title: Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)

acronym: PROMINENT

summary:
The primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of:

nonfatal Myocardial Infarction (MI)
nonfatal ischemic stroke
coronary revascularization; or
Cardio Vascular (CV) death.

ReferenceCitation: Das Pradhan A, Glynn RJ, Fruchart JC, MacFadyen JG, Zaharris ES, Everett BM, Campbell SE, Oshima R, Amarenco P, Blom DJ, Brinton EA, Eckel RH, Elam MB, Felicio JS, Ginsberg HN, Goudev A, Ishibashi S, Joseph J, Kodama T, Koenig W, Leiter LA, Lorenzatti AJ, Mankovsky B, Marx N, Nordestgaard BG, Páll D, Ray KK, Santos RD, Soran H, Susekov A, Tendera M, Yokote K, Paynter NP, Buring JE, Libby P, Ridker PM; PROMINENT Investigators. Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk. N Engl J Med. 2022 Nov 5. doi: 10.1056/NEJMoa2210645. [Epub ahead of print]

ReferenceCitation: Pradhan AD, Paynter NP, Everett BM, Glynn RJ, Amarenco P, Elam M, Ginsberg H, Hiatt WR, Ishibashi S, Koenig W, Nordestgaard BG, Fruchart JC, Libby P, Ridker PM. Rationale and design of the Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes (PROMINENT) study. Am Heart J. 2018 Dec;206:80-93. doi: 10.1016/j.ahj.2018.09.011. Epub 2018 Sep 29. Review.

lead_sponsor: Kowa Research Institute, Inc.

location_country:
Spain
United Kingdom
Ukraine
United States
Romania
Japan
South Africa
Czechia
Poland
Russian Federation
Argentina
Puerto Rico
India
Israel
Mexico
Slovakia
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
France
Colombia
Netherlands

location_facility: SI National Scientific Centre of Radiation Medicine of NAMSU

location_facility: OhioHealth Heart & Vascular Physicians (Heartcare, Inc.) - Athens

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

location_facility: Acibadem City Clinic Tokuda Hospital Ead

location_facility: Neurologische Praxis Dr. Schoell & Kollegen

location_facility: Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut

location_facility: FSBI "Scientific-research Institute for Complex Problems of cardiovascular disease"

location_facility: Kernodle Clinic, Inc., Dept. of the Private Diagnostic Clinic, PLLC

location_facility: Central Arkansas Veterans Healthcare System

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Instituto de Investigaciones Clinicas San Nicolas

location_facility: Centro de Investigacion Clinica del Pacifico, S.A. de C.V.

location_facility: Delmarva Heart Research Foundation, Inc.

location_facility: ZKS-Südbrandenburg -center for clinical studies Südbrandenburg GmbH

location_facility: Santa Rosa Cardiology Medical Group, Inc.

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

location_facility: Community Hospital of Anderson and Madison County, Inc.

location_facility: Novant Health - Heart and Vascular Institute

location_facility: Fundación Centro de Investigaciones Biomédicas Riescard

location_facility: NZOZ Przychodnia Specjalistyczna H. Rudzki, A. Wittek

location_facility: Cardiovascular Research of Northwest Indiana, LLC

location_facility: Transcarpathian Regional Clinical Cardiology Dispansery

location_facility: Centro de Investigacion Cardiovascular y Metabolica

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

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Kardiologicka ambulance MUDr. Ferkl s.r.o.

location_facility: Yaroslavl Regional Clinical Hospital of War Veterans

location_facility: SBEI HPE "Moscow State Medical and Dentistry University n.a. A. I. Evdokimov" of the MoH of the RF

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

location_facility: ISPEM - Instituto São José dos Campos em Pesquisas Médicas

location_facility: Diabetes and Thyroid Center of Fort Worth

location_facility: SAIH "Kemerovo Regional Clinical Hospital"

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft.- Gyula DRS

location_facility: SBIH of Moscow "City Clinical Hospital n.a.Bakhrushinykh"

location_facility: Nemocnica s poliklinikou sv. Barbory Roznava a.s.

location_facility: Dr. Uwe Böckmann / Birgit Jacobs - Diabeteszentrum Neumünster

location_facility: State Budgetary Healthcare Institution Clinical Medical Sani

location_facility: SI V.P.Komisarenko Institute of E&M of NAMSU

location_facility: Synexus Polska Sp. z o.o. Oddział we Wroclawiu

location_facility: Nakakinen Clinic Medical Corporation Kensei-kai

location_facility: IMC - Instituto de Moléstias Cardiovasculares Tatuí

location_facility: University of North Texas Health Science Center

location_facility: Research Institute of the Carolinas, PLC

location_facility: LLC Treatment and Diagnostic Center Adonis Plus

location_facility: Nuevas tecnologías en Diabetes y Endocrinología

location_facility: Murmansk Regional Clinical Hospital named after Bayandin

location_facility: MC Doctor Alex Dept of General Practice-Family Medicine Kharkiv MA of PGE

location_facility: Fortis Flight Lieutenant Rajan Dhall Hospital

location_facility: CNE City Clin Hosp #8 of KCC Dept of Therapy Kharkiv MA of PGE of MOHU

location_facility: National Center For Geriatrics And Gerontology

location_facility: AMH Feasterville Family Health Care Center

location_facility: S.C. Diabmed Dr. Popescu Alexandrina S.R.L

location_facility: SEIHPE "Ural SMA of RosZdrav" b.o. LLC "City Hospital #41"

location_facility: Hospital Interzonal General de Agudos Dr Jose Penna

location_facility: IPCC - Instituto de Pesquisa Clínica de Campinas

location_facility: Providence Veteran Administration Medical Center

location_facility: Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Okinawa Tokushukai Chubu Tokushukai Hospital

location_facility: CMI Dr. Stolea T. Violeta - Medic specialist diabet zaharat, nutritie si boli metabolice

location_facility: Gemeinschaftspraxis fuer innere Medizin und Diabetologie

location_facility: SBIH of Novosibirsk Region "Clinical Emergency Hospital #2"

location_facility: King Edward Memorial Hospital Research Centre

location_facility: Synexus Merseyside Clinical Research Centre

location_facility: GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

location_facility: Diagnostic Consultative Center II - Sofia OOD

location_facility: Schnitzler Cardiovascular Consultants (SCC), PLLC

location_facility: CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU Med Inst

location_facility: LMC Clinical Research dba Manna Research Inc. Toronto

location_facility: NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie

location_facility: Synexus Helderberg Clinical Research Centre

location_facility: MC of Subsidiary Production Unit Med Scient Pract Union Medbud of PJSc Holding Company Kyivmiskbud

location_facility: TSHI "Altay Territorial Cardiologocal dispensary"

location_facility: Iwate Medical University Uchimaru Medical Center Hospital

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Med Center of Eurolab LLC Policlinic Outpatient Dept O.O.Bogomolets NMU

location_facility: Clinique Médicale St-Louis (Recherche) inc d/b/a/ Centre de Recherche Saint-Louis

location_facility: Centro Cardiovascular Aristides Sotomayor Santa Lucia S.A.S. - IPS ASTALUC S.A.S. IPS

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

location_facility: Synexus Scotland Clinical Research Centre

location_facility: NSIH "Departmental Hospital on Station Kemerovo of OJSC "Russian Railways"

location_facility: K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre

location_facility: Lviv Reg St Clin Treatment - Diagnostic Endocrin Center, Dept of Polyclinic, D.Galytskyy Lviv NMU

location_facility: SIH "Saratov City Clinical Hospital # 2 n.a. V.I. Razumovskiy"

location_facility: Katholisches Krankenhaus "St. Johann Nepomuk"

location_facility: State Institution LT Malaya Inst. of Ther. of AMS of Ukraine

location_facility: CI of Kyiv RC Regional Clinical Hospital #2

location_facility: Maestri e Kormann Consultoria Medico Científica LTDA

location_facility: AA MRC LLC Ahmed Arif Medical Research Center

location_facility: TSBIH "Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich

location_facility: Zhytomyr regional clinical hospital n.a. O.F. Gerbachevskyy

location_facility: SI NSC M.D. Strazhesko Institute of Cardiology of NAMSU

location_facility: Hospital Privado Centro Medico de Cordoba S.A

location_facility: Department of Medical Services and Rehabilitation of State Joint Stock Holding Company Artem

location_facility: Poradnia Kardiologiczna Jarosław Jurowiecki

location_facility: Saint-Petersburg SBHI "City outpatient clinic #28"

location_facility: Saul Vizel Professional Medicine Corporation

location_facility: Clinical Investigation Specialists, Inc.

location_facility: National Cerebral and Cardiovascular Center

location_facility: Regional CH Dept of Endocrinology SHEI Ivano-Frankivsk NMU

location_facility: Jacksonville Center for Clinical Research

location_facility: L2IP - Instituto de Pesquisas Clínicas Ltda.

location_facility: Chattanooga Research and Medicine (CHARM)

location_facility: SHI "Perm Regional Hospital of War Veterans"

location_facility: RCI Chernivtsi Regional Endocrinology Center Policlinic Dept SHEI of UBSMU

location_facility: Eurolatino Natal Pesquisas Médicas Ltda.

location_facility: Institute of Medical Sciences and SUM Hospital

location_facility: Phoenix Veterans Adminstration Health Care System

location_facility: Centro de Atención e Investigación en Factores de Riesgo Cardiovascular Omega S.C.

