acronym: JUNIPER

summary: This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 [NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.

location_facility: Digestive Care Associates, A Medical Corporation

location_facility: Irkutsk State Medical Academy of Continuing Education

location_facility: Riga East Clinical University Hospital, clinic "Gailezers"; Department of Endoscopy

location_facility: University of Texas Southwestern Medical Center; Internal Medicne

location_facility: Clinical Hospital Center Sestre Milosrdnice

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

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

location_facility: Vidant Medical Group, LLC DBA Vidant Multispeciality Clinic-Kinston

location_facility: Nottingham University Hospitals Queen's Medical Centre

location_facility: Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner

location_facility: Gastroenterology Associates of Central Georgia

location_facility: Hacettepe University Medical Faculty; Gastroenterology

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: University of California San Diego Medical Center

location_facility: Gastroenterology Associates of Western Michigan, P.L.C.

location_facility: McGuire Research Institute; Gastroenterology

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

location_facility: Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics

location_facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

location_facility: Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri

location_facility: Charlotte Gastroenterology and Hepatology, P.L.L.C

location_facility: Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie

location_facility: University of North Carolina at Chapel Hill

location_facility: Charité Campus Virchow-Klinikum; Department of Cardiology

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: Hospital do Servidor Público Estadual/HSPE-SP

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: University Hospital - London Health Sciences Centre

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ

location_facility: Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Universidade Federal de Sao Paulo - UNIFES

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

location_facility: Digestive Disease Institute; Virginia Mason Medical Center

location_facility: University of Florida College of Medicine

location_facility: Kocaeli Universitesi Tip Fakultesi; Infectious Diseases

location_facility: Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie

location_facility: Vilnius University Hospital Santariskiu Clinics, Public Inst; Department of Clinical Pharmacology

location_facility: Amsterdam UMC, Locatie VUMC; Gastroenterology

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: CHA Bundang Medical Centre; CHA university

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN

location_facility: Medeniyet University Goztepe Training and Research Hospital.

location_facility: Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2

location_facility: Seoul National University Bundang Hospital

location_facility: Winnipeg Regional Health Authority; Neurosurgery Department

location_facility: Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

location_facility: CI of Kyiv RC Regional Clinical Hospital #2

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Federal State Military Educational Inst. of High Prof. Edu Military Medical Acad; Therapy department

location_facility: CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine

location_facility: Innovative Medical Research of South Florida

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Acibadem Kozyatagi Hospital; Gastroenterology

location_facility: Asst Fatebenefratelli Sacco (Fatebenefratelli)

location_facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

location_facility: Leids Universitair Medisch Centrum; Cardiology

location_facility: SBEI HPE Altai StateMedicalUniversityofMoH andSD

location_facility: RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU

location_facility: McGill University Health Centre - Glen Site

location_facility: Zespó Przychodni Specjalistycznych PRIMA

location_facility: Hospital Clínic i Provincial; Servicio de Farmacia

location_facility: Tel Aviv Sourasky Medical Center; Pharmacy

location_facility: Szt Janos Korhaz es EbudaiEgyesitettKorhazak

location_facility: LEC at SBIH of Moscow "City Clinical Hospital # 24"; Gastroenterology

location_facility: North-Western Medical University n.a. I.I. Mechnikov; Rheumatology

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

location_facility: Debreceni Egyetem Klinikai Központ; B?rgyógyászati Klinika

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

location_facility: Yonsei University Wonju Severance Christian Hospital

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

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika

location_facility: Medical Center of Limited Liability Company Medical Clinic Blagomed

location_facility: ULB Hopital Erasme; Service de Néphrologie

location_facility: Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Private Small Enterprise Medical Center Pulse

location_facility: University of Mississippi Medical Center

location_facility: Policlinico Universitario Agostino Gemelli; Farmacia

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology

location_facility: Northwestern Uni-Feinberg School of Medicine

location_facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

location_facility: Haydarpasa Numune Training and Research Hospital; Gastroenterology

location_facility: SBEIHPE Novosibirsk State Medical University

title: An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144


type: Registry Identifier

type: EudraCT Number

title: A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis

summary: The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Dulai PS, Feagan BG, Sands BE, Chen J, Lasch K, Lirio RA. Prognostic Value of Fecal Calprotectin to Inform Treat-to-Target Monitoring in Ulcerative Colitis. Clin Gastroenterol Hepatol. 2023 Feb;21(2):456-466.e7. doi: 10.1016/j.cgh.2022.07.027. Epub 2022 Aug 4.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, Danese S, Rogers R, Bornstein JD, Chen J, Schreiber S, Sands BE, Lirio RA. Histologic Outcomes With Vedolizumab Versus Adalimumab in Ulcerative Colitis: Results From An Efficacy and Safety Study of Vedolizumab Intravenous Compared to Adalimumab Subcutaneous in Participants With Ulcerative Colitis (VARSITY). Gastroenterology. 2021 Oct;161(4):1156-1167.e3. doi: 10.1053/j.gastro.2021.06.015. Epub 2021 Jun 16.

ReferenceCitation: Sands BE, Peyrin-Biroulet L, Loftus EV Jr, Danese S, Colombel JF, Toruner M, Jonaitis L, Abhyankar B, Chen J, Rogers R, Lirio RA, Bornstein JD, Schreiber S; VARSITY Study Group. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1215-1226. doi: 10.1056/NEJMoa1905725.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

version: acceptedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ipd_sharing: Yes

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

lead_sponsor: Takeda

location_country:
Germany
Poland
Argentina
Australia
Bosnia and Herzegovina
Turkey
Croatia
Czechia
Canada
Serbia
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
United States
Latvia
Ukraine
Romania
Belgium
Estonia
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy

location_facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

location_facility: Toronto Digestive Disease Associates, Inc.

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

location_facility: Onze Lieve Vrouwe Gasthuis, Locatie Oost

location_facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

location_facility: Gastroenterology Associates of Western Michigan, P.L.C.

location_facility: Texas Digestive Disease Consultants - Irving

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

location_facility: Centro de Investigacion Farmacologica del Bajio, S.C.

