective

location_facility: CHRU La Peyronie et Centre Val d'Aurelle

location_facility: Centre Hospitalier Départemental de Vendée

location_facility: Hôpital Bretonneau - Centre régional de cancérologie Henry Kaplan


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

location_country:
Poland
Spain
Italy
Canada
United States
France
Germany

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

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

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Klinikum Rechts der Isar der Technischen Universität

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

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

location_facility: Urology Cancer Center and GU Research Network

location_facility: Hospital Clinic I Provincial de Barcelona

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

location_facility: Centre Hospitalier Régional et Universitaire - Hôpital

location_facility: Centre Hospitalier Universitaire, Institut Gustave Roussy

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Siteman Cancer Center, Washington University School of Medicine

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

location_facility: Fondazione IRCCS Policlinico San Matteo Pavia

location_facility: Montefiore Medical Center, Albert Einstein College of Medicine

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


title: A Retrospective Study to Characterize Patients With HER2-positive Metastatic or Locally Advanced Breast Cancer, Treated by Herceptin® as 1st Line-therapy and Without Progression for at Least 3 Years Followed by a 1-year Prospective Study for Patients Still Alive

summary: This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without progression for at least three years. Patients will be followed prospectively for one year.

time_perspective: Other

lead_sponsor: Hoffmann-La Roche

location_facility: Polyclinique de Blois; Chimiotherapie Ambulatoire

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: CH Dptal Les Oudairies; Hematologie Oncologie

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: HOP Prive Arras Les Bonnettes; Chimiotherapie

location_facility: Hopital Emile Muller; Oncologie Radiotherapie

location_facility: Clinique Des 4 Pavillons; Chimiotherapie

location_facility: Chp Saint Gregoire; Cancerologie Radiotherapie

location_facility: Clinique sainte marie; chimiotherapie ambulatoire

location_facility: Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Clinique De L Europe; Radiotherapie Chimiotherapie

location_facility: Hopital Des Diaconesses; Hopital De Jour

location_facility: C.H. Du Pays D'aix En Provence Service du Dr Blanc

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0

location_facility: Chevelle Christian; Centre De Radiotherapie

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Ch Pitie Salpetriere; Oncologie Medicale

location_facility: Centre Hospitalier Uni Ire Caremeau; Radiotherapie & Oncologie

location_facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Clinique Champeau Mediterranee; Radiotherapie Oncologie

location_facility: Hopital Europeen La Roseraie;Radiotherapie

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Polyclinique Du Val De Saone; Chimiotherapie

location_facility: Hopital Augustin Morvan; Hopital De Jour

location_facility: Ch De Longjumeau; Hopital De Jour Et Semaine

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Clinique Saint Hilaire; Sce Chimiotherapie

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Hopital Edouard Herriot; Pavillon F Rhumatologie

location_facility: Pole Sante Republique;Oncologie Hematologie

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Polyclinique Kenval ; Radiotherapie Oncologie

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Ch Lyon Sud; Onco Secteur Jules Courmont

location_facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

location_facility: Polyclinique De Courlancy; Chimiotherapie Ambulatoire

location_facility: Polyclinique Sainte Marguerite; Chimiotherapie

location_facility: Centre Azureen De Cancerologie; Cons externes

location_facility: Polyclinique Du Beaujolais; Chimiotherapie


title: Evaluation of Factors Influencing Use of RoActemra® as Monotherapy in Rheumatoid Arthritis Patients in a Real Life Setting - ACT SOLO

acronym: ACT SOLO

summary: This prospective, multi-center, observational study will evaluate factors influencing the use of tocilizumab (RoActemra/Actemra) as monotherapy in rheumatoid arthritis patients in real life setting. Data will be collected from participants for 12 months following initiation of tocilizumab treatment.

ReferenceCitation: Flipo RM, Maillefert JF, Chazerain P, Idier I, Coudert M, Tebib J. Factors influencing the use of tocilizumab as monotherapy in patients with rheumatoid arthritis in a real-life setting: results at 1 year of the ACT-SOLO study. RMD Open. 2017 Jan 10;3(1):e000340. doi: 10.1136/rmdopen-2016-000340. eCollection 2017.


title: An Ambispective, Non Interventional Study of 2 Cohorts (Triple Negative or HR+) of Patients With HER2- Metastatic or Locally Advanced Breast Cancer Treated With Avastin® (Bevacizumab) 1st Line for at Least 12 Months and Without Progression for at Least 12 Months.

summary: This observational study will evaluate the safety and efficacy of triple negative or HR+ patients with HER2-metastatic or locally advanced breast cancer treated with Avastin (bevacizumab) as first line therapy for at least 12 months and without disease progression for at least 12 months. Data will be collected retrospectively (from the diagnosis to the inclusion in the study) and for 18 months from study start.