NCT04267393
Recruiting
February 12, 2020
May 5, 2022
Brief summary:
The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Dose A BMS-986263 |
Drug: BMS-986263 Specified dose on specified days |
Experimental: Dose B BMS-986263 |
Drug: BMS-986263 Specified dose on specified days |
Placebo Comparator: Placebo |
Other: Placebo Specified dose on specified days |
Inclusion Criteria: Participants with liver biopsy fibrosis score stage 4 (NASH CRN) performed within 6 months Men and women must agree to follow methods of contraception Exclusion Criteria: Worsening liver disease or any disease might compromise participant safety in the opinion of the investigator Known immunocompromised status or any disease or condition which might compromise participant safety Prior exposure to BMS-986263 Clinically relevant abnormal physical examination, vital signs, ECG, or clinical laboratory tests Hepatic decompensation Other protocol-defined inclusion/exclusion criteria apply
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
United States, Arizona
Local Institution
Phoenix
United States, Arizona
Local Institution
Phoenix
United States, Arkansas
Local Institution
Little Rock
United States, California
Local Institution
Redwood City
United States, California
Local Institution
San Diego
United States, Connecticut
Local Institution
Bridgeport
United States, Florida
Local Institution
Leesburg
United States, Florida
Schiff Center for Liver Diseases
Miami
United States, Florida
Clinical Site Partners - Orlando
Winter Park
United States, Iowa
University of Iowa-Internal Medicine
Iowa City
United States, Louisiana
Local Institution
Lake Charles
United States, Louisiana
Tulane University School of Medicine-Gastroenterology and Hepatology
New Orleans
United States, Maryland
Local Institution
Baltimore
United States, Massachusetts
Local Institution
Fall River
United States, Michigan
Local Institution
Wyoming
United States, Missouri
Local Institution
Kansas City
United States, Nebraska
Local Institution
Omaha
United States, New York
Local Institution
Buffalo
United States, New York
Local Institution
New York
United States, Ohio
Local Institution
Middleburg Heights
United States, Pennsylvania
Local Institution
Philadelphia
United States, Pennsylvania
Local Institution
Philadelphia
United States, Pennsylvania
Local Institution
Philadelphia
United States, Tennessee
Local Institution
Memphis
United States, Texas
Local Institution
Dallas
United States, Texas
Local Institution
Houston
United States, Texas
Local Institution
Houston
United States, Texas
Local Institution
McAllen
United States, Texas
Texas Liver Institute
San Antonio
United States, Virginia
Local Institution
Richmond
Argentina, Buenos Aires
Local Institution - 0089
Ciudad de Buenos Aires
Argentina, Buenos Aires
Local Institution
Florencio Varela
Argentina, Distrito Federal
Local Institution
Ciudad Autonoma de Buenos Aires
Belgium
Local Institution
Anderlecht
Belgium
Local Institution
Bruxelles
Belgium
Local Institution
Edegem
Belgium
Local Institution
Gent
Belgium
Local Institution
Leuven
Brazil, Bahia
Local Institution
Salvador
Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre
Brazil, SAO Paulo
Local Institution
Botucatu
Brazil, SAO Paulo
Local Institution
Ribeirão Preto
Brazil, SAO Paulo
Local Institution
São Paulo
Brazil
Local Institution - 0120
Sao Paulo
Brazil
Local Institution
Sao Paulo
Canada, British Columbia
Local Institution
Victoria
Canada, Ontario
Local Institution
Toronto
France
Local Institution
Nice
Germany
Charité Campus Virchow-Klinikum-Hepatology
Berlin
Germany
Local Institution
Bonn
Germany
Universitaetsklinikum Essen
Essen
Germany
Local Institution - 0082
Frankfurt
Germany
Local Institution - 0096
Hannover
Germany
Local Institution
Homburg
Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel-Allgemeine Innere Medizin I
Kiel
Germany
Local Institution
Luebeck
Germany
Local Institution - 0071
Mainz
Germany
Klinikum der Universität München Großhadern-Medizinische Klinik und Poliklinik II
Munich
Israel
Local Institution
Haifa
Israel
Local Institution
Petah Tikva
Israel
Local Institution - 0058
Ramat Gan
Israel
Local Institution
Tel Aviv
Italy
Local Institution
Bologna
Italy
Local Institution
Messina
Italy
A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic
Palermo
Italy
Local Institution
Pisa
Italy
Local Institution
Rome
Japan, Ehime
Local Institution
Toon
Japan, Fukuoka
Local Institution
Kurume
Japan, Hiroshima
Local Institution
Hiroshima-shi
Japan, Hokkaido
Local Institution
Sapporo
Japan, Iwate
Local Institution
Shiwa-gun
Japan, Kanagawa
Local Institution
Yokohama
Japan, Kyoto
Local Institution
Kyoto-shi
Japan, Nagano
Local Institution
Matsumoto
Japan, Nara
Local Institution
Kashihara-shi
Japan, Osaka
Local Institution
Sakai
Japan, Tokyo
Local Institution
Minato-ku
Japan
Local Institution
Aomori
Japan
Local Institution
Gifu
Japan
Local Institution
Kagoshima
Japan
Local Institution
Tokyo
Japan
Local Institution
Yamagata
Korea, Republic of
Local Institution
Incheon
Korea, Republic of
Local Institution
Seodaemun-gu
Korea, Republic of
Local Institution
Seoul
Korea, Republic of
Local Institution
Seoul
Puerto Rico
Fundacion De Investigacion De Diego
San juan
Spain
Local Institution - 0040
Barcelona
Spain
Local Institution
Madrid
Spain
Local Institution
Madrid
Spain
Local Institution
Madrid
Spain
Local Institution
Malaga
Spain
Local Institution
Santander
Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo
Sevilla
Spain
Local Institution
Valencia
Spain
Local Institution
Valencia
Switzerland
Inselspital Bern-Universitätsklinik für Viszerale Chirurgie und Medizin
Bern
Switzerland
Local Institution
Lugano
Taiwan
Local Institution
Kaohsiung
Taiwan
Local Institution
Taipei
Taiwan
Local Institution
Taipei
Taiwan
Local Institution
Taoyuan
United Kingdom
Local Institution
Hull
United Kingdom
Local Institution
Liverpool
United Kingdom
Local Institution
London
United Kingdom
Local Institution
London
United Kingdom
Local Institution
Nottingham
United Kingdom
Local Institution
Southampton
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb