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Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)

Primary Purpose

Nonalcoholic Steatohepatitis (NASH)

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-986263
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis (NASH) focused on measuring Nonalcoholic Steatohepatitis, Liver Disease, NASH, Compensated cirrhosis

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Clinical Trials - Tucson
  • Local Institution - 0173
  • The Institute for Liver Health-The Institute for Liver Health
  • Local Institution
  • Local Institution - 0140
  • Om Research LLC
  • GastroIntestinal BioSciences
  • Local Institution - 0143
  • Florida Research Institute
  • Local Institution - 0024
  • Local Institution - 0061
  • Clinical Site Partners - Orlando
  • Local Institution - 0121
  • Local Institution
  • Local Institution
  • Local Institution - 0077
  • Local Institution - 0186
  • Research Foundation of SUNY - University of Buffalo
  • NYU Langone Health-Department of Medicine
  • Local Institution
  • Local Institution - 0206
  • Local Institution - 0177
  • Local Institution
  • University Diabetes & Endocrine Consultants
  • Local Institution
  • Local Institution - 0109
  • Local Institution
  • Local Institution - 0013
  • Local Institution - 0122
  • Local Institution - 0089
  • Local Institution
  • Local Institution - 0209
  • Local Institution - 0059
  • Local Institution - 0009
  • Local Institution - 0006
  • Local Institution
  • Local Institution - 0083
  • Local Institution - 0182
  • Local Institution
  • Local Institution - 0187
  • Local Institution - 0188
  • Local Institution
  • Local Institution - 0120
  • Local Institution
  • Local Institution - 0128
  • Local Institution - 0097
  • Local Institution
  • Local Institution - 0101
  • Local Institution - 0105
  • Local Institution - 0137
  • Local Institution - 0202
  • Local Institution - 0082
  • Local Institution - 0091
  • Universitaetsklinikum Essen
  • Local Institution - 0096
  • Local Institution - 0073
  • Local Institution - 0194
  • Local Institution - 0071
  • Local Institution - 0060
  • Local Institution - 0204
  • Local Institution - 0056
  • Local Institution - 0076
  • Local Institution - 0058
  • Local Institution - 0057
  • Local Institution
  • Local Institution
  • A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic
  • Azienda Ospedaliera Universitaria Pisana-U.O. Epatologia
  • Local Institution
  • Local Institution - 0048
  • Local Institution - 0049
  • Local Institution - 0127
  • Local Institution - 0075
  • Local Institution - 0155
  • Local Institution - 0111
  • Local Institution - 0163
  • Local Institution - 0125
  • Local Institution - 0199
  • Local Institution - 0193
  • Local Institution - 0026
  • Local Institution - 0135
  • Local Institution - 0131
  • Local Institution - 0138
  • Local Institution - 0200
  • Local Institution - 0132
  • Local Institution - 0093
  • Local Institution - 0066
  • Local Institution - 0090
  • Local Institution - 0012
  • Local Institution - 0040
  • Local Institution - 0080
  • Local Institution
  • Local Institution - 0038
  • Local Institution - 0036
  • Local Institution - 0037
  • Local Institution - 0041
  • Local Institution
  • Local Institution - 0043
  • Local Institution - 0102
  • Local Institution - 0074
  • Local Institution - 0001
  • Local Institution
  • Local Institution
  • Local Institution - 0004
  • Local Institution - 0011
  • Local Institution - 0034
  • Local Institution
  • Local Institution - 0005
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Dose A BMS-986263

Dose B BMS-986263

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Proportion of participants who achieve ≥ 1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score)