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii lek. med. Krzysztof Cymerman

location_facility: Ryubokai Higashi Diabetes and Cardiovascular Clinic

location_facility: NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog.

location_facility: Synexus Polska sp. z o.o. Oddzial w Poznaniu

location_facility: HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

location_facility: Spitalul Clinic de Urgenta "Sfantul Pantelimon"

location_facility: Kalispell Regional Medical Center dba Glacier View Research Institute

location_facility: Center of Reconstructive & Restorative Medicine (University Clinic) of Odessa National Medical Uni

location_facility: MUDr. Jan KVASNICKA CSc. Angiologie kardiologie a interna

location_facility: Shri B. D. Mehta Mahavir Heart Institute

location_facility: CHI Kharkiv City Student Hosp Therap dept Nat Pharm Univer

location_facility: Synexus SA Watermeyer Clinical Research Centre

location_facility: BC Diabetes As Operated by Dr. TG Elliott, Inc.

location_facility: Houston Methodist Research Institute - CCAT Pearland

location_facility: CI Dnipropetrovsk City Cl Hosp #9 of Dniprop Reg Council SI DMA of MOH of Ukr Ch of Endocrinology

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

location_facility: Centro de Pesquisa Médica Santa Maria Ltda.

location_facility: SBIH of Novosibirsk region "City Clinical Hospital # 19"

location_facility: Diagnostic Consultation Center CONVEX EOOD

location_facility: Morgan Medical Management & Consultants Inc.

location_facility: Investigacion En Salud Y Metabolismo S.C.

location_facility: GP Dr. Haggenmiller, PD Dr. Michael Jeserich

location_facility: Miyanosawa Clinic of Internal Medicine and Cardiology

location_facility: Specjalistyczna Poradnia Kardiologiczna i Nadciśnienia Tętniczego

location_facility: Synexus Polska Sp. z o.o. Oddział w Warszawie

location_facility: Fakultna nemocnica s poliklinikou Nove Zamky

location_facility: CI Ye.Ye.Karabelesh Kherson City Clinical Hosp.

location_facility: SBHI "City Polyclinic #2 of Healthcare department of city of Moscow"

location_facility: CI Zapor CCH#10 SI ZMA PGE Ch of therapy clin pharmacol & endocrin

location_facility: Gemeinschaftspraxis Diabeteszentrum Dortmund Dr.med. Klaus Busch

location_facility: Texas Health Research & Education Institute

location_facility: Stratton Veterans Affairs Medical Center - Albany

location_facility: Tokushukai Kishiwada Tokushukai Hospital

location_facility: Public Central Hospital of Matto Ishikawa

location_facility: Southern New Hampshire Diabetes and Endocrinology

location_facility: Alta Pharmaceutical Research Center, Inc.

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

location_facility: CI Ivano-Frankivsk Reg Cl Card Center Dept of Chronic Ischemic Heart Dis SHEI Ivano-Frank NMU

location_facility: SBIH of Arkhangelsk region " First City Clinical hospital n.a. E. E. Volosevich"

location_facility: FSBI North-West Federal Medical Research Center n.a. V.A. Almazov of MoH RF

location_facility: CEMEDIC - Centro de Especialidades Medicas

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Ternopil City Municipal Hospital #2 Dept of Gastroenterology Ternopil I.Ya. Gorbachevskyi SMU

location_facility: Ivano-Frankivsk CCH Dept of Therapy #1 SHEI Ivano-Frankivsk NMU

location_facility: SBIH of Perm territory " City Clinical Hospital # 2 n.a. Fedor Khristoforovich Gral"

location_facility: Clinique des maladies Lipidiques de Quebec

location_facility: Royal Alexandra Hospital, CK Hui Heart Centre

location_facility: Clínica de Endocrinologia e Metabologia Ltda.

location_facility: University of Maryland School of Medicine

location_facility: FSBI "Research Institute for Cardiology" of Siberian Branch RAMS

location_facility: Louis Stokes Cleveland Dept of VA Medical Center

location_facility: Institut fuer klinische Forschung und Entwicklung Berlin GmbH

location_facility: Centro de Pesquisa Clínica Maimônides - Maimônides Day Hospital

location_facility: Iowa Diabetes and Endocrinology Research Center, PLC

location_facility: NZOZ Osrodek Kardiologii Inwazyjnej -Ikardia

location_facility: Hometown Urgent Care & Occupational Health

location_facility: Spitalul Clinic Judetean de Urgenta "Pius Brinzeu"

location_facility: Shiga University of Medical Science Hospital

location_facility: FSBSI "Scientific Research Institute of Therapy and Preventive Medicine"

location_facility: CMI CCH#3 Dep of Ther# w the beds of card profile HSEI of UBSMU

location_facility: Clínica Paulista de Doenças Cardiovasculares Ltda.

location_facility: Toyukai Yutenji Medical Clinic (Yutenji Naika)

location_facility: FSHI "MSU of MoIA of RF of Kemerovo Region"

location_facility: Institute of Cardiovascular Diseases Madras Medical Mission

location_facility: University Diabetes & Endocrine Consultants

location_facility: Sukromna interna a kardiologicka ambulancia

location_facility: CEDIC Centro de Investigaciones Clinicas

location_facility: Health Pharma Professional Research S.A. de C.V.

location_facility: BIH of Omsk region "Clinical Medico-Sanitary Unit # 9

location_facility: LMC Clinical Research dba Manna Research Inc. Burlington North

location_facility: Belgyogyaszati es Kardiologiai Maganrendelo

location_facility: HUJBB-UFPA - Hospital Universitário João de Barros Barreto - Universidade Federal do Pará

location_facility: KARDIOMED Janczska Kociwska Ostki PodckaRekrzSp

location_facility: Zentrum fuer Praevention und Rehabilitation

location_facility: Vinnytsia RC Highly Special.Endocr.Center Dept of Therapy #2 M.I. Pyrogov NMU

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

location_facility: FSBI "Central Clinical Hospital with Polyclinic of the Department for Presidential Affairs of the RF

location_facility: Huntington Hospital - Research Department

location_facility: Cline Research Center (Leite PS Consultoria Medica LTDA)

location_facility: Synexus SA - Stanza Clinical Research Centre

location_facility: KCCC of Endocr Dept of General Endocrine Pathology O. O. Bogomolets NMU

location_facility: Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran

location_facility: Northeast Clinical Research of San Antonio

location_facility: MC of PHEI Institute of General Practice - Family Medicine

location_facility: Private Small Enterprise Medical Center Pulse

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz

location_facility: Instituto de Diabetes, Obesidad y Nutrición S.C.

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L

location_facility: Solano y Terront Servicios Médicos Ltda.

location_facility: Applied Medical Informatics Research Inc.

location_facility: Clinical Research Institute of Arizona, LLC

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska dr n. med. Agnieszka Karczmarczyk Specjalista Chorob

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: Supe Heart & Diabetes Hospital & Research Centre

location_facility: SPSK Nr 7 SUM w Katowicach Gornoslaskie CM im. prof. Leszka Gieca

location_facility: Synexus Lancashire Clinical Research Centre

location_facility: Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II

location_facility: National Pirogov Memorial Medical University

location_facility: Ahmedabad Bariatrics and Cosmetics Pvt Ltd.

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

location_facility: Santa Casa de Misericórdia de Porto Alegre

location_facility: LMC Clinical Research dba Manna Research Inc. Mirabel

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni

location_facility: CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

location_facility: SI V.P.Komisarenko Institute of Endocrinology and Metabolism of NAMSU

location_facility: VA Nebraska-Western Iowa Health Care System

location_facility: Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC

location_facility: Centro de Investigacion Medica de Occidente, S.C.

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP

location_facility: Joanne F. Liutkus Medicine Professional Corporation

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

location_facility: Synexus Manchester Clinical Research Centre

location_facility: CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Kardiologicka, interna a sonograficka amb. Kardio-Sanus, sro

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Z+P MED Egeszsegugyi, Kereskedelmi es Szolgaltato Bt.

location_facility: Railway Transport Kharkiv CH#1 of Healthcare Center Branch of PJSC Ukrainian Railway

location_facility: Centro de Investigacion Medico Asistencial S.A.S

location_facility: Inst. Privado de Inv. Clinicas de Cordoba

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Clearwater Cardiovascular & Interventional Consultants

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Lviv Communal 4th City Clinical Hospital

location_facility: Synexus Birmingham Clinical Research Centre

location_facility: Dr. Nagy Laszlo Kardiologiai Maganrendeles

location_facility: Nemocnica arm. generala L. Svobodu Svidnik, a.s.,

location_facility: Captain James A. Lovell Federal Health Care Center

location_facility: SPb SBIH "City Multy-field Hospital # 2"

location_facility: Veterans Affairs Ann Arbor Healthcare System

location_facility: CPCLIN - Centro de Pesquisas Clínicas Ltda.

location_facility: Centro de Investigacion Cardiometabolica de Aguascalientes S.A de C.V

location_facility: Railway Transport Kharkiv CH #1 of Healthcare Center Branch of PJSC Ukr Railway

location_facility: Hospital Regional Universitario de Malaga

location_facility: Medical Center of Limited Liability Company Medical Center Concilium Medical

location_facility: South Shore Internal Medicine Associates

location_facility: Kyiv CH on Railway Transport #2 of Branch Center of Healthcare Public Company Ukr Railway

location_facility: Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine

location_facility: Cincinnati Veterans Affairs Medical Center

location_facility: SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU

location_facility: Fundación Oftalmológica de Santander - FOSCAL

location_facility: CI Cherkasy RH of Cherkasy Regional Council

location_facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach

location_facility: Centro de Investigaciones Medicas Mar del Plata

location_facility: Centre de Dépistage et Recherche Cardiovasculaire Rive-Sud

location_facility: Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia

location_facility: Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu"

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares S.C.

location_facility: Albert Schweitzer Ziekenhuis, Zwijndrecht


type: EudraCT Number

title: Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

summary: This rollover study will provide open-label treatment with cenicriviroc and will assess the long-term safety of continued treatment with cenicriviroc in participants who participated in either the CENTAUR study 652-2-203 [NCT02217475] or the AURORA study [NCT03028740].

