Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)
NCT ID: NCT04267393
Last Updated: 2024-09-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
124 participants
INTERVENTIONAL
2021-03-17
2024-02-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dose A BMS-986263
BMS-986263
Specified dose on specified days
Dose B BMS-986263
BMS-986263
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
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BMS-986263
Specified dose on specified days
Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Men and women must agree to follow methods of contraception
Exclusion Criteria
* 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
21 Years
75 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Arizona Clinical Trials - Tucson
Chandler, Arizona, United States
Local Institution - 0173
Chandler, Arizona, United States
The Institute for Liver Health-The Institute for Liver Health
Chandler, Arizona, United States
Local Institution
Phoenix, Arizona, United States
Local Institution - 0140
La Jolla, California, United States
Local Institution - 0205
Lancaster, California, United States
GastroIntestinal BioSciences
Los Angeles, California, United States
Local Institution - 0143
Redwood City, California, United States
Florida Research Institute
Lakewood Rch, Florida, United States
Local Institution - 0024
Leesburg, Florida, United States
Local Institution - 0061
Miami, Florida, United States
Local Institution - 0025
Winter Park, Florida, United States
Local Institution - 0121
Iowa City, Iowa, United States
Local Institution - 0150
Baltimore, Maryland, United States
Local Institution
Fall River, Massachusetts, United States
Local Institution - 0077
Kansas City, Missouri, United States
Local Institution - 0186
Omaha, Nebraska, United States
Research Foundation of SUNY - University of Buffalo
Buffalo, New York, United States
NYU Langone Health-Department of Medicine
New York, New York, United States
Local Institution
New York, New York, United States
Local Institution - 0206
Morehead City, North Carolina, United States
Local Institution - 0177
Philadelphia, Pennsylvania, United States
Local Institution - 0017
Philadelphia, Pennsylvania, United States
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, United States
Local Institution - 0171
Dallas, Texas, United States
Local Institution - 0109
Houston, Texas, United States
Local Institution
McAllen, Texas, United States
Local Institution - 0013
San Antonio, Texas, United States
Local Institution - 0122
Richmond, Virginia, United States
Local Institution - 0089
Ciudad de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0126
San Juan Bautista, Buenos Aires, Argentina
Local Institution - 0209
Quilmes, Buenos Aires F.D., Argentina
Local Institution - 0059
Buenos Aires, , Argentina
Local Institution - 0009
Edegem, , Belgium
Local Institution - 0006
Ghent, , Belgium
Local Institution - 0133
Leuven, , Belgium
Local Institution - 0083
Salvador, Estado de Bahia, Brazil
Local Institution - 0182
Bento Gonçalves, Rio Grande do Sul, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0187
Barretos, São Paulo, Brazil
Local Institution - 0188
Botucatu, São Paulo, Brazil
Local Institution
Ribeirão Preto, São Paulo, Brazil
Local Institution - 0196
São Bernardo do Campo, São Paulo, Brazil
Local Institution - 0120
São Paulo, , Brazil
Local Institution
São Paulo, , Brazil
Local Institution - 0128
Victoria, British Columbia, Canada
Local Institution - 0097
Toronto, Ontario, Canada
Local Institution - 0094
Lyon, , France
Local Institution - 0031
Nice, , France
Local Institution - 0101
Paris, , France
Local Institution - 0105
Paris, , France
Local Institution - 0137
Strasbourg, , France
Local Institution - 0029
Vandœuvre-lès-Nancy, , France
Local Institution - 0202
Créteil, Île-de-France Region, France
Local Institution - 0082
Frankfurt am Main, Hesse, Germany
Local Institution - 0091
Berlin, , Germany
Local Institution - 0099
Essen, , Germany
Local Institution - 0096
Hanover, , Germany
Local Institution - 0073
Kiel, , Germany
Local Institution - 0194
Lübeck, , Germany
Local Institution - 0071
Mainz, , Germany
Local Institution - 0060
Munich, , Germany
Local Institution - 0204
Trier, , Germany
Local Institution - 0056
Haifa, , Israel
Local Institution - 0076
Petah Tikva, , Israel
Local Institution - 0058
Ramat Gan, , Israel
Local Institution - 0057
Tel Aviv, , Israel
Local Institution - 0054
Bologna, , Italy
Azienda Ospedaliera Universitaria Di Messina G. Martino-D.A.I. Medicina Interna
Messina, , Italy
Local Institution - 0115
Palermo, , Italy
Local Institution - 0051
Pisa, , Italy
Local Institution
Rome, , Italy
Local Institution - 0200
Tōon, Ehime, Japan
Local Institution - 0048
Kurume, Fukuoka, Japan
Local Institution - 0049
Sapporo, Hokkaido, Japan
Local Institution - 0127
Shiwagun Yahabatyo, Iwate, Japan
Local Institution - 0075
Yokohama, Kanagawa, Japan
Local Institution - 0155
Matsumoto, Nagano, Japan
Local Institution - 0111
Kashihara, Nara, Japan
Local Institution - 0163
Sakai, Osaka, Japan
Local Institution - 0125
Bunkyō, Tokyo, Japan
Local Institution - 0138
Minato-ku, Tokyo, Japan
Local Institution - 0199
Aomori, , Japan
Local Institution - 0193
Gifu, , Japan
Local Institution - 0026
Hiroshima, , Japan
Local Institution - 0135
Kagoshima, , Japan
Local Institution - 0131
Kyoto, , Japan
Local Institution - 0132
Yamagata, , Japan
Local Institution - 0012
San Juan, , Puerto Rico
Local Institution - 0093
Incheon, Incheon-gwangyeoksi [Incheon], South Korea
Local Institution - 0066
Seodaemun-gu, , South Korea
Local Institution - 0090
Seoul, , South Korea
Local Institution - 0040
Barcelona, , Spain
Local Institution - 0080
Madrid, , Spain
Local Institution - 0039
Madrid, , Spain
Local Institution - 0038
Madrid, , Spain
Local Institution - 0036
Málaga, , Spain
Local Institution - 0037
Santander, , Spain
Local Institution - 0041
Seville, , Spain
Local Institution - 0035
Valencia, , Spain
Local Institution - 0043
Valencia, , Spain
Local Institution - 0102
Lugano, Canton Ticino, Switzerland
Local Institution - 0074
Bern, , Switzerland
Local Institution - 0001
Kaohsiung City, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution - 0004
Taoyuan District, , Taiwan
Local Institution - 0011
Nottingham, Nottinghamshire, United Kingdom
Local Institution - 0034
Hull, , United Kingdom
Local Institution - 0124
Liverpool, , United Kingdom
Local Institution - 0005
London, , United Kingdom
Local Institution
Southampton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
Other Identifiers
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2019-003932-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1241-4762
Identifier Type: OTHER
Identifier Source: secondary_id
IM025-017
Identifier Type: -
Identifier Source: org_study_id
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