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Hospital da Senhora da Oliveira Guimaraes

location_facility: CI City Clinical Hospital #6 Dept of Gastroenterology

location_facility: University of North Carolina at Chapel Hill

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: SPb SBIH "City Hospital of Saint Martyr Elizaveta"

location_facility: Gastroenterology Associates of Tidewater

location_facility: MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

location_facility: Ars-Medica S.C Rybak Maria, Rybak Zbigniew

location_facility: S.C Centrul de Gastroenterologie Dr. Goldis S.R.L

location_facility: Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU

location_facility: Ohio State University Clinical Trials Management Office

location_facility: The Catholic University of Korea, Seoul St. Marys Hospital

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU

location_facility: Pauls Stradins Clinical University Hospital SLLC

location_facility: SBEI HPE "Kazan State Medical University" of the MoH of the RF

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Gastroenterology Consultants of South Texas, PA

location_facility: Markhot Ferenc Oktatokorhaz es Rendelointezet

location_facility: Kocaeli Derince Training and Research Hospital

location_facility: Alegent Creighton Clinic Gastroenterology

location_facility: Centro Hospitalar e Universitario de Coimbra E.P.E

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

location_facility: Fundacion Oftalmologica de Santander - FOSCAL

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

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

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: Medical University of South Carolina (MUSC)

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

location_facility: Marmara University Pendik Research and Training Hospital

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

location_facility: FSMEI HPE Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia

location_facility: CI A.and O. Tropiny City Clinical Hospital

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Vilnius University Hospital Santariskiu Clinic, Public Institution

location_facility: Gastroenterology Research of San Antonio, LLC

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

location_facility: Centro de Investigaciones Clinicas Instituto del Corazon

location_facility: SBEI of HPE "Omsk SMA" SBEI HPE "Omsk State Medical University" of the MoH of the RF

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel

location_facility: The Oregon Clinic-West Hills Gastroenterology

location_facility: Center for Digestive Health and Nutritional Excellence

location_facility: Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: EuroMediCare Szpital Specjalistyczny z Przychodni we Wroclawiu

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont

location_facility: Clinical Hospital Center "Sestre Milosrdnice"

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Long Island Clinical Research Associates

location_facility: Gastroenterology Associates of Central Georgia

location_facility: Centralny Szpital Kliniczny MSW w Warszawie

location_facility: Seconda Universita degli Studi di Napoli

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

location_facility: Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus

location_facility: Groupe Hospitalier Sud - Hopital Haut-Leveque

location_facility: Universitair Medisch Centrum Groningen (UMCG)

location_facility: McMaster University Health Sciences Center

location_facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

location_facility: Klaipeda Republican Hospital, Public Institution

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Instituto de Investigaciones Clinicas-Mar del Plata

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: FSBIH "Central Clinical Hospital of Russian Academy of Sciences"

location_facility: SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU

location_facility: Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE

location_facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia

location_facility: Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU

location_facility: SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM

location_facility: Klaipeda University Hospital, Public Institution

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Medical Research Center of Connecticut, LLC

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

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: SBIH of Yaroslavl region " Regional Clinical Hospital "

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: Expertia S.A- Mautalen Salud e Investigacion

location_facility: FSBI State Scientific Centre of Coloproctology" of the MoH of RF

location_facility: FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Hospital General Universitario de Alicante

location_facility: Centro Hospitalar do Alto Minho - Unidade Local de Saude do Alto Minho, EPE

location_facility: Seoul National University Bundang Hospital

location_facility: Haydarpasa Numune Training and Research Hospital

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

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU

location_facility: RSBIH "Smolensk Regional Clinical Hospital"

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: CI of Kyiv RC Kyiv Regional Clinical Hospital

location_facility: California Medical Research Associates Inc.

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


acronym: HICKORY

lead_sponsor: Hoffmann-La Roche

summary: This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.

ReferenceCitation: Peyrin-Biroulet L, Hart A, Bossuyt P, Long M, Allez M, Juillerat P, Armuzzi A, Loftus EV Jr, Ostad-Saffari E, Scalori A, Oh YS, Tole S, Chai A, Pulley J, Lacey S, Sandborn WJ; HICKORY Study Group. Etrolizumab as induction and maintenance therapy for ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors (HICKORY): a phase 3, randomised, controlled trial. Lancet Gastroenterol Hepatol. 2022 Feb;7(2):128-140. doi: 10.1016/S2468-1253(21)00298-3. Epub 2021 Nov 17.

oa_host_type: repository

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

unpaywall_oa_status: green

ReferenceCitation: Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

license: cc-by

license_normalized: cc-by

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

location_facility: Gastroenterology Center of the Midsouth, P.C.

location_facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

location_facility: Nottingham University Hospitals; QMC Campus

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: CHU Amiens - Hopital Sud; Pharmacie - Secteur des Essais cliniques

location_facility: Hôpital Nord - CHU Marseille; Gastroenterology and Hepatology

location_facility: Fakultni nemocnice Brno; Interni kardiologicka klinika

location_facility: Clinical Applications Laboratories, Inc.

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: Inselspital-Universitaetsspital Bern; Institut fuer Spitalpharmazie

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo

location_facility: Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner

location_facility: Gastroenterology Associates of Central Georgia

location_facility: Hadassah University Hospital - Ein Kerem; Neurosurgery

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: University of California San Diego Medical Center

location_facility: McGuire Research Institute; Gastroenterology

location_facility: Centro Regiomontano de Estudios Clínicos Roma S.C.

location_facility: Cliniques Universitaires Saint-Luc; Nephrology

location_facility: Hamburgisches Forschungsinstitut fuer CED

location_facility: University of North Carolina at Chapel Hill

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: University of Calgary; Heritage Medical Research Clinic

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ

location_facility: Klinikum Klagenfurt am Wörtersee; Acute geriatric care

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Kyungpook National University Hospital; Opthalmology

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

location_facility: Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN

location_facility: Ålborg Universitets Hospital; Gastromedicinsk

location_facility: Markhot Ferenc Oktato Korhaz es Rendelointezet

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

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: Vilnius University Hospital Santariskiu Clinic Public Insti

location_facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

location_facility: CAEP - Centro Avancado de Estudos e Pesquisas Ltda.

location_facility: Digestive and Liver Disease Specialists, Ltd.

location_facility: EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

location_facility: Launceston General Hospital; Gastroenterology Research

location_facility: University of Michigan; Michigan Institute for Clinical and Health Research (MICHR)

location_facility: Ospedale di Circolo; Neuropsichiatria Infantile

location_facility: University of California at San Francisco

location_facility: Universitätsklinikum Freiburg; Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation

location_facility: Massachusetts General Hospital; Crohn's & Colitis Center

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: Fundacion Hospital de Alcorcon; Servicio de Digestivo

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

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology

location_facility: Rigshospitalet; Medicinsk gastroenterologisk klinik

location_facility: Anticancer Hospital of Thessaliniki " Theagenio"

location_facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

location_facility: Rabin Medical Center-Beilinson Campus; Gaucher Clinic, Genetics Institute

title: Phase III, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors

source: euctr

location_country:
Germany
Poland
Argentina
Australia
Brazil
Czechia
Canada
France
Lithuania
Hungary
Denmark
Switzerland
United States
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Israel


title: Phase IIIB, International, Single Group, Open Study to Define an Optimal Monitoring of IGF-1 in Children Treated With NutropinAq, Using a Novel Capillary Blood Collection Method

acronym: OPTIMA

summary: The main purpose of this study is to establish an optimal monitoring regimen in NutropinAq treated children, using newly developed capillary blood spot IGF-1 measurement technology.

lead_sponsor: Ipsen

location_country:
Finland
Germany
Italy
Slovakia
United Kingdom
Denmark
Romania
Belgium
Spain
Greece
Czechia
Ukraine
Russian Federation
France

location_facility: Tushino Pediatric Hospital, RMAPE Department of Endocrinology for Childhood and Adolescent Age

location_facility: Centre Pédiatrique Gatien de Clocheville

location_facility: Endocrinology Research Centre RAMS, Institute of Pediatric Endocrinology

location_facility: Ukrainian Scientific practical Centre of Endocrine surgery, Endocrine Organs and Tissues Transplantation

location_facility: Clinica Pediatrica, Universita Federico II di Napoli

location_facility: Scientific-Research Institute of Endocrinology, Academy of Medical Science of Ukraine

location_facility: Azienda Policlinico - Università di Catania

location_facility: Institutul de Endocrinologie C.I. Parhon


title: A Phase 1 First in Human, Multicenter, Open-Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics, and RP2D of ABBV-184 in Subjects With Previously Treated Cancers

summary:
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. This study focuses on two types of cancers: Acute Myeloid Leukemia (AML) and Non-Small Cell Lung Cancer (NSCLC). AML (blood cancer) is cancer of the white blood cells (WBC). NSCLC (solid tumor) is a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine recommended phase 2 dose (RP2D) and to see if the study drug is safe and able to treat patients who have AML and NSCLC.

ABBV-184 is an investigational drug being developed for treatment of cancer. The study has two arms and two phases: AML arm and NSCLC arm; dose escalation and dose expansion phase. Adult participants with diagnosis of AML or NSCLC will be enrolled. In dose escalation phase, around 36 participants will be enrolled in each arm. In dose expansion phase, around 20 participants will be enrolled in each arm. The study will be conducted in approximately 50 sites across 10 countries.

Participants will receive weight based intravenous (IV) infusion of ABBV-184 once a week. At the beginning of the study, visits will occur daily during hospitalization followed by less frequently over time.

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

status: Terminated

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: AbbVie

location_country:
France
United Kingdom
Japan
United States
Israel

location_facility: Centre Antoine Lacassagne - Nice /ID# 218014

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 215703

location_facility: The Chaim Sheba Medical Center /ID# 215810

location_facility: Gabrail Cancer Center Research /ID# 215667

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 217252

location_facility: Aichi Cancer Center Hospital /ID# 216469

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 224998

location_facility: Cardiff & Vale University Health Board /ID# 217250

location_facility: Tel Aviv Sourasky Medical Center /ID# 222749

location_facility: Fort Wayne Medical Oncology and Hematology, Inc /ID# 224332

location_facility: National Cancer Center Hospital East /ID# 216467

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 217508

location_facility: National Cancer Center Hospital /ID# 216466

status_simplified: Unknown


title: An Open-label, Multi-centre Study to Evaluate the Long-term Safety and Tolerability of REN001 in Subjects With Primary Mitochondrial Myopathy (PMM)

summary: This study is designed to evaluate the long-term safety and tolerability of REN001 administered once daily to subjects with PMM due to mitochondrial DNA mutations (mtDNA-PMM) or nuclear DNA mutations (nDNA-PMM). Subjects with mtDNA mutations will have previously completed Study REN001-201 or participated in Study REN001-101. Subjects with nDNA mutations who enroll in this study will be REN001- naïve.

status: Enrolling by invitation

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Reneo Pharma Ltd

location_country:
Germany
Italy
New Zealand
Hungary
United Kingdom
Denmark
Australia
Netherlands
Belgium
Spain
Canada
France

location_facility: U.O. di Neurologia - Neurofisiopatologia

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Queen Square Centre for Neuromuscular Diseases

location_facility: Medical Center of the University of Munich Friedrich Baur Institute at the Neurological Clinic and Polyclinic

location_facility: Hôpitaux Universitaires Pitié Salpêtrière

location_facility: University Hospital Bonn Clinic and Polyclinic for Neurology

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Neurophysiopathology Unit

location_facility: CHU de Strasbourg- Hopital de Hautepierre

location_facility: IRCCS Institute of Neurological Sciences of Bologna

location_facility: Centre de Référence des Maladies Neuromusculaires

location_facility: A.O.U Policlinico di Messina U.O.C Neurologia e Malattie Neuromuscolari

location_facility: Semmelweis University Insitute of Genomics and Rare Disorders

location_facility: M.A.G.I.C. Clinic (Metabolics and Genetics in Calgary)

location_facility: Centre for Brain Research Neurogenetic Clinic

location_facility: Istituto Nazionale Neurologico Carlo Besta

location_facility: Hospital Universitari i Politècnic La Fe


type: Other Identifier

title: TALAPRO-3: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, STUDY OF TALAZOPARIB WITH ENZALUTAMIDE VERSUS PLACEBO WITH ENZALUTAMIDE IN MEN WITH DDR GENE MUTATED METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

summary: The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.

status: Active, not recruiting

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

sponsor_collaborators:
Pfizer
Astellas Pharma Inc

location_country:
Finland
Germany
Argentina
Australia
Japan
Turkey
Czechia
Canada
France
Slovakia
Hungary
United States
Ukraine
India
Belgium
China
Italy
Norway
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation

location_facility: SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"

location_facility: Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"

location_facility: Centre of Applied Urology Research, Nova Scotia Health Authority

location_facility: Multiprofile Hospital for Active Treatment - Uni Hospital OOD

location_facility: Centro de Investigaciones Clínicas - Clínica Viedma

location_facility: Texas Oncology-Deke Slayton Cancer Center

location_facility: Hirosaki University School of Medicine & Hospital

location_facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet

location_facility: AZ (Algemeen Ziekenhuis) Maria Middelares

location_facility: BHI of Omsk region "Clinical Oncological Dispensary"

location_facility: Istanbul University, Cerrahpasa Faculty of Medicine

location_facility: Fundación Instituto Valenciano de Oncología

location_facility: Huntsman Cancer Institute - University of Utah

location_facility: Vychodoslovensky onkologicky ustav, a.s.

location_facility: Royal Devon and Exeter NHS Foundation Trust

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Chonnam National University Hwasun Hospital

location_facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hospital Universitario Central de Asturias

location_facility: Comm Noncommerc Entp Lviv Reg Council "Lviv Oncological Regional Therapeutical and Diagnostic Cntre

location_facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD

location_facility: AdventHealth Medical Group Hematology and Oncology

location_facility: Hopitaux Universitaires de Strasbourg - ICANS (Institut de Cancerologie Strasbourg Europe)

location_facility: Centro de Investigacion Pergamino SA - Clinica Pergamino SA

location_facility: Althaia, Xarxa Assistencial Universitària de Manresa

location_facility: Gallipoli Medical Research Foundation, Greenslopes Private Hospital

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Medical & diagnostic center of LISOD-Israeli Oncological Hosp "MedX-ray International Group"

location_facility: Communal Non-Profit Enterprise "Regional Center of Oncology"

location_facility: Municipal Ent "Dnipropetrovsk Regional Clinical Hosp (I.I.Mechnikov Dnipropetrovsk Regional council)

location_facility: Holston Valley Hospital and Medical Center

location_facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD

location_facility: SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan

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

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Netaji Subhas Chandra Bose Cancer Hospital

location_facility: Providence Oncology and Hematology Care Clinic - Westside

location_facility: Federal State Budgetary Institution "Russian Research Center of Roentgenology and Radiology" of t

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: University Health Network-Princess Margaret Cancer Centre

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Mid-Illinois Hematology & Oncology Associates, Ltd

location_facility: The Second Hospital of Tianjin Medical University

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

location_facility: Urology San Antonio, PA dba USA Clinical Trials

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: MRRC n.a. A.F. Tsyb - branch of FSBI "NMRC of Radiology" Minzdrav Russia

location_facility: Sahyadri Clinical Research & Development Centre

location_facility: Complex Oncology Center - Stara Zagora Ltd.

location_facility: Bhaktivedanta Hospital and Research Institute

location_facility: Bhakti Vedanta Hospital and Research Institute

location_facility: Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi

location_facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Istituto Romagnolo per lo Studio dei Tum.ori "Dino Amadori" (IRST)

location_facility: Limited Liability Company "4D Ultrasound Clinic" (LLC "4D Ultrasound Clinic")

location_facility: Federal State Budgetary Institution "Central Clinical Hospital with ambulance"

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

location_facility: Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"

location_facility: Providence Cancer Institute Franz Clinic

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Investigational Drug Services, Advent Health Orlando

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: IRCCS Istituto Tumori "Giovanni Paolo II" di Bari

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: The Third Xiangya Hospital of Central South University

location_facility: Instituto Veracruzano en Investigación Clínica S.C.

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte

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

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Centro di Riferimento Oncologico di Aviano (CRO) IRCCS

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli

location_facility: Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet

location_facility: Institut fuer Diagnostische und Interventionelle Radiologie

location_facility: Fondazione Casa Sollievo della Sofferenza

location_facility: Instituto Médico Especializado Alexander Fleming

location_facility: State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"

location_facility: West China Hospital of Sichuan University

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Regional Budgetary Healthcare Institution "Ivanovskiy Regional Oncology Dispensary" (RBHI "IvROD")

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center

location_facility: Branch of the Limited Liability Company "Hadassah Medical Ltd."

location_facility: Nanfang Hospital of Southern Medical University

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

location_facility: West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Providence Cancer Institute Clackamas Clinic

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: The First Affiliated Hospital Chongqing Medical University

location_facility: Independent medical-diagnostic laboratory "Medisken" EOOD

location_facility: Municipal Non-Commercial Enterprise of Kharkiv Regional Council Regional Medical Clinical Center of

location_facility: Rajiv Gandhi Cancer Institute and Research Centre

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: CHUM - Centre Hospitalier de l'Université de Montréal

location_facility: Sandton Oncology Medical Group (Pty) Ltd

location_facility: Gujarat Hospital - Gastro and Vascular Centre

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Clinical Research Unit, University of Pretoria

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

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

location_facility: Providence Cancer Institute Newberg Clinic

location_facility: Private Medical Institution "Euromedservice"

location_facility: MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department

location_facility: Seoul National University Bundang Hospital

location_facility: Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica

location_facility: Washington Cancer Institute at MedStar Washington Hospital Center

location_facility: Adana City Training and Research Hospital

status_simplified: Ongoing


title: Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6

summary:
The interferon- and ribavirin- (RBV) free combination regimen of glecaprevir plus pibrentasvir (GLE/PIB) for the treatment of genotypes 1 to 6 of chronic hepatitis C (CHC) viral infection has been shown to be safe and effective in randomized controlled clinical trials.

This observational study is an effectiveness research examining the regimen of GLE/PIB, used according to local label, under real world conditions in a clinical practice patient population.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Aghemo A, Horsmans Y, Bourgeois S, Bondin M, Gschwantler M, Hofer H, Semmo N, Negro F, Zhang Z, Marcinak J, Veitsman E, Hazzan R, Mimidis K, Goulis I, Marques N, Flisiak R, Mazur W, Roncero C, Marra F, Pageaux GP, Asselah T, Lampertico P. Real-World Outcomes in Historically Underserved Patients with Chronic Hepatitis C Infection Treated with Glecaprevir/Pibrentasvir. Infect Dis Ther. 2021 Dec;10(4):2203-2222. doi: 10.1007/s40121-021-00455-1. Epub 2021 Jun 14. Erratum In: Infect Dis Ther. 2021 Sep 16;:

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: University of Bern - Bern Open Repository and Information System

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

version: submittedVersion

unpaywall_oa_status: gold

ReferenceCitation: Mullhaupt B, Semela D, Ruckstuhl L, Magenta L, Clerc O, Torgler R, Negro F, Semmo N. Real-world effectiveness and safety of glecaprevir/pibrentasvir therapy in patients with chronic hepatitis C virus infection in Switzerland. Swiss Med Wkly. 2021 Jan 19;151:w20399. doi: 10.4414/smw.2021.20399. eCollection 2021 Jan 18.

oa_colors: green diamond

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Zurich - Zurich Open Repository and Archive

publisher_dissemination: SMW Supporting Association

ipd_sharing: Undecided

location_country: France Italy Poland Portugal Switzerland Austria Belgium Greece Israel

location_facility: Centre Hospitalier de Béziers /ID# 202948

location_facility: Azienda Ospedaliero - Universi /ID# 168130

location_facility: Centro Hospitalar Vila Nova Gaia/Espinho, EPE /ID# 208195

location_facility: Hopitaux Universitaires de Geneve /ID# 203435

location_facility: Hopital de la Cavale Blanche /ID# 202640

location_facility: Wojewodzki Szpit Bieganskiego /ID# 209608

location_facility: Centre Hospitalier PERPIGNAN /ID# 205762

location_facility: Papageorgiou General Hospital Thessaloniki /ID# 207980

location_facility: Inselspital, Universitaetsklinik /ID# 201022

location_facility: Azienda Ospedaliera di Rilievo /ID# 168141

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206414

location_facility: Hopital Bichat-Claude Bernard /ID# 202513

location_facility: Centre Hospitalier de Wallonie Picarde /ID# 200822

location_facility: AOU di Cagliari - Presidio di /ID# 168132

location_facility: KH der Elisabethinen Linz GmbH /ID# 169915

location_facility: Centre Hosp Intercommunal de Creteil /ID# 202566

location_facility: NZOZ Przychodnia Specjalistycz /ID# 208334

location_facility: Szpital Specjalistyczny W Chorzowie /Id# 209129

location_facility: CH Annecy Genevois Site Annecy /ID# 202804

location_facility: CHU NANCY - Hopital Brabois Adultes /ID# 202570

location_facility: Universita degli Studi della /ID# 168135

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 168712

location_facility: Centro Hospitalar Barreiro Montijo, EPE /ID# 211267

location_facility: Tzaneio general hospital of Piraeus /ID# 208828

location_facility: Azienda Ospedaliera Maggiore d /ID# 168710

location_facility: Hospital Garcia de Orta, E.P.E /ID# 207717

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 168711

location_facility: Universitair Ziekenhuis Leuven /ID# 170921

location_facility: A.O.U. Policlinico G. Martino /ID# 168139

location_facility: Klinikum Wels - Grieskirchen /ID# 169916

location_facility: AOU Citta della Salute Scienza /ID# 168142

location_facility: General Oncological Hospital of Kifisia Oi Agioi Anargyroi /ID# 206419

location_facility: CHR Orleans - Hopital de la Source /ID# 202360

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 168137

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 207910

location_facility: Algemeen Stedelijk Ziekenhuis /ID# 170876

location_facility: Azienda Ospedaliera Luigi Sacc /ID# 168136

location_facility: Gastroenterology Institute, Division of Medicine /ID# 169360

location_facility: Wilhelminenspital der Stadt Wien /ID# 169914

location_facility: Centro Hospitalar Universitário Lisboa Central, EPE - Hospital Curry Cabral /ID# 208463

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II /ID# 208451

location_facility: Wojewodzki Szpit Bieganskiego /ID# 208445

location_facility: Ctre Hospitalier de Tourcoing /ID# 202358

location_facility: Ctre Hospitalier de Tourcoing /ID# 202805

location_facility: AOU OO. RR. San Giovanni di Di /ID# 168715

location_facility: CHU de Besancon - Jean Minjoz /ID# 208502

location_facility: Centro Hospitalar do Porto EPE /ID# 207733

location_facility: Azienda Ospedaliera di Padova /ID# 168126

location_facility: Wojewódzki Szpital Zespolony w Kielcach /ID# 210569

location_facility: University Hospital St. Polten /ID# 169918

location_facility: General Hospital Nikaias-Piraeus St. Panteleimon /ID# 206420

location_facility: Klinikum Klagenfurt am Woerthersee, Apotheke /ID# 169931

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 208604

location_facility: Assaf Harofeh Medical Center /ID# 169370

location_facility: NZOZ - Lubuska Specjalistyczna Poradnia Chorób Wątroby Sp. z o.o. /ID# 208449

location_facility: Wojewodzki Szpital Obserwacyjn /ID# 209345

location_facility: MED-FIX Centrum Medyczne Sp. z /ID# 208453

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 168138

location_facility: Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 202957

location_facility: Ospedale Sant Orsola Malpighi /ID# 168127

location_facility: Azienda Ospedaliera Luigi Sacc /ID# 168140

location_facility: IBD Center - IRCCS Istituto Clinico Humanitas /ID# 169353

location_facility: Azienda Universitaria Ospedali /ID# 168129

location_facility: Cabinet Medical, Dr. Constant, /ID# 202361

location_facility: Fondazione Epatocentro Ticino /ID# 201024

location_facility: Cabinet Medical, Boyer Darrigr /ID# 202050

location_facility: Medizinische Universität Graz /ID# 169932

location_facility: Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 170930

location_facility: Specjalistyczny Szpital im. dra Alfreda Sokolowskiego /ID# 208862

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 168709

location_facility: Azienda Ospedaliera di Padova /ID# 168125

location_facility: Università Cattolica Sacro Cuore /ID# 168781

location_facility: General Hospital of Athens Laiko /ID# 206421

location_facility: Gen Univ Hosp Alexandroupolis /ID# 206416


title: Global PANORAMA Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in Patients With Locally Advanced or Metastatic NSCLC.

acronym: PANORAMA

summary:
This is an observational cohort study of patients with locally advanced or metastatic NSCLC (non-small cell lung cancer).

Patients will be recruited from participating sites in Europe, Asia, and Canada. The study will include 2 patient cohorts.

lead_sponsor: AstraZeneca

location_country:
United Kingdom
China
Spain
Taiwan
Canada
France

intervention_type: Other


title: A Registry for Subjects With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection

summary: The primary objective of this registry study is to assess the durability of sustained virologic response (SVR) and clinical progression or regression of liver disease including the incidence of hepatocellular carcinoma following SVR in participants with cirrhosis after treatment with a sofosbuvir-based regimen for HCV infection.

ReferenceType: background

ReferenceCitation: Dunn W, Koestler D, Ni L, Kersey K, Kreter B, Hammond K et al. Cirrhosis regression based on both Enhanced Liver Fibrosis (ELF) and Fibrotest after Direct-acting Hepatitis C therapeutics corresponds to a lower incidence rate of hepatocellular carcinoma below the cost-effective threshold for surveillance [Poster 1289]. The International Liver Congress™ EASL - European Association for the Study of the Liver (EASL); 2021 23-26 June.

ReferenceCitation: Fan R, Papatheodoridis G, Sun J, Innes H, Toyoda H, Xie Q, Mo S, Sypsa V, Guha IN, Kumada T, Niu J, Dalekos G, Yasuda S, Barnes E, Lian J, Suri V, Idilman R, Barclay ST, Dou X, Berg T, Hayes PC, Flaherty JF, Zhou Y, Zhang Z, Buti M, Hutchinson SJ, Guo Y, Calleja JL, Lin L, Zhao L, Chen Y, Janssen HLA, Zhu C, Shi L, Tang X, Gaggar A, Wei L, Jia J, Irving WL, Johnson PJ, Lampertico P, Hou J. aMAP risk score predicts hepatocellular carcinoma development in patients with chronic hepatitis. J Hepatol. 2020 Dec;73(6):1368-1378. doi: 10.1016/j.jhep.2020.07.025. Epub 2020 Jul 21.

ReferenceCitation: Jacobson I, Muir AJ, Lawitz EJ, Gane E, Conway B, Ruane PJ, et al. Course of Cirrhosis Regression: Lessons From Patients With HCV Cirrhosis Following Successful Sofosbuvir-Based Treatment [Poster 537]. AASLD: The Liver Meeting® 2019, November 11-15.

ReferenceCitation: Mangia A, Lawitz E, Gane E Conway B, Ruane PJ, Abergel A, et al. Long-Term Follow-up of Patients with Chronic HCV Infection and Compensated or Decompensated Cirrhosis Following Treatment with Sofosbuvir-Based Regimens. The International Liver Congress™ EASL - European Association for the Study of the Liver (EASL); 2018 April 11-15.

ReferenceCitation: Muir AJ, Buti M, Nahass R, Agarwal K, Gane EJ, Strasser SI, et al. Long-term Follow-up of Patients With Chronic HCV Infection and Compensated or Decompensated Cirrhosis Following Treatment With Sofosbuvir-Based Regimens [Poster 880]. AASLD: The Liver Meeting® 2019, November 11-15.

ReferenceCitation: Reddy KR, Bourlière M, Agarwal K, Lawitz E, Osinusi A, Kersey K, et al. Sustained Viral Response Following Treatment With Direct-Acting Antiviral Agents for Chronic Hepatitis C and the Risk of Hepatocellular Carcinoma [Poster FRI-185]. The International Liver Congress™ EASL - European Association for the Study of the Liver (EASL); 2017 19-23 April.

ReferenceCitation: Reddy R, Muir A, Naggie S, Lawitz E, Gane E, Conway B et al. Noninvasive Tests of Fibrosis and Risk of Liver-Related Complications: Lessons From Patients With HCV Cirrhosis Following Successful Sofosbuvir-Based Treatment [Poster 452]. The International Liver Congress™ EASL - European Association for the Study of the Liver (EASL); 2020 27-29 August.

ReferenceCitation: Reddy R, Muir A, Naggie S, Lawitz E, Gane E, Conway B et al. Non-invasive tests of fibrosis and risk of liver-related complications: observations following successful sofosbuvir-based treatment in patients with HCV cirrhosis. J Hepatology 2020;73: S401-S652.

ReferenceCitation: Younossi ZM, Racila A, Muir A, Bourliere M, Mangia A, Esteban R, Zeuzem S, Colombo M, Manns M, Papatheodoridis GV, Buti M, Chokkalingam A, Gaggar A, Nader F, Younossi I, Henry L, Stepanova M. Long-term Patient-Centered Outcomes in Cirrhotic Patients With Chronic Hepatitis C After Achieving Sustained Virologic Response. Clin Gastroenterol Hepatol. 2022 Feb;20(2):438-446. doi: 10.1016/j.cgh.2021.01.026. Epub 2021 Jan 22.

oa_host_type: publisher

evidence: open (via free pdf)

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/

lead_sponsor: Gilead Sciences

location_country:
Germany
Italy
New Zealand
United Kingdom
Australia
United States
Spain
Canada
Puerto Rico
France

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

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Binghamton Gastroenterology Associates, PC

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: University of Pennsylvania Health System

location_facility: Nashville Gastrointestinal Specialists, Inc.

location_facility: Vancouver Infectious Disease Research and Care Centre

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Ospedale Casa Sollievo Della Sofferenza IRCCS

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: Asheville Gastroenterology Associates, PA

location_facility: Bon Secours St. Mary's Hospital of Richmond

location_facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda

location_facility: University of Miami Miller School of Medicine

location_facility: South Florida Center of Gastroenterology

location_facility: University of California, Davis Medical Center

location_facility: Klinikum der Johann Wolfgang Goethe Universitat

location_facility: Community Research Initiative of New England

location_facility: Gastroenterology Center of the MidSouth, P.C.

location_facility: University of California at San Francisco Medical Center

location_facility: London Health Sciences Centre - University Campus

location_facility: The North Texas Clinical Research Institute

location_facility: Nottingham University Hospitals NHS Trust


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

acronym: Bridalveil

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

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

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

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Australia
Sweden
United States
Korea, Republic of
Spain
Taiwan
Czechia
Canada
Russian Federation
France

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Universitari i Politecnic La Fé de Valencia

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda

location_facility: Kaiser Permanente Vallejo Medical Center

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

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Gemeinschaftspraxis Dres. Söling Und Siehl

location_facility: Centre Hospitalier Affilie Universitaire de Quebec

location_facility: University College London Hospitals National Health Society Foundation Trust

location_facility: Centre Hospitalier Départmental La Roche sur Yon

location_facility: Froedtert Hospital and Medical College of Wisconsin

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Centralny Szpital Kliniczny MSW w Warszawie

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

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

location_facility: Queen Elizabeth II Health Sciences Centre, Centre for Clinical Research

location_facility: Hadassah Medical Organization, Ein Kerem

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

location_facility: Centre Hospitalier Universitaire de Strasbourg - Hôpital Hautepierre

location_facility: Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku

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

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi

location_facility: Comprehensive Blood and Cancer Center (Bakersfield)

location_facility: Hospital Clínico Universitario de Salamanca

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

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino

location_facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

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

location_facility: North Shore Hematology/Oncology Associates

location_facility: Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte

location_facility: Guys and Saint Thomas NHS Foundation Trust

location_facility: Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto

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

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Joliet Oncology Hematology Associates Ltd.

location_facility: FGU Russian Scientific Research Institute of Hematology and Transfusiology

location_facility: Szpital Kliniczny nr 1, Katedra i Klinika Hematoonkologii i Transplantacji Szpiku

location_facility: Haematology and Oncology Clinics of Australia Gold Coast

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: Sylvester Comprehensive Cancer Center/UMHC

location_facility: N. N. Blokhin Russian Cancer Research Center

location_facility: Spedali Civili Di Brescia Azienda Ospedaliera

location_facility: Klinikum der Ludwig-Maximilians-Universität München

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau


title: A Phase 3, Multi-Site, Open-Label Study Of The Long Term Safety And Tolerability Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

summary: The main objective of this study is to evaluate the long-term safety of CP-690,550 in patients being treated for moderate to severe chronic plaque psoriasis. This is an open label extension study available to patients who participated in one of the qualifying studies with CP-690,550 providing entry criteria is met.

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

repository_institution: Newcastle Univesity - Newcastle University ePrints

repositories_concat: PubMed Central;eprint.ncl.ac.uk

repositories_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Valenzuela F, Korman NJ, Bissonnette R, Bakos N, Tsai TF, Harper MK, Ports WC, Tan H, Tallman A, Valdez H, Gardner AC. Tofacitinib in patients with moderate-to-severe chronic plaque psoriasis: long-term safety and efficacy in an open-label extension study. Br J Dermatol. 2018 Oct;179(4):853-862. doi: 10.1111/bjd.16798. Epub 2018 Aug 13.

publisher_dissemination: Oxford University Press

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

http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Bosnia and Herzegovina
Croatia
Chile
Czechia
Canada
Serbia
France
Colombia
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
Belgium
Puerto Rico
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Sweden

location_facility: Szabolcs-Szatmar-Bereg Megyei Korjazak es Egyetemi Okatokorhaz, Borgyogyaszati Szakrendeles

location_facility: CENIT Centro de Neurociencias Investigacion y Tratamiento

location_facility: LKH Salzburg, Landesklinik fuer Dermatologie

location_facility: University of Pittsburgh Medical Center - Department of Dermatology

location_facility: University hospital center "Sestre milosrdnice" clinic for dermatology and venerology disease

location_facility: Dermatovenerologic dispensary #10 of Vyborg region

location_facility: University Dermatology Clinic "Andreas Syggros" Hospital

location_facility: Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center

location_facility: New York University (NYU) School of Medicine - Investigational Pharmacy (IP Shipment, Pharmacy)

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Hopital de Brabois / Batiment Philippe Canton

location_facility: State Research Center of Dermatovenerology

location_facility: University of North Carolina at Chapel Hill

location_facility: Office of Dr. Paul Adam (back-up location)

location_facility: Saint Louis University - Department of Dermatology

location_facility: Chang Gung Medical Foundation Linkou Branch

location_facility: Deaconess Clinic Downtown Research Institute

location_facility: Yonsei University College of Medicine, Severance Hospital

location_facility: Klinika Dermatologii, Wenerologii i Alergologii Uniwersyteckiego Centrum Klinicznego

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR

location_facility: Facharzt fuer Dermatologie und Allergologie

location_facility: NorthShore University Health System - Division of Dermatology

location_facility: Michigan Center for Research Corporation dba Michigan Center for Skin Care Research

location_facility: Regional Municipal Dermatovenerologic Dispensary

location_facility: UMHAT "Dr. Georgi Stranski" - II clinical base

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Tolna Megyei Balassa Janos Korhaz, Borgyogyaszati Osztaly

location_facility: Dr. Tuppal's Privat Practice, Oshawa Clinic

location_facility: Dept of Dermatology and Venerology of SI "Crimean State Medical University n.a. S.I.Georgiyevskyy"

location_facility: Kyiv Oleksandrivska Clin. Hosp., Dermatology department, NMU n.a. O.O. Bogomolets,

location_facility: Centre de Recherche Dermatologique du Québec Métropolitain

location_facility: University Hospitals Case Medical Center

location_facility: Hospital da Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Vas Megyei Markusovszky Korhaz/Borgyogyaszati Osztaly

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: SI 'Institute for Dermatology and Venerology of AMS of Ukraine'

location_facility: Leavitt Medical Associates of Florida dba Ameriderm Research

location_facility: Bispebjerg Hospital, University of Copenhagen

location_facility: University of North Carolina at Chapel Hill- Hospital

location_facility: Katedra i Klinika Chorob Skornych i Wenerycznych, Pomorski Uniwersytet Medyczny

location_facility: International Dermatology Research, Inc.

location_facility: Tsentar za kozhno venericheski zaboliavania EOOD

location_facility: Rivergate Dermatology Clinical Research Center, PLLC

location_facility: Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum

location_facility: Centro Internacional de Estudios Clinicos, CIEC

location_facility: University Hospitals Case Medical Center/Dept. of Dermatology

location_facility: Specjalistyczne Gabinety Lekarskie "Dermed"

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Klinikai Kutatasi Osztaly

location_facility: Rostov-on-Don regional dermatovenerologic dispensary

location_facility: Massachusetts General Hospital - Clinical Unit for Research Trials and Outcomes in Skin

location_facility: Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem AOK Oktato Korhaza, Borgyogyaszati Osztaly

location_facility: Centro De Investigaciones Dermatologicas

location_facility: Klinik and Poliklinik fur Dermatologie and Allergologie der Universitaet Bonn

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Luebeck

location_facility: Centrum Badan Klinicznych s.c. Wieslawa Porawska, Lukasz Porawski

location_facility: Hopital Larrey Departement de Dermatologie

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Oddelenie biologickej liecby, Narodny ustav reumatickych chorob

location_facility: Debreceni Egyetem Klinikai Kozpont, Borgyogyaszati Klinika

location_facility: Krajska zdravotni a.s.,Masarykovy nemocnice o.z.

location_facility: Pecsi Tudomanyegyetem Aok Bor- Nemikortani Es Onkodermatologiai Klinika

location_facility: Instituto Dermatologico De Jalisco "Dr Jose Barba Rubio"

location_facility: Spolka Cywilna Andrzej Krolicki, Tomasz Kochanowski "Laser Clinic"

location_facility: Centro Integral de Reumatologia del Caribe Cicaribe S.A.S

location_facility: State Research Center of Dermatovenerology,

location_facility: IP ONLY: University Hospitals Case Medical Center

location_facility: MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow"

location_facility: Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu

location_facility: Clinical hospital of emergency care N.V. Soloviev

location_facility: Bakersfield Dermatology and Skin Cancer Medical Group

location_facility: Dermatovenerologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

location_facility: Dr. Zohair Tomi PMC Inc. Paton Medical Centre

location_facility: Novum Instytut Dermatologii Leczniczej i Estetycznej

location_facility: Baker Allergy Asthma and Dermatology Research Center, LLC

location_facility: The Guenther Dermatology Research Centre

location_facility: CRCMRGilbert Inc., Centre de Dermatologie Maizerets

location_facility: North-Western State Medical University I.I. Mechnikov

location_facility: DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.

location_facility: Klinikum der Johann Wolfgang Goethe Universitaet

location_facility: Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter

location_facility: Chang Gung Medical Foundation Kaohsiung Branch

location_facility: University General Hospital of Ioannina / Dermatology and Venereology Department

location_facility: Tampere Univeristy Hospital, Department of Dermatology and Venereology

location_facility: Nemocnice Ceske Budejovice, a.s. Ustavni lekarna

location_facility: Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz, Borgyogyaszati Osztaly

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: UMBAL-Alexandrovska- Sofia Klinika po dermatologia i venerologia

location_facility: Mexico Centre for Clinical Research S.A. de C.V.

location_facility: Grupo Dermatologico De Carolina (Office of Dr. Alma Cruz MD)

location_facility: Dept of Dermatology and Venerology of Lugansk State Medical University,

location_facility: Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa

location_facility: Ternopil Regional Municipal Clinical Dermatovenerologic Dispensary

location_facility: Dres. Kirsten Prepeneit und Volker Streit

location_facility: Atlanta Dermatology, Vein & Research Center, P.C.

location_facility: Ryazan regional clinical dermatovenerologic dispensary

location_facility: Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie

location_facility: The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)

location_facility: NYU Langone Medical Center, Ambulatory Care Center, Department of Dermatology, Clinical Studies Unit

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Eastern Canada Cutaneous Research Associates Ltd.

location_facility: Centennial Center-Comprehensive Clinical Research

location_facility: Veszprem Megyei Csolnoky Ferenc Korhaz Borgyogyaszat

location_facility: Colegio Mayor de Nuestra Señora del Rosario

location_facility: Hospital General Universitario de Alicante

location_facility: Instituto de Dermatologia e Estetica do Brasil LTDA - IDERJ

location_facility: Taipei Medical University-Shuang Ho Hospital

location_facility: Hautarztpraxis Dres. Scholz, Sebastian, Schilling

location_facility: "Papageorgiou" General Hospital/B' Dermatology and Venereology Clinic of University of Thessaloniki

location_facility: CHU Limoges - Hôpital Dupuytren - Pharmacie

location_facility: Dept of Dermatology and Venerology of ONMU

location_facility: North Florida Dermatology Associates, PA

location_facility: Klinik und Poliklinik fur Dermatologie und Allergologie der Universitaet Bonn

location_facility: SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika

location_facility: Hud kliniken- Skanes Universitetssjukhus i Malmo


title: A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma

summary: The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

status: Recruiting

ipd_sharing_description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

lead_sponsor: Bristol-Myers Squibb

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Chile
Czechia
Canada
France
Colombia
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Sweden
Austria
Mexico
Spain
Israel

location_facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

location_facility: Intermountain Medical Center Campus Location

location_facility: Oncology Hematology West P.C. dba Nebraska Cancer Specialist

location_facility: Stanford Univ Med School Dept of Dermatology

location_facility: UPCO - Hospital de Clinicas de Porto Alegre

location_facility: Maria Sklodowska-Curie National Research Institute of Oncology

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka

location_facility: Hospital General Universitario de Valencia

location_facility: Department of Dermatology, University Hospital St. Poelten

location_facility: Hosptial Sao Lucas da PUC de Porto Alegre

location_facility: Dignity Health - St. Josephs Hospital and Medical Center

location_facility: Greenebaum Cancer Center University of Maryland

location_facility: Fondazione IRCCS Istituto Nazionale Dei Tumori

location_facility: INCA- Instituto Nacional de Cancer Jose de Alencar Gomes da Silva

location_facility: University of Sydney - Melanoma Institute Australia MIA

location_facility: Bradford Hill Centro de Investigacion Clnica

location_facility: Ft. Wayne Medical Oncology and Hematology

location_facility: The Angeles Clinic and Research Institute

location_facility: Istituto Nazionale Tumori - Fondazione Pascale Italy

location_facility: Universitatsklinik fur Dermatologie der Paracelsus medizinischen Privatuniversitat Salzburg

location_facility: Medizinische Universitaet WienAKH, Dpt. of Dermatology


title: A Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-risk Melanoma

summary:
The primary objective of the study is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by relapse free survival (RFS)

The secondary objectives of the study are:

To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by overall survival (OS)
To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by melanoma specific survival (MSS)
To evaluate whether post-operative adjuvant therapy improves distant metastasis-free survival (DMFS), in stage IIC or III patients receiving fianlimab + cemiplimab compared to pembrolizumab
To assess impact of fianlimab + cemiplimab on quality of life as compared to pembrolizumab in adults
To assess safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab
To characterize pharmacokinetics (PK) of fianlimab + cemiplimab using sparse PK sampling in patients 12 years of age and older
To assess immunogenicity of fianlimab and against cemiplimab

ipd_sharing_description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Turkey
Chile
Czechia
Canada
France
United States
Romania
Belgium
Italy
United Kingdom
Mexico
Spain
Greece
South Africa
Georgia
Israel

location_facility: Iatriko Diavalkaniko Thessaloniki, Pharmacy

location_facility: Klinikum der Stadt Ludwigshafen am Rhein

location_facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka w Slupsku

location_facility: JSC K. Eristavi National Center of Experimental and Clinical Surgery

location_facility: Farmacia Ospedaliera, Fondazione Policlinico Universitario Agostini Gemeli IRCCS

location_facility: Hospital Universitario Vall d'Hebron, Edificio General-Planta Baja, UITM, Unidad de Farmacia de Ensa

location_facility: Hospital General Universitario Gregorio Maranon (HGUGM)

location_facility: Institul Oncologic Prof. Dr Ion Chiricuta

location_facility: University Health Network, Princess Margaret Cancer Centre

location_facility: The Pharmacy Department, Musgrove Park Hospital, Somerset Foundation Trust

location_facility: High Technology Medical Center, University Clinic Tbilisi

location_facility: Arcispedale SantAnna UOC Farmacia Ospedaliera Ufficio sperimentazioni cliniche, SETTORE 2B1 Presidi

location_facility: Animi Unidade de Tratamento Oncologico Ltda

location_facility: University Hospitals Cleveland Medical Center

location_facility: John Wayne Cancer Institute - Saint John's Health Center

location_facility: Sainte Catherine Institut du Cancer Avignon Provence

location_facility: Israeli Georgian medical research clinic Helsicore

location_facility: Farmacia Ospedaliera, Instituto Europeo di Oncologia

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di Bari

location_facility: Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii

location_facility: Area dassajos clinics/Medicaments en investigacio, Servei de Farmacia Hospital Clinic de Barcelona (ICMHO)

location_facility: The University of Texas Southwestern Medical Center

location_facility: Hopital Saint Louis - APHP, Service de Pharmacie - Niveau

location_facility: Clinical Trials Unit Bristol Haematology & Oncology Centre

location_facility: Royal Devon University Healthcare NHS Foundation Trust, Clinical Trials Pharmacy

location_facility: Calvary North Adelaid Hospital (HPS Pharmacies)

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carita, Farmacia Ospedaliera

location_facility: LTD Cancer Center of Adjara Autonomic Republic

location_facility: VITAZ vzw - pharm Sara Van Opdenbosch t.a.v. apotheek

location_facility: LTD Research Institute of Clinical Medicine (LLC Todua Clinic)

location_facility: Ospedale S.Chiara - APSS di Trento - Magazzino Farmacia

location_facility: ONCOSITE - CENTRO DE PESQUISA CLINICA EM ONCOLOGIA LTDA Setor Farmacia Pesquisa Clini

location_facility: Universidad Mayor - Centro Oncologia de Precision (PROFAR)

location_facility: DIABAID - Instituto de Asistencia Integral en Diabetes

location_facility: Trakya Universitesi, Balkan Onkoloji Hastanesi Linik Arastirmar Odasi

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: Liverpool Hospital (Cancer Therapy Pharmacy)

location_facility: Hospital Universitario Quiron Dexeus Barcelona

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Sao Vicente de Paulo - Instituto do Cancer

location_facility: Hospital Clinico Universitario de Valencia

location_facility: CHU HENRI MONDOR Pharmacie Secteur ESSAIS CLINIQUES

location_facility: CHU de DIJON - Pharmacie Essais Cliniques

location_facility: Izmir Katip Celebi University Ataturk training and Research Hospital

location_facility: Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss)

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: Instituto Nazionale Tumori IRCCS Fondazione G. Pascale

location_facility: CH Le Mans - CCS Pharmacie-essais cliniques, aile B

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A de C.V

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Associacao Hospitalar Moinhos de Vento, Centro de Pesquisa Clinica

location_facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital

location_facility: Andrew Love Cancer Centre, University Hospital Geelong

location_facility: Instituto Joinvilense de Hematologia e Oncologia

location_facility: Fundacion CENIT para la investigacion en Neurociencias

location_facility: Virginia Cancer Specialist Research Institute

location_facility: Fondazione Policlinico Campus Bio-Medico

location_facility: Instituto de Ensino e Pesquisas Sao Lucas - IEP HEMOMED