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Tobira Therapeutics, Inc.

location_country:
Poland
Hong Kong
Spain
Italy
United Kingdom
Australia
Puerto Rico
United States
France
Belgium
Germany

location_facility: AOU Policlinico Paolo Giaccone di Palermo

location_facility: University of Buffalo - Erie County Medical Center

location_facility: Johns Hopkins University School of Medicine

location_facility: Uniklinik Koeln, Poliklinik fuer Endokrinologie, Diabetologie und Praeventivmedizin (ZEDP)

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

location_facility: Digestive Health Specialists of the Southeast - Dothan

location_facility: Consultants for Clinical Research - Cincinnati

location_facility: Royal Brisbane Hospital and Women's Hospital

location_facility: Universitaetsklinikum Hamburg-Eppendorf - I. Medizinische Klinik und Poliklinik

location_facility: University of Miami - Schiff Center for Liver Diseases

location_facility: University of California, San Diego (UCSD) - Medical Center

location_facility: Hospital de la Santa Creu i Sant Pau Barcelona

location_facility: Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital

location_facility: Virginia Commonwealth University Medical College of Virginia

location_facility: Mercy Medical Center - Baltimore, Maryland

location_facility: Universitaetsklinikum Heidelberg - Innere Medizin IV

location_facility: University Hospital Giessen and Marburg GmbH

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.

location_facility: Charite - University Hospital Berlin - Campus Virchow - Hospital

location_facility: Central Adelaide Local Health Network Inc - Royal Adelaide Hospital

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

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: Predicting Acute-on-Chronic Liver Failure in Cirrhosis (PREDICT) Study

acronym: PREDICT

summary: The aim of this study is to assess prospectively the critical period prior to the development of Acute-on-Chronic Liver Failure (ACLF) (1), to uncover mechanistic and pathophysiological processes associated with the development and clinical course of ACLF (2) and to identify the precipitating events of ACLF (3).

status: Completed

study_type: Observational

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Trebicka J, Fernandez J, Papp M, Caraceni P, Laleman W, Gambino C, Giovo I, Uschner FE, Jansen C, Jimenez C, Mookerjee R, Gustot T, Albillos A, Bañares R, Jarcuska P, Steib C, Reiberger T, Acevedo J, Gatti P, Shawcross DL, Zeuzem S, Zipprich A, Piano S, Berg T, Bruns T, Danielsen KV, Coenraad M, Merli M, Stauber R, Zoller H, Ramos JP, Solé C, Soriano G, de Gottardi A, Gronbaek H, Saliba F, Trautwein C, Kani HT, Francque S, Ryder S, Nahon P, Romero-Gomez M, Van Vlierberghe H, Francoz C, Manns M, Garcia-Lopez E, Tufoni M, Amoros A, Pavesi M, Sanchez C, Praktiknjo M, Curto A, Pitarch C, Putignano A, Moreno E, Bernal W, Aguilar F, Clària J, Ponzo P, Vitalis Z, Zaccherini G, Balogh B, Gerbes A, Vargas V, Alessandria C, Bernardi M, Ginès P, Moreau R, Angeli P, Jalan R, Arroyo V; PREDICT STUDY group of the EASL-CLIF CONSORTIUM. PREDICT identifies precipitating events associated with the clinical course of acutely decompensated cirrhosis. J Hepatol. 2021 May;74(5):1097-1108. doi: 10.1016/j.jhep.2020.11.019. Epub 2020 Nov 20.

ReferenceCitation: Trebicka J, Fernandez J, Papp M, Caraceni P, Laleman W, Gambino C, Giovo I, Uschner FE, Jimenez C, Mookerjee R, Gustot T, Albillos A, Bañares R, Janicko M, Steib C, Reiberger T, Acevedo J, Gatti P, Bernal W, Zeuzem S, Zipprich A, Piano S, Berg T, Bruns T, Bendtsen F, Coenraad M, Merli M, Stauber R, Zoller H, Ramos JP, Solè C, Soriano G, de Gottardi A, Gronbaek H, Saliba F, Trautwein C, Özdogan OC, Francque S, Ryder S, Nahon P, Romero-Gomez M, Van Vlierberghe H, Francoz C, Manns M, Garcia E, Tufoni M, Amoros A, Pavesi M, Sanchez C, Curto A, Pitarch C, Putignano A, Moreno E, Shawcross D, Aguilar F, Clària J, Ponzo P, Jansen C, Vitalis Z, Zaccherini G, Balogh B, Vargas V, Montagnese S, Alessandria C, Bernardi M, Ginès P, Jalan R, Moreau R, Angeli P, Arroyo V; PREDICT STUDY group of the EASL-CLIF Consortium. The PREDICT study uncovers three clinical courses of acutely decompensated cirrhosis that have distinct pathophysiology. J Hepatol. 2020 Oct;73(4):842-854. doi: 10.1016/j.jhep.2020.06.013. Epub 2020 Jul 13.

ipd_sharing: No

lead_sponsor: Jonel Trebicka

location_country:
Denmark
Portugal
Spain
Italy
Austria
Netherlands
United Kingdom
Switzerland
Hungary
France
Turkey
Belgium
Germany
Slovakia

location_facility: Hospital Clinic y Provencial de Barcelona

location_facility: Derriford Hospital, Plymouth Hospitals Trust

location_facility: Pavol Jozef Sfarik University Kosice/Roosevelt Hospital Bystrica

intervention_type: Other

status_simplified: Completed


title: An Open-Label Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

source: euctr

location_country:
Poland
Romania
Spain
Russian Federation
Canada
Ukraine
Hungary
France
United States
Israel
Belgium
Germany
Czechia

location_facility:
Teva Investigational Site 14622
Teva Investigational Site 14628
Teva Investigational Site 14652
Teva Investigational Site 58292
Teva Investigational Site 37083
Teva Investigational Site 54150
Teva Investigational Site 52115
Teva Investigational Site 51282
Teva Investigational Site 51280
Teva Investigational Site 80131
Teva Investigational Site 58284
Teva Investigational Site 53408
Teva Investigational Site 58298
Teva Investigational Site 14624
Teva Investigational Site 58299
Teva Investigational Site 53402
Teva Investigational Site 14650
Teva Investigational Site 14630
Teva Investigational Site 80135
Teva Investigational Site 58283
Teva Investigational Site 51281
Teva Investigational Site 58287
Teva Investigational Site 11134
Teva Investigational Site 58297
Teva Investigational Site 14633
Teva Investigational Site 58289
Teva Investigational Site 14632
Teva Investigational Site 53401
Teva Investigational Site 14646
Teva Investigational Site 53405
Teva Investigational Site 50458
Teva Investigational Site 80132
Teva Investigational Site 14635
Teva Investigational Site 58288
Teva Investigational Site 58285
Teva Investigational Site 50455
Teva Investigational Site 14626
Teva Investigational Site 14621
Teva Investigational Site 51291
Teva Investigational Site 50454
Teva Investigational Site 50457
Teva Investigational Site 58295
Teva Investigational Site 51285
Teva Investigational Site 14648
Teva Investigational Site 14645
Teva Investigational Site 32680
Teva Investigational Site 50461
Teva Investigational Site 52113
Teva Investigational Site 32670
Teva Investigational Site 32681
Teva Investigational Site 58304
Teva Investigational Site 14644
Teva Investigational Site 32677
Teva Investigational Site 14649
Teva Investigational Site 51292
Teva Investigational Site 58302
Teva Investigational Site 53399
Teva Investigational Site 58303
Teva Investigational Site 14654
Teva Investigational Site 54149
Teva Investigational Site 14629
Teva Investigational Site 32673
Teva Investigational Site 14634
Teva Investigational Site 14623
Teva Investigational Site 80133
Teva Investigational Site 14638
Teva Investigational Site 54151
Teva Investigational Site 51284
Teva Investigational Site 53407
Teva Investigational Site 58286
Teva Investigational Site 54148
Teva Investigational Site 11133
Teva Investigational Site 58282
Teva Investigational Site 50456
Teva Investigational Site 53406
Teva Investigational Site 35229
Teva Investigational Site 31218
Teva Investigational Site 14640
Teva Investigational Site 50460
Teva Investigational Site 58301
Teva Investigational Site 32679
Teva Investigational Site 80136
Teva Investigational Site 31217
Teva Investigational Site 31219
Teva Investigational Site 58293
Teva Investigational Site 14655
Teva Investigational Site 37081
Teva Investigational Site 37082
Teva Investigational Site 14647
Teva Investigational Site 58294
Teva Investigational Site 32672
Teva Investigational Site 14653
Teva Investigational Site 32675
Teva Investigational Site 14631
Teva Investigational Site 14651
Teva Investigational Site 32676
Teva Investigational Site 14620
Teva Investigational Site 14619
Teva Investigational Site 14641
Teva Investigational Site 50453
Teva Investigational Site 80134
Teva Investigational Site 14643
Teva Investigational Site 58290
Teva Investigational Site 51293
Teva Investigational Site 32671
Teva Investigational Site 51286
Teva Investigational Site 80129
Teva Investigational Site 53404
Teva Investigational Site 58296
Teva Investigational Site 35228
Teva Investigational Site 32674
Teva Investigational Site 14639
Teva Investigational Site 58291
Teva Investigational Site 14627
Teva Investigational Site 53403
Teva Investigational Site 14642
Teva Investigational Site 52117
Teva Investigational Site 35227
Teva Investigational Site 52116
Teva Investigational Site 51287
Teva Investigational Site 51290
Teva Investigational Site 51283
Teva Investigational Site 51289
Teva Investigational Site 58300
Teva Investigational Site 32678
Teva Investigational Site 80130

summary: This is a multicenter, open-label (OL) extension study to obtain additional long-term safety data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The study consists of a screening/baseline visit followed by a 36-week OL treatment period and a 15-week follow-up period.


ipd_sharing: Yes

status: Active, not recruiting

acronym: LIMMITLESS

intervention_type: Biological

title: A Multicenter, Open Label Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS)

study_completion_date_type: Anticipated

lead_sponsor: AbbVie

type: Other Grant/Funding Number

ReferenceCitation: Papp KA, Lebwohl MG, Puig L, Ohtsuki M, Beissert S, Zeng J, Rubant S, Sinvhal R, Zhao Y, Soliman AM, Alperovich G, Leonardi C. Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis: interim analysis of the LIMMitless open-label extension trial beyond 3 years of follow-up. Br J Dermatol. 2021 Dec;185(6):1135-1145. doi: 10.1111/bjd.20595. Epub 2021 Sep 21.

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

enrollment_type: Anticipated

location_country:
Poland
Taiwan
Portugal
Spain
Austria
Australia
Mexico
Canada
Finland
Sweden
Korea, Republic of
United States
France
Belgium
Japan
Germany
Czechia

location_facility: Huntington Medical Foundation /ID# 154002

location_facility: Oregon Medical Res Center PC /ID# 154003

location_facility: The South Bend Clinic Center /ID# 154147

location_facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 153462

location_facility: Austin Dermatology Associates /ID# 154042

location_facility: Iwate Medical University Hospital /ID# 170843

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 153465

location_facility: National Hospital Organization Sagamihara National Hospital /ID# 153867

location_facility: Uniwersyteckie Centrum Kliniczne /ID# 153471

location_facility: Psoriasis Treatment Center of Central New Jersey /ID# 154001

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 153882

location_facility: St George Dermatology & Skin Cancer Centre /ID# 154308

location_facility: Suzanne Bruce and Associates-Houston /ID# 154026

location_facility: Universitaetsmedizin Goettingen /ID# 154091

location_facility: Massachusetts General Hospital /ID# 153990

location_facility: Juntendo University Hospital /ID# 200292

location_facility: National Taiwan University Hospital /ID# 154136

location_facility: Coastal Clinical Research Center of the Carolinas /ID# 154112

location_facility: Modern Research Associates, PL /ID# 154043

location_facility: Osaka Metropolitan University Hospital /ID# 153869

location_facility: Center for Clinical Studies - Webster TX /ID# 154150

location_facility: CCA Braga - Hospital de Braga /ID# 156323

location_facility: Virginia Clinical Research, Inc. /ID# 154016

location_facility: Kaiser Permanente Los Angeles /ID# 154079

location_facility: Rush University Medical Center /ID# 154099

location_facility: CMS3 Company for Medical Study /ID# 201318

location_facility: Klinische Forschung Schwerin GmbH /ID# 154291

location_facility: UNISON Center for Clinical Tri /ID# 153979

location_facility: Medizinische Universitaet Wien /ID# 154302

location_facility: Japan Organization of Occupational Health and Society Kanto Rosai Hospital /ID# 169172

location_facility: Universitaetsklinikum Frankfurt /ID# 153891

location_facility: Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 202490

location_facility: Dermatology Research Associates /ID# 153977

location_facility: Klinische Forschung Hamburg GmbH /ID# 154290

location_facility: University Hospital Kyoto Prefectural University of Medicine /ID# 169415

location_facility: Hokkaido University Hospital /ID# 154285

location_facility: Universitaetsklinik Heidelberg /ID# 153910

location_facility: Kansai Medical University Hospital /ID# 170884

location_facility: National Cheng Kung University Hospital /ID# 154135

location_facility: Total Skin and Beauty Derm Ctr /ID# 154000

location_facility: Hospital Santa Creu i Sant Pau /ID# 154125

location_facility: Taipei Medical University Shuang Ho Hospital /ID# 154134

location_facility: CHU Toulouse - Hopital Larrey /ID# 153951

location_facility: Derm Clin Res Ctr San Antonio /ID# 153978

location_facility: Dartmouth-Hitchcock Medical Center /ID# 154095

location_facility: High-Med Przychodnia Specjalistyczna /ID# 153468

location_facility: North Bay Dermatology Centre /ID# 153845

location_facility: Jichi Medical University Hospital /ID# 154286

location_facility: Eastern Canada Cutaneous Resea /ID# 153870

location_facility: Pusan National University Hospital /ID# 153485

location_facility: Synexus Clinical Research US, Inc. /ID# 154127

location_facility: Southern California Dermatology /ID# 154006

location_facility: Great Lakes Research Group, Inc. /ID# 153998

location_facility: Yamaguchi University Hospital /ID# 156322

location_facility: Progressive Clinical Research /ID# 154149

location_facility: The Jikei University Hospital /ID# 154080

location_facility: Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 153868

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 153948

location_facility: Seoul National University Bundang Hospital /ID# 153491

location_facility: Nagasaki University Hospital /ID# 170219

location_facility: Korea Universtiy Guro Hospital /ID# 153490

location_facility: Fukushima Medical University Hospital /ID# 153873

location_facility: Chonnam National University Hospital /ID# 153488

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 153884

location_facility: MUDr. Blanka Havlickova - dermatovenerologie /ID# 153888

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 153896

location_facility: University of Alabama at Birmingham - Main /ID# 153983

location_facility: Leavitt Medical Associates of Florida /ID# 154046

location_facility: Universitaetsklinikum Erlangen /ID# 154093

location_facility: Hospital General Universitario de Valencia /ID# 154126

location_facility: KonKuk University Medical Center /ID# 153483

location_facility: Yokohama City University Hospital /ID# 168831

location_facility: Center for Dermatology Clinical Research /ID# 154009

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 153906

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 153486

location_facility: Forest Hills Dermatology Group /ID# 154113

location_facility: Dermatology Consulting Service /ID# 154010

location_facility: Progressive Medical Research /ID# 154027

location_facility: Michigan Center for Skin Care Research /ID# 153986

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 154089

location_facility: Oregon Dermatology and Research Center /ID# 153982

location_facility: Seoul National University Hospital /ID# 153484

location_facility: Wilmington Dermatology Center /ID# 154109

location_facility: Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 153917

location_facility: The Indiana Clinical Trials Center /ID# 153976

location_facility: Icahn School of Medicine at Mount Sinai /ID# 154129

location_facility: Universitaetsklinikum Tuebingen /ID# 153912

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 153473

location_facility: Coastal Carolina Research Center /ID# 153992

location_facility: North Eastern Health Specialists /ID# 154309

location_facility: Florida Academic Centers Research /ID# 154045

location_facility: ActivMed Practices and Research, LLC. /ID# 154044

location_facility: Dermatology Associates of Seattle /ID# 153988

location_facility: California Dermatology and Research Institute /ID# 154007

location_facility: Center for Clinical Studies - Houston (Binz) /ID# 154005

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 154111

location_facility: Universitaetsklinikum Leipzig /ID# 153909

location_facility: Karolinska University Hospital Solna /ID# 154131

location_facility: Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 154289

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 153916

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 153463

location_facility: Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 156319

location_facility: Centro de Dermatologia de Monterrey /ID# 153881

location_facility: New England Research Associates, LLC /ID# 154004

location_facility: Bakersfield Derma & Skin Cance /ID# 154008

location_facility: DermaKiel Allergie und Haut Centrum /ID# 201316

location_facility: The Dermatology Center PSC - New Albany /ID# 154075

location_facility: CHP, EPE- Hospital Geral de Sa /ID# 153464

location_facility: Dermatology Specialists, Inc /ID# 153984

location_facility: Windsor Clinical Research, Inc /ID# 153877

location_facility: Dermatologische Gemeinschaftspraxis Mahlow /ID# 153892

location_facility: Dr. Chih-ho Hong Medical Inc. /ID# 153842

location_facility: Nagoya City University Hospital /ID# 153866

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 154092

location_facility: St.Luke's International Hospital /ID# 153863

location_facility: Sahlgrenska University Hospital /ID# 154132

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 154293

location_facility: Paratus Clinical Research Woden /ID# 154307

location_facility: Northshore University Health System Dermatology Clinical Trials Unit /ID# 154011

location_facility: Dermatology Ottawa Research Centre /ID# 153862

location_facility: Hamamatsu University Hospital /ID# 170132

location_facility: The Guenther Dermatology Research Centre /ID# 153841

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 153915

location_facility: IMTR - Grand Hopital de Charleroi /ID# 154298

location_facility: Gachon University Gil Medical Center /ID# 153489

location_facility: Dermatology Research Institute Inc. /ID# 153850

location_facility: Paddington Testing Co., Inc. /ID# 154022

location_facility: Epiphany Dermatology of Kansas LLC /ID# 153993

location_facility: Nihon University Itabashi Hospital /ID# 154081

location_facility: Klinika Ambroziak Sp. z o.o. /ID# 153467

location_facility: KO-MED Centra Kliniczne Lublin /ID# 153469

location_facility: DermResearchCenter of New York, Inc. /ID# 154012

location_facility: Minnesota Clinical Study Center /ID# 154015

location_facility: The Centre for Clinical Trials /ID# 153871

location_facility: Centre de recheche dermatologique du Quebec Metropolitain /ID# 153856

location_facility: York Dermatology Clinic and Research Centre /ID# 153860

location_facility: Hospital Universitario Infanta Leonor /ID# 154121

location_facility: Universitatsklinikum Munster /ID# 153895

location_facility: Northwestern University Feinberg School of Medicine /ID# 153974

location_facility: Nippon Medical School Hospital /ID# 154084

location_facility: Tokyo Medical University Hospital /ID# 153874

location_facility: ISA Interdisciplinary Study Association GmbH /ID# 153907

location_facility: Medical Cooperation Kojinkai Sapporo Skin Clinic /ID# 154083

location_facility: NW Arkansas Clinical Trials Center /ID# 154014

summary: The purpose of this study is to investigate the long-term safety and efficacy of risankizumab in the treatment of moderate to severe chronic plaque psoriasis.

status_simplified: Ongoing


title: A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of Voxelotor Administered Orally to Patients With Sickle Cell Disease

lead_sponsor: Global Blood Therapeutics

design_allocation: Randomized

ReferenceCitation: Howard J, Ataga KI, Brown RC, Achebe M, Nduba V, El-Beshlawy A, Hassab H, Agodoa I, Tonda M, Gray S, Lehrer-Graiwer J, Vichinsky E. Voxelotor in adolescents and adults with sickle cell disease (HOPE): long-term follow-up results of an international, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Haematol. 2021 May;8(5):e323-e333. doi: 10.1016/S2352-3026(21)00059-4. Epub 2021 Apr 7.

ReferenceCitation: Minniti CP, Knight-Madden J, Tonda M, Gray S, Lehrer-Graiwer J, Biemond BJ. The impact of voxelotor treatment on leg ulcers in patients with sickle cell disease. Am J Hematol. 2021 Apr 1;96(4):E126-E128. doi: 10.1002/ajh.26101. Epub 2021 Feb 19.

ReferenceCitation: Vichinsky E, Hoppe CC, Ataga KI, Ware RE, Nduba V, El-Beshlawy A, Hassab H, Achebe MM, Alkindi S, Brown RC, Diuguid DL, Telfer P, Tsitsikas DA, Elghandour A, Gordeuk VR, Kanter J, Abboud MR, Lehrer-Graiwer J, Tonda M, Intondi A, Tong B, Howard J; HOPE Trial Investigators. A Phase 3 Randomized Trial of Voxelotor in Sickle Cell Disease. N Engl J Med. 2019 Aug 8;381(6):509-519. doi: 10.1056/NEJMoa1903212. Epub 2019 Jun 14.

ReferenceCitation: Metcalf B, Chuang C, Dufu K, Patel MP, Silva-Garcia A, Johnson C, Lu Q, Partridge JR, Patskovska L, Patskovsky Y, Almo SC, Jacobson MP, Hua L, Xu Q, Gwaltney SL 2nd, Yee C, Harris J, Morgan BP, James J, Xu D, Hutchaleelaha A, Paulvannan K, Oksenberg D, Li Z. Discovery of GBT440, an Orally Bioavailable R-State Stabilizer of Sickle Cell Hemoglobin. ACS Med Chem Lett. 2017 Jan 23;8(3):321-326. doi: 10.1021/acsmedchemlett.6b00491. eCollection 2017 Mar 9.

location_country:
Kenya
United Kingdom
Italy
Oman
Lebanon
Canada
United States
France
Turkey
Netherlands
Jamaica
Egypt


type: Other Identifier

title: Phase 1 Open-label, Multicenter Study of MK-1454 Administered by Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab for Patients With Advanced/Metastatic Solid Tumors or Lymphomas

summary:
The purpose of this study is to identify a maximum tolerated dose (MTD) or maximum administered dose (MAD) of ulevostinag alone and of ulevostinag in combination with pembrolizumab in participants with advanced/metastatic solid tumors or lymphomas in Part 1, and to evaluate the safety and efficacy of ulevostinag via intratumoral (IT) injection in combination with pembrolizumab in selected solid tumors in Part 2.

Ulevostinag will be administered IT; pembrolizumab (pembro) will be administered via intravenous (IV) infusion. In Part 1, participants will be allocated to one of three treatment arms: ulevostinag monotherapy (cutaneous/subcutaneous [cut/subcut] lesions), ulevostinag +pembro (cut/subcut lesions), or ulevostinag +pembro (visceral lesions).

In Part 2, participants with head and neck squamous cell carcinoma (HNSCC) who are anti-programmed cell death-protein 1 or anti-programmed cell death-ligand 1 (anti-PD-1/PD-L1) refractory or with anti-PD-1/PD-L1 treatment (TrT)-naïve triple-negative breast cancer (TNBC) or with anti-PD-1/PD-L1 TrT-naïve solid tumors with liver metastases/lesions will receive ulevostinag via IT injection at the RP2D determined in Part 1 PLUS pembrolizumab via IV infusion for up 35 cycles (up approximately 2 years).

design_allocation: Non-Randomized

ReferenceCitation: Gogoi H, Mansouri S, Jin L. The Age of Cyclic Dinucleotide Vaccine Adjuvants. Vaccines (Basel). 2020 Aug 13;8(3). pii: E453. doi: 10.3390/vaccines8030453. Review.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
United Kingdom
Korea, Republic of
United States
Israel
France

location_facility: The Royal Marsden Foundation Trust ( Site 0031)

location_facility: The Royal Marsden NHS Foundation Trust. ( Site 0032)

location_facility: Mary Crowley Cancer Research Center ( Site 0001)

location_facility: University of California San Francisco ( Site 0007)


title: An Open-Label, Dose-Finding Study of Vedolizumab IV for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Patients Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)

lead_sponsor: Millennium Pharmaceuticals, Inc.

ReferenceCitation: Fløisand Y, Schroeder MA, Chevallier P, Selleslag D, Devine S, Renteria AS, Mohty M, Yakoub-Agha I, Chen C, Parfionovas A, Quadri S, Jansson J, Akbari M, Chen YB. A phase 2a randomized clinical trial of intravenous vedolizumab for the treatment of steroid-refractory intestinal acute graft-versus-host disease. Bone Marrow Transplant. 2021 Oct;56(10):2477-2488. doi: 10.1038/s41409-021-01356-0. Epub 2021 Jun 9.

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach 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.

location_country:
United States
France
Belgium
Norway
Sweden

location_facility: Oslo Universitetssykehus - Rikshospitalet

summary: The purpose of this study is to assess the initial activity, tolerability, safety and to identify a recommended dose and regimen of vedolizumab intravenous (IV) administered for treatment of steroid-refractory acute intestinal GvHD in participants who have undergone allo-HSCT.


status: Recruiting

title: An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, With Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase

lead_sponsor: Sanofi

location_country:
Spain
Ireland
Italy
Russian Federation
United Kingdom
Finland
Argentina
Canada
France
Germany
Bulgaria
Czechia

location_facility:
Investigational Site Number :3800052
Investigational Site Number :6430001
Investigational Site Number :2760061
Investigational Site Number :1240112
Investigational Site Number :2500041
Investigational Site Number :2760063
Investigational Site Number :3800054
Investigational Site Number :6430063
Investigational Site Number :7240052
Investigational Site Number :8260034
Investigational Site Number :3800051
Investigational Site Number :2500042
Investigational Site Number :0320004
Investigational Site Number :2760064
Investigational Site Number :2760060
Investigational Site Number :2460040
Investigational Site Number :2030042
Investigational Site Number :7240050
Investigational Site Number :7240051
Investigational Site Number :6430062
Investigational Site Number :2500040
Investigational Site Number :8260031
Investigational Site Number :3720001
Investigational Site Number :2760065
Investigational Site Number :6430065
Investigational Site Number :8260033
Investigational Site Number :1240110
Investigational Site Number :1000001
Investigational Site Number :7240053
Investigational Site Number :2760062

summary:
Primary Objective:

To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 1-17 years with Systemic Juvenile Idiopathic Arthritis (sJIA) in order to identify the dose and regimen for adequate treatment of this population.

Secondary Objective:

To describe the pharmacodynamics (PD) profile, the efficacy, and the long term safety of sarilumab in patients with sJIA.


title: An Adaptive, Open-Label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination With Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma

lead_sponsor: Eli Lilly and Company

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

More information provided by Eli Lilly and Company

location_country:
Taiwan
Spain
United Kingdom
Australia
United States
France
Israel
Belgium

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: University of Wisconsin-Madison Hospital and Health Clinic

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

summary: The purpose of this study is to evaluate the safety and efficacy of abemaciclib alone and in combination with other drugs versus standard of care in participants with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).


title: The European Paediatric Network for Haemophilia Management and the PedNet Haemophilia Registry

acronym: PedNet

summary:
Rationale:

Haemophilia is a rare disease; to improve knowledge international collaboration is needed. Well-defined clinical data will be collected from complete cohorts in order to prevent selection bias.

Objective:

To collect data on bleeding during neonatal period, endogenous (genetic) and exogenous (treatment-related) determinants of inhibitor development and long term outcome.

ReferenceType: result

ReferenceCitation: van den Berg HM, Gouw SC, van der Bom JG. Factor VIII products and inhibitors in severe hemophilia A. N Engl J Med. 2013 Apr 11;368(15):1457. doi: 10.1056/NEJMc1301995.

ReferenceCitation: Gouw SC, van den Berg HM, Fischer K, Auerswald G, Carcao M, Chalmers E, Chambost H, Kurnik K, Liesner R, Petrini P, Platokouki H, Altisent C, Oldenburg J, Nolan B, Garrido RP, Mancuso ME, Rafowicz A, Williams M, Clausen N, Middelburg RA, Ljung R, van der Bom JG; PedNet and Research of Determinants of INhibitor development (RODIN) Study Group. Intensity of factor VIII treatment and inhibitor development in children with severe hemophilia A: the RODIN study. Blood. 2013 May 16;121(20):4046-55. doi: 10.1182/blood-2012-09-457036. Epub 2013 Apr 3.

ReferenceCitation: Carcao MD, van den Berg HM, Ljung R, Mancuso ME; PedNet and the Rodin Study Group. Correlation between phenotype and genotype in a large unselected cohort of children with severe hemophilia A. Blood. 2013 May 9;121(19):3946-52, S1. doi: 10.1182/blood-2012-11-469403. Epub 2013 Mar 12.

ReferenceCitation: Clausen N, Petrini P, Claeyssens-Donadel S, Gouw SC, Liesner R; PedNet and Research of Determinants of Inhibitor development (RODIN) Study Group. Similar bleeding phenotype in young children with haemophilia A or B: a cohort study. Haemophilia. 2014 Nov;20(6):747-55. doi: 10.1111/hae.12470. Epub 2014 Jun 3.

ReferenceCitation: Fischer K, Ljung R, Platokouki H, Liesner R, Claeyssens S, Smink E, van den Berg HM. Prospective observational cohort studies for studying rare diseases: the European PedNet Haemophilia Registry. Haemophilia. 2014 Jul;20(4):e280-6. doi: 10.1111/hae.12448. Epub 2014 May 2.

ReferenceCitation: Gouw SC, van der Bom JG, Ljung R, Escuriola C, Cid AR, Claeyssens-Donadel S, van Geet C, Kenet G, Mäkipernaa A, Molinari AC, Muntean W, Kobelt R, Rivard G, Santagostino E, Thomas A, van den Berg HM; PedNet and RODIN Study Group. Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med. 2013 Jan 17;368(3):231-9. doi: 10.1056/NEJMoa1208024.

ReferenceCitation: Andersson NG, Auerswald G, Barnes C, Carcao M, Dunn AL, Fijnvandraat K, Hoffmann M, Kavakli K, Kenet G, Kobelt R, Kurnik K, Liesner R, Mäkipernaa A, Manco-Johnson MJ, Mancuso ME, Molinari AC, Nolan B, Perez Garrido R, Petrini P, Platokouki HE, Shapiro AD, Wu R, Ljung R. Intracranial haemorrhage in children and adolescents with severe haemophilia A or B - the impact of prophylactic treatment. Br J Haematol. 2017 Oct;179(2):298-307. doi: 10.1111/bjh.14844. Epub 2017 Jul 12.

ReferenceCitation: Mancuso ME, Fischer K, Santagostino E, Oldenburg J, Platokouki H, Königs C, Escuriola-Ettingshausen C, Rivard GE, Cid AR, Carcao M, Ljung R, Petrini P, Altisent C, Kenet G, Liesner R, Kurnik K, Auerswald G, Chambost H, Mäkipernaa A, Molinari AC, Williams M, van den Berg HM; European Pediatric Network for Haemophilia Management (PedNet) the REMAIN (REal life MAnagement of children with INhibitors) Study Group. Risk Factors for the Progression from Low to High Titres in 260 Children with Severe Haemophilia A and Newly Developed Inhibitors. Thromb Haemost. 2017 Dec;117(12):2274-2282. doi: 10.1160/TH17-01-0059. Epub 2017 Dec 6.

ReferenceCitation: Andersson NG, Chalmers EA, Kenet G, Ljung R, Mäkipernaa A, Chambost H; PedNet Haemophilia Research Foundation. Mode of delivery in hemophilia: vaginal delivery and Cesarean section carry similar risks for intracranial hemorrhages and other major bleeds. Haematologica. 2019 Oct;104(10):2100-2106. doi: 10.3324/haematol.2018.209619. Epub 2019 Feb 21.

ReferenceCitation: van den Berg HM, Fischer K, Carcao M, Chambost H, Kenet G, Kurnik K, Königs C, Male C, Santagostino E, Ljung R; PedNet Study Group. Timing of inhibitor development in more than 1000 previously untreated patients with severe hemophilia A. Blood. 2019 Jul 18;134(3):317-320. doi: 10.1182/blood.2019000658. Epub 2019 Jun 11.

ReferenceCitation: Male C, Andersson NG, Rafowicz A, Liesner R, Kurnik K, Fischer K, Platokouki H, Santagostino E, Chambost H, Nolan B, Königs C, Kenet G, Ljung R, Van den Berg M. Inhibitor incidence in an unselected cohort of previously untreated patients with severe haemophilia B: a PedNet study. Haematologica. 2021 Jan 1;106(1):123-129. doi: 10.3324/haematol.2019.239160.

ReferenceCitation: van den Berg HM, Mancuso ME, Königs C, D'Oiron R, Platokouki H, Mikkelsen TS, Motwani J, Nolan B, Santagostino E; European Pediatric Network for Haemophilia Management (PedNet). ITI Treatment is not First-Choice Treatment in Children with Hemophilia A and Low-Responding Inhibitors: Evidence from a PedNet Study. Thromb Haemost. 2020 Aug;120(8):1166-1172. doi: 10.1055/s-0040-1713097. Epub 2020 Jun 22.

ReferenceCitation: Andersson NG, Wu R, Carcao M, Claeyssens-Donadel S, Kobelt R, Liesner R, Mäkipernaa A, Ranta S, Ljung R; ICH study group. Long-term follow-up of neonatal intracranial haemorrhage in children with severe haemophilia. Br J Haematol. 2020 Jul;190(2):e101-e104. doi: 10.1111/bjh.16740. Epub 2020 Jun 9.

ReferenceCitation: Platokouki H, Fischer K, Gouw SC, Rafowicz A, Carcao M, Kenet G, Liesner R, Kurnik K, Rivard GE, van den Berg HM. Vaccinations are not associated with inhibitor development in boys with severe haemophilia A. Haemophilia. 2018 Mar;24(2):283-290. doi: 10.1111/hae.13387. Epub 2017 Dec 15.

ReferenceCitation: Khair K, Ranta S, Thomas A, Lindvall K; PedNet study group. The impact of clinical practice on the outcome of central venous access devices in children with haemophilia. Haemophilia. 2017 Jul;23(4):e276-e281. doi: 10.1111/hae.13241. Epub 2017 May 24.

ReferenceCitation: Hashemi SM, Fischer K, Moons KGM, van den Berg HM; PedNet Study group. Validation of the prediction model for inhibitor development in PUPs with severe haemophilia A. Haemophilia. 2016 Mar;22(2):e116-e118. doi: 10.1111/hae.12895. Epub 2016 Feb 8.

lead_sponsor: PedNet Haemophilia Research Foundation

location_country:
Denmark
Portugal
Spain
Greece
Austria
Ireland
Italy
Canada
Finland
Netherlands
Switzerland
Sweden
France
Israel
United Kingdom
Belgium
Norway
Germany
Czechia

location_facility: University Hospital Frankfurt & Goethe University - Clinical and Molecular Hemostasis, Department of Pediatrics

location_facility: Division of Hematology/Oncology Hôpital St Justine

location_facility: The National Hemophilia Center Sheba Medical Center, Tel Hashomer

location_facility: Unidad de Coagulopatias Congenitas Hospital Universitario la Fe

location_facility: Department of Haematology Royal Hospital for Sick Children

location_facility: Service d'Hématologie Pédiatrique Hôpital Universitaire La Timone

location_facility: Division of Haematology/Oncology Hospital for Sick Children

location_facility: Centro Hospitalar São João, S. Imuno-hemoterapia

location_facility: Department of Paediatric Haematology/oncology - University Hospital Motol

location_facility: Birmingham Children's Hospital NHS Trust - Department of Haematology

location_facility: Medical University of Vienna - Department of Paediatrics

location_facility: Haemophila Center Great Ormond Street Hospital for Children

location_facility: Hospital General Unidad de Hemofilia 1 Sur Hospitales Universitarios Virgen del Rocio

location_facility: Inselspital Bern, University Children's Hospital

location_facility: Service of Pediatric Haematology University Hospital Leuven

location_facility: Haemophilia-Haemostasis Unit St. Sophia Children's Hospital

location_facility: Haemophilia Comprehensive Care Centre, Centre for Thrombosis and Haemostasis Children's University Hospital Brno

location_facility: Service Hématologique Centre Regional Traitement d'Hemophilie Bicetre

location_facility: Unidad de Coagulopatías Hospital Universitario La Paz

location_facility: Institut für Experimentelle Hämatologie und Transfusionsmedizin Universitätsklinikum Bonn

location_facility: Centre de traitement des hémophiles Hôpital Universitaire Purpan

location_facility: Dept of Paediatric Haematology Our Lady's Children's Hospital for Sick Children Crumlin

location_facility: Department of Pediatrics Århus Kommunehospital Skejby Sygehus

location_facility: Van Creveld Kliniek University Medical Center Utrecht

location_facility: Children's Hospital Helsinki University Hospital

location_facility: Department of Pediatrics, Clinic of Coag. Disorders Karolinska Hospital

location_facility: Dr. v. Haunersches Kinderspital University of Munich

location_facility: Universitäts-Klinik für Kinder- und Jugendheilkunde

location_facility: A. Bianchi Bonomi Hemophilia and Thrombosis Centre IRCCS Ca' Granda Ospedale Maggiore Policlinico


title: A Phase Ib, Open-label, Multicenter Study of Oral LXH254-centric Combinations in Adult Patients With Advanced or Metastatic KRAS or BRAF Mutant Non-Small Cell Lung Cancer or NRAS Mutant Melanoma

summary: To characterize safety and tolerability and identify a recommended dose and regimen for the LXH254 in combination with LTT462 or trametinib or ribociclib.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Poland
Spain
Italy
Australia
Sweden
Korea, Republic of
United States
France
Israel
Belgium
Germany

location_facility: Sarah Cannon Research Institute Tennessee Oncology

location_facility: University of Texas MD Anderson Cancer Center


title: A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC With Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy (IIM)

lead_sponsor: Bristol-Myers Squibb

location_country:
Brazil
Italy
Australia
Sweden
Korea, Republic of
United States
France
Mexico
Japan
Germany
Czechia

location_facility: The Ohio State University Wexner Medical Center (OSUWMC) - CarePoint East

location_facility: Harvard Medical School - Brigham and Women's Hospital (BWH) - The Schuster Family Transplantation Re

location_facility: George Washington Medical Faculty Associates

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

summary: Trial to Evaluate the Efficacy and Safety of Abatacept subcutaneous (SC) in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy


title: Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye

summary: The objectives of this study are twofold •To evaluate the safety and efficacy of 0.1% AGN-195263 administered twice daily compared to its vehicle in patients with evaporative dry eye (EDE) •To evaluate the systemic pharmacokinetics of 0.1% AGN-195263 administered twice daily in patients with EDE

lead_sponsor: Allergan

location_country:
Poland
Taiwan
Spain
Italy
United Kingdom
Hungary
United States
France
Turkey
Philippines
Germany
Czechia

location_facility: Ludwig-Maximilians-University, Dept of Ophthalmology

location_facility: Uniwersyteck Szpital Kliniczny im. Jana Mikulicza-Radeckiego

location_facility: CHU Hopital Morvan (Bat 4) Service Daviel Ophtalmologie

location_facility: Clinico de Barcelona Casa de la Maternidad

location_facility: Newcastle University School of Medicine, Dept of Ophthamology

location_facility: University Hospital of Cologne, Dept of Ophthalmology

location_facility: Rapallo Hospital, Opthalmology Department

location_facility: University of Szeged Szent-Györgyi Albert Clinical Center, Faculty of Medicine, Dept of Ophthalmology

location_facility: Specjalistyczna Praktyka Lekarska prof. Edward Wylegala

location_facility: Istituto Di Ricovero E Cura A Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

location_facility: University of Debrecen, Dept of Opthalmology, (DE OEC Szemklinika)

location_facility: University of Valladolid, Facultad Medicina

location_facility: Gutenberg University Medical School, Dept of Ophthalmology

location_facility: University of Pisa, Neurosciences - Section of Ophthalmology

location_facility: Institto de Microcirugia Ocular C/Josep Maria Llado

location_facility: Ospedale San Giuseppe, Universita di Milano

location_facility: Dept. of Ophthalmology Semmelweis University

location_facility: CHU de Bordeaux, Service d'Ophtalmologie


title: A Phase I/II Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK525762 in Combination With Fulvestrant in Subjects With Hormone Receptor-positive/HER2-negative (HR+/HER2-) Advanced or Metastatic Breast Cancer

lead_sponsor: GlaxoSmithKline

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

location_country:
Spain
United Kingdom
Australia
Canada
Korea, Republic of
United States
France

summary: This is a combination Phase I and Phase II study, with an aim to evaluate the combination of GSK525762 and fulvestrant in women with HR+/HER2- advanced or metastatic breast cancer, who have disease that has progressed after prior treatment with at least one line of endocrine therapy. The objectives of the study are to first identify, in open-label single-arm Phase I, a recommended Phase II dose of GSK525762 that may be combined safely with fulvestrant. Phase I will follow a modified toxicity probability interval (mTPI) design, and a sentinel group will be evaluated first for dose-limiting toxicity and further expanded to collect additional safety data. This will be followed by a double-blind, randomized controlled Phase II, to identify the clinical activity of the two study treatments when given in combination. The composition of Phase II will be selected at the end of Phase I.


title: Long-Term Tolerability and Safety of Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

lead_sponsor: Baxalta now part of Shire

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

location_country:
Denmark
Poland
Brazil
Serbia
Spain
Greece
Italy
Mexico
United Kingdom
Argentina
Canada
United States
France
Turkey
Colombia
Germany
Slovakia
Czechia

location_facility: Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran

location_facility: Instituto de Neurologia de Curitiba - Hospital Ecoville

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"

location_facility: Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi

location_facility: Toronto General Hospital, University Health Network

location_facility: Dokuz Eylul University Faculty of Medicine

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

location_facility: Fondazione Istituto Neurologico Casimiro Mondino

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

summary:
Adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who have completed study 161403 will be able to take part in this study.

The main aim of the study is to evaluate side effects in the long-term treatment with HYQVIA/HyQvia.

All participants will receive HYQVIA/HyQvia in the same way as they were receiving in study 161403. The dosing interval of HYQVIA/HyQvia can be adjusted after 12 weeks of treatment in study 161505 if the study doctor determines that it is safe to do so.

Participants will visit the clinic within 1 week after the first and second dose of HYQVIA/HyQvia and then every 12 weeks for the duration of the study.


title: An Open Label Phase II Study to Evaluate the Efficacy and Safety of PDR001 in Patients With Advanced or Metastatic, Well-differentiated, Non-functional Neuroendocrine Tumors of Pancreatic, Gastrointestinal (GI), or Thoracic Origin or Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC), That Have Progressed on Prior Treatment.

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

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
United States
France
Belgium
Japan
Germany

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: University of TX MD Anderson Cancer Center

summary: This study aimed to investigate the efficacy and safety of PDR001 in patients with advanced or metastatic, well-differentiated, non-functional neuroendocrine tumors of pancreatic, gastrointestinal (GI), or thoracic origin or poorly-differentiated gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC) that progressed on prior treatment.


title: A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Szabados B, Ponz-Sarvisé M, Machado R, Saldana D, Kadel EE, Banchereau R, Bouquet F, Garmhausen M, Powles T, Schröder C; imCORE Working Group of Early Career Investigators (imFLAME). Clinico-Genomic Characterization of Patients with Metastatic Urothelial Carcinoma in Real-World Practice Identifies a Novel Bladder Immune Performance Index (BIPI). Clin Cancer Res. 2022 Sep 15;28(18):4083-4091. doi: 10.1158/1078-0432.CCR-22-0200.

ReferenceCitation: Vander Velde N, Guerin A, Ionescu-Ittu R, Shi S, Wu EQ, Lin SW, Hsu LI, Saum KU, de Ducla S, Wang J, Li S, Thåström A, Liu S, Shi L, Leppert JT. Comparative Effectiveness of Non-cisplatin First-line Therapies for Metastatic Urothelial Carcinoma: Phase 2 IMvigor210 Study Versus US Patients Treated in the Veterans Health Administration. Eur Urol Oncol. 2019 Feb;2(1):12-20. doi: 10.1016/j.euo.2018.07.003. Epub 2018 Aug 4.

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

location_facility: The Angeles Clinic and Research Institute - W LA Office

location_facility: University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Institut Gustave Roussy; Oncologie Medicale

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Beth Israel Deaconess Medical Center, Harvard Medical School; Department of Medicine

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Dana Farber Cancer Inst. ; Dept. of Medical Oncology

location_facility: Mount Sinai School of Medicine - Tisch Cancer Institute

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Kimmel Cancer Center Thomas Jefferson University

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie

location_facility: Indiana University Health; Goshen Center for Cancer Care

location_facility: Virginia Oncology Associates - Lake Wright Cancer Center

location_facility: Willamette Valley Cancer Ctr - 520 Country Club

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: University of Chicago; Hematology/Oncology

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Universitätsklinikum Düsseldorf; Urologische Klinik

location_facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Urology Cancer Center & GU Research Network

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis

summary: This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 (reported here) will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. The results of the second cohort are reported separately (NCT02108652). Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity.


title: Multicenter Phase II Safety and Preliminary Efficacy Study of 2 Dose Regimens of HepaStem in Patients With Acute on Chronic Liver Failure

lead_sponsor: Promethera Therapeutics

location_country: France Belgium

location_facility:
UZ Antwerpen
Hôpital Erasme
UZ Gent
KU Leuven
Cliniques St Luc
Hôpital Beaujon
Hôpital de la Croix Rousse
CHU Brugmann
CHU de Liège
Hôpital Paul Brousse

summary: The study will assess the safety of different dose regimens of HepaStem in cirrhotic Patients with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active study period.


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Single Dose of ASN100 for the Prevention of Staphylococcus Aureus Pneumonia in Heavily Colonized, Mechanically Ventilated Subjects

summary: The purpose of this study is the prevention of Staphylococcus aureus pneumonia in mechanically ventilated subjects heavily colonized with S. aureus. Staphylococcus aureus is a human pathogenic bacterium that causes severe infections, including pneumonia and sepsis. Hospital-acquired bacterial pneumonia (HABP) caused by S. aureus, including ventilator-associated bacterial pneumonia (VABP) in mechanically ventilated subjects, is a significant public health threat despite efforts to optimize antibiotic treatment. ASN100 is an investigational monoclonal antibody product that targets the toxins produced by S. aureus to protect subjects from developing S. aureus pneumonia.

primary_purpose: Prevention

lead_sponsor: Arsanis, Inc.

location_country:
Poland
Portugal
Serbia
Spain
Austria
Georgia
Russian Federation
Ukraine
Hungary
United States
France
India
Israel
Romania
South Africa
Czechia

location_facility:
Research Site 688-002
Research Site 268-006
Research Site 688-004
Research Site 688-003
Research Site 688-001
Research Site 268-005
Research Site 040-002
Research Site 268-009
Research Site 268-008
Research Site 268-002
Research Site 268-003
Research Site 268-010
Research Site
Research Site 268-001
Research Site 268-007
Research Site 268-011
Research Site 040-001
Research Site 688-005
Research Site 268-004


title: Efficacy and Safety of SAR156597 in the Treatment of Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Randomized, Double-blind, Placebo-controlled, 24-week, Proof of Concept Study

summary:
Primary Objective:

To evaluate, in comparison with placebo, the efficacy of SAR156597 administered subcutaneously for 24 weeks on skin fibrosis in participants with diffuse cutaneous systemic sclerosis (dcSSc).

Secondary Objectives:

To evaluate the efficacy of SAR156597 compared to placebo on physical/functional disability in participants with dcSSc.
To evaluate the efficacy of SAR156597 compared to placebo on respiratory function of participants with dcSSc.
To evaluate the safety profile of SAR156597 compared to placebo in participants with dcSSc.
To evaluate the potential for immunogenicity (anti-drug antibodies response) of SAR156597 in participants with dcSSc.
To evaluate the pharmacokinetics (trough plasma concentrations) of SAR156597 administered subcutaneously for 24 weeks.

ReferenceCitation: Allanore Y, Wung P, Soubrane C, Esperet C, Marrache F, Bejuit R, Lahmar A, Khanna D, Denton CP; Investigators. A randomised, double-blind, placebo-controlled, 24-week, phase II, proof-of-concept study of romilkimab (SAR156597) in early diffuse cutaneous systemic sclerosis. Ann Rheum Dis. 2020 Dec;79(12):1600-1607. doi: 10.1136/annrheumdis-2020-218447. Epub 2020 Sep 22.

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

location_country:
Poland
Romania
United Kingdom
Italy
Russian Federation
Estonia
Mexico
Argentina
Ukraine
United States
France
Belgium
Germany

location_facility:
Investigational Site Number 6430002
Investigational Site Number 2500002
Investigational Site Number 6420001
Investigational Site Number 8260001
Investigational Site Number 6160002
Investigational Site Number 4840002
Investigational Site Number 2500003
Investigational Site Number 0560001
Investigational Site Number 0320003
Investigational Site Number 6160003
Investigational Site Number 0560002
Investigational Site Number 6430005
Investigational Site Number 6420005
Investigational Site Number 6420003
Investigational Site Number 2760003
Investigational Site Number 6430004
Investigational Site Number 3800006
Investigational Site Number 2760002
Investigational Site Number 8400007
Investigational Site Number 8400005
Investigational Site Number 8040001
Investigational Site Number 4840003
Investigational Site Number 6430003
Investigational Site Number 6420002
Investigational Site Number 4840001
Investigational Site Number 8400002
Investigational Site Number 8400006
Investigational Site Number 6420004
Investigational Site Number 8040003
Investigational Site Number 2500004
Investigational Site Number 0320002
Investigational Site Number 6430001
Investigational Site Number 0320001
Investigational Site Number 3800005
Investigational Site Number 0320005
Investigational Site Number 3800004
Investigational Site Number 8040004
Investigational Site Number 2330001
Investigational Site Number 4840005
Investigational Site Number 6160001
Investigational Site Number 2760001
Investigational Site Number 3800001
Investigational Site Number 2760004
Investigational Site Number 8040002


acronym: OUTSTEP-HF

title: A Multi-center, Prospective, Randomized, Double-blind Study to Assess the Impact of Sacubitril/Valsartan vs. Enalapril on Daily Physical Activity Using a Wrist Worn Actigraphy Device in Adult Chronic Heart Failure Patients

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

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

location_country:
Denmark
Poland
Spain
Greece
Ireland
Estonia
Latvia
Finland
Lithuania
Netherlands
United Kingdom
Sweden
France
Norway
Belgium
Iceland
Germany
Bulgaria
Czechia

summary: The purpose of this randomized, actively controlled, double-blind study with prospective data collection was to assess differences between sacubitril/valsartan versus enalapril in increasing exercise capacity and non-sedentary physical activity in HFrEF patients. Physical activity was assessed by the 6 minute walk test, and daily physical activity was continuously measured by means of a wrist-worn accelerometry device from 2 weeks before until 12 weeks after start of study therapy (sacubitril/valsartan or enalapril).


title: Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 18 Years of Age

summary: Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD

lead_sponsor: H. Lundbeck A/S

location_country:
Poland
Serbia
Spain
Italy
Latvia
Estonia
Mexico
Canada
Russian Federation
United Kingdom
Ukraine
Hungary
Korea, Republic of
United States
France
Israel
South Africa
Colombia
Germany
Bulgaria

location_facility: Medicorehabilitation Research Center Phoenix

location_facility: Klinik fur Kinderneurologie und Sozialpadiatrie Kinderzentrum Maulbronn gGmbH

location_facility: Yaroslavl Regional Clinical Psychiatry Hospital

location_facility: E.S.E. Hospital Mental de Antioquia HOMO

location_facility: Przychodnia Syntonia Poradnia Zdrowia Psychicznego

location_facility: Arkhangelsk Regional Clinical Mental Hospital

location_facility: Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri

location_facility: Specjalistyczny Szpital im. dra A. Sokolowskiego w Walbrzychu

location_facility: Stavropol Region Psychiatric Hospital No.2

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

location_facility: University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry

location_facility: City Psychiatric Hospital No.3 named after I.I. Skvortsov-Stepanov

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.

location_facility: Maltsev Poltava Regional Clinical Psychiatric Hospital, Higher State Educational Institution Of U...

location_facility: LLC City Neurological Center Sibneuromed

location_facility: Kansas University School of Medicine-Wichita

location_facility: Ukrainian Research Institute Of Social, Forensic Psychiatry And Drug Abuse, Kiev City Psychoneuro...

location_facility: Nizhny Novgorod Region State Institution Of Healthcare Clinical Psychiatric Hospital 1 Of Nizhny ...

location_facility: Diagnostic Consultative Center Mladost-M Varna OOD

location_facility: Soon Chun Hyang University Hospital Cheonan

location_facility: U.O.C. Neuropsichiatria Infantile - IRCCS Istituto Giannina Gaslini

location_facility: Spectrum Centrum Psychiatrii Specjalistyczny Gabinet Psychiatryczny

location_facility: Rostov State Medical University of the Minzdravsotsrazvitiya of Russia

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: State Budgetary Healthcare Institution of Sverdlovsk Region Â¿Sverdlovsk Regional Clinical Psychi...

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C

location_facility: Odessa Regional Medical Centre of Mental Health

location_facility: Ternopil Regional Clinical Municipal Psycho-Neurological Hospital, Ternopil State Medical Univers...

location_facility: Daily Hospital for Children and Adolescents

location_facility: Vadaskert Child Psychiatric Hospital and Outpatient

location_facility: NHS Greater Glasgow and Clyde Glasgow Clinical Research Facility-Queen Elizabeth University Hospi...

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Scientific Institute Fondazione Stella Maris

location_facility: CRI Centro Regiomontano de Investigacion SC

location_facility: Filip Rybakowski Specjalistyczna Praktyka Lekarska

location_facility: Lipetsk Regional Psychoneurological Hospital

location_facility: The University of Arizona Sarver Heart Center (SHC)

location_facility: Guz Saratov Regional Psychiatric Hospital St. Sofii

location_facility: Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo

location_facility: State Budgetary Healthcare Institution (SBHI) Specialized Clinical Psychiatric Hospital 1 of the ...

location_facility: Child and Adolescent Neurology and Psychiatry Clinic

location_facility: Centrum Badan Klinicznych PI-House Sp. z o.o.

location_facility: Dip.Sc.Biomediche, Odont. e Imm.Funz.li, AOU Policlinico G. Martino

location_facility: Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS

location_facility: Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)

location_facility: Clinical Center of Vojvodina - Clinic of Psychiatry


title: A Phase 2, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of GS-5745 Combined With Nivolumab Versus Nivolumab Alone in Subjects With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma

summary: The primary objective of this study is to evaluate and compare the efficacy of andecaliximab (GS-5745) in combination with nivolumab versus nivolumab alone in adults with recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma.

ReferenceCitation: Shah MA, Cunningham D, Metges JP, Van Cutsem E, Wainberg Z, Elboudwarej E, Lin KW, Turner S, Zavodovskaya M, Inzunza D, Liu J, Patterson SD, Zhou J, He J, Thai D, Bhargava P, Brachmann CB, Cantenacci DVT. Randomized, open-label, phase 2 study of andecaliximab plus nivolumab versus nivolumab alone in advanced gastric cancer identifies biomarkers associated with survival. J Immunother Cancer. 2021 Dec;9(12). pii: e003580. doi: 10.1136/jitc-2021-003580.

lead_sponsor: Gilead Sciences

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Hungary
United States
France
Belgium


title: A Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With Relapsed or Refractory Malignant Mesothelioma With BAP1 Loss of Function

summary:
This is a Phase 2, multicenter, open-label, 2-part, single-arm, 2-stage study of tazemetostat 800 mg two times a day (BID) administered orally. Screening of subjects to determine eligibility for the study will be performed within 21 days of the first planned dose of tazemetostat.

In Part 1: planned to enroll 12 subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status will be treated and undergo pharmacokinetics (PK) blood sample collection after a single tazemetostat 800 mg.

Part 2 plans to include 55 subjects with BAP1-deficient relapsed or refractory malignant mesothelioma.

Treatment with tazemetostat will continue until disease progression, unacceptable toxicity or withdrawal of consent, or termination of the study. Response assessment will be evaluated after 6 weeks of treatment and then every 12 weeks thereafter while on study.

ReferenceCitation: Zauderer MG, Szlosarek PW, Le Moulec S, Popat S, Taylor P, Planchard D, Scherpereel A, Koczywas M, Forster M, Cameron RB, Peikert T, Argon EK, Michaud NR, Szanto A, Yang J, Chen Y, Kansra V, Agarwal S, Fennell DA. EZH2 inhibitor tazemetostat in patients with relapsed or refractory, BAP1-inactivated malignant pleural mesothelioma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2022 Jun;23(6):758-767. doi: 10.1016/S1470-2045(22)00277-7. Epub 2022 May 16.

ipd_sharing_description: To be determined.

lead_sponsor: Epizyme, Inc.

location_country:
United States
United Kingdom
France

location_facility: University of Leicester & Leicester University Hospitals


title: A Randomized, Double-blind, Placebo Controlled, 3- Part, Adaptive Design, Multicenter Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH): FLIGHT-FXR

acronym: FLIGHT-FXR

summary: The purpose of the study was to assess the effects of different doses of tropifexor (LJN452) with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH

ReferenceCitation: Naoumov NV, Brees D, Loeffler J, Chng E, Ren Y, Lopez P, Tai D, Lamle S, Sanyal AJ. Digital pathology with artificial intelligence analyses provides greater insights into treatment-induced fibrosis regression in NASH. J Hepatol. 2022 Nov;77(5):1399-1409. doi: 10.1016/j.jhep.2022.06.018. Epub 2022 Jun 30.

ipd_sharing: Undecided

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

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

location_country:
Taiwan
Spain
Italy
Austria
Australia
Netherlands
Argentina
Canada
Korea, Republic of
United States
France
India
Singapore
Belgium
Japan
Germany
Slovakia


acronym: HAVEN 3

title: A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Patients Without Inhibitors

ReferenceCitation: Kruse-Jarres R, Peyvandi F, Oldenburg J, Chang T, Chebon S, Doral MY, Croteau SE, Lambert T, Kempton CL, Pipe SW, Ko RH, Trzaskoma B, Dhalluin C, Bienz NS, Niggli M, Lehle M, Paz-Priel I, Young G, Jiménez-Yuste V. Surgical outcomes in people with hemophilia A taking emicizumab prophylaxis: experience from the HAVEN 1-4 studies. Blood Adv. 2022 Aug 8. pii: bloodadvances.2022007458. doi: 10.1182/bloodadvances.2022007458. [Epub ahead of print]

ReferenceCitation: Kiialainen A, Niggli M, Kempton CL, Castaman G, Chang T, Paz-Priel I, Adamkewicz JI, Levy GG. Effect of emicizumab prophylaxis on bone and joint health markers in people with haemophilia A without factor VIII inhibitors in the HAVEN 3 study. Haemophilia. 2022 Jul 29. doi: 10.1111/hae.14642. [Epub ahead of print]

ReferenceCitation: Mahlangu J, Oldenburg J, Paz-Priel I, Negrier C, Niggli M, Mancuso ME, Schmitt C, Jiménez-Yuste V, Kempton C, Dhalluin C, Callaghan MU, Bujan W, Shima M, Adamkewicz JI, Asikanius E, Levy GG, Kruse-Jarres R. Emicizumab Prophylaxis in Patients Who Have Hemophilia A without Inhibitors. N Engl J Med. 2018 Aug 30;379(9):811-822. doi: 10.1056/NEJMoa1803550.

location_country:
Poland
Taiwan
Spain
Ireland
Italy
Australia
United Kingdom
Korea, Republic of
United States
Costa Rica
France
South Africa
Japan
Germany

location_facility: Dana-Farber Cancer Institute; Brigham and Women's Cancer Center

location_facility: Children's Hospital of Michigan; Pediatrics

location_facility: The Alfred Hospital, Melbourne; Thrombosis and Haemostasis Unit

location_facility: Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych

location_facility: CH de Bicetre; Centre de Traitement d' Hemophilie

location_facility: Bloodworks Northwest (formerly Puget Sound Blood Center); Hemophilia

location_facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico; Centro Emofilia e Trombosi "Angelo Bianchi e Bonomi"

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Universitätsklinikum Bonn; Institut für Experimentelle Hämatologie und Transfusionsmedizin

location_facility: ALVAMED Lekarskie Gabinety Specjalistyczne

location_facility: Hopital Cardio-vasculaire Louis Pradel; Hemostase clinique

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Georgetown Uni Medical Center; Lombardi Cancer Center

location_facility: Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Cornell Univ Medical College; Hematology-Oncolog

summary: This is a randomized, global, multicenter, open-label, Phase 3 clinical study in participants with severe hemophilia A without inhibitors against Factor VIII (FVIII) who are 12 years or older. The study evaluates two prophylactic emicizumab regimens versus no prophylaxis in this population with emphasis on efficacy, safety, and pharmacokinetics.