Secondary Outcome Measures

Proportion of participants with ≥ 1 stage improvement in liver fibrosis with no increase of the NAS [NAFLD (Nonalcoholic fatty liver disease) Activity Score] by ≥ 1 point
Proportion of participants with ≥ 2 stage improvement in liver fibrosis score (NASH CRN Fibrosis Score)
Proportion of participants with ≥ 1 stage improvement in modified Ishak liver fibrosis score
Proportion of participants with ≥ 2 stage improvement in modified Ishak liver fibrosis score
Change from baseline in collagen proportionate area (CPA)
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Incidence of clinically significant changes in vital signs: Body temperature
Incidence of clinically significant changes in vital signs: Respiratory rate
Incidence of clinically significant changes in vital signs: Blood pressure
Incidence of clinically significant changes in vital signs: Heart rate
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: Mean heart rate
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
PR interval: The time from the onset of the P wave to the start of the QRS complex
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
QT interval: Measured from the beginning of the QRS complex to the end of the T wave
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcB interval
QTcB interval: Corrected QT interval using Bazett's formula (QTcB)
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Incidence of clinically significant changes in physical examination
Change from baseline in bone mineral density (BMD), as measured by dual-energy x-ray absorptiometry (DXA) scan
Plasma concentrations of components of BMS-986263 for injection

Full Information

First Posted
February 11, 2020
Last Updated
September 29, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04267393
Brief Title
Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults With Compensated Cirrhosis From Nonalcoholic Steatohepatitis (NASH)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
August 16, 2023 (Actual)
Study Completion Date
December 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis (NASH)
Keywords
Nonalcoholic Steatohepatitis, Liver Disease, NASH, Compensated cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose A BMS-986263
Arm Type
Experimental
Arm Title
Dose B BMS-986263
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-986263
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Proportion of participants who achieve ≥ 1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score)
Time Frame
At 12 weeks
Secondary Outcome Measure Information:
Title
Proportion of participants with ≥ 1 stage improvement in liver fibrosis with no increase of the NAS [NAFLD (Nonalcoholic fatty liver disease) Activity Score] by ≥ 1 point
Time Frame
At 12 weeks
Title
Proportion of participants with ≥ 2 stage improvement in liver fibrosis score (NASH CRN Fibrosis Score)
Time Frame
At 12 weeks
Title
Proportion of participants with ≥ 1 stage improvement in modified Ishak liver fibrosis score
Time Frame
At 12 weeks
Title
Proportion of participants with ≥ 2 stage improvement in modified Ishak liver fibrosis score
Time Frame
At 12 weeks
Title
Change from baseline in collagen proportionate area (CPA)
Time Frame
At 12 weeks
Title
Incidence of Adverse Events (AEs)
Time Frame
Up to week 36
Title
Incidence of Serious Adverse Events (SAEs)
Time Frame
Up to week 36
Title
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Time Frame
Up to week 36
Title
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Time Frame
Up to week 36
Title
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Time Frame
Up to week 36
Title
Incidence of clinically significant changes in vital signs: Body temperature
Time Frame
Up to week 36
Title
Incidence of clinically significant changes in vital signs: Respiratory rate
Time Frame
Up to week 36
Title
Incidence of clinically significant changes in vital signs: Blood pressure
Time Frame
Up to week 36
Title
Incidence of clinically significant changes in vital signs: Heart rate
Time Frame
Up to week 36
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: Mean heart rate
Time Frame
Up to week 36
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Description
PR interval: The time from the onset of the P wave to the start of the QRS complex
Time Frame
Up to week 36
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
Description
QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Time Frame
Up to week 36
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Description
QT interval: Measured from the beginning of the QRS complex to the end of the T wave
Time Frame
Up to week 36
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcB interval
Description
QTcB interval: Corrected QT interval using Bazett's formula (QTcB)
Time Frame
Up to week 36
Title
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
Description
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Time Frame
Up to week 36
Title
Incidence of clinically significant changes in physical examination
Time Frame
Up to week 36
Title
Change from baseline in bone mineral density (BMD), as measured by dual-energy x-ray absorptiometry (DXA) scan
Time Frame
Up to week 36
Title
Plasma concentrations of components of BMS-986263 for injection
Time Frame
Day 1 to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with liver biopsy fibrosis score stage 4 (NASH CRN) performed within 12 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Clinical Trials - Tucson
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Local Institution - 0173
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
The Institute for Liver Health-The Institute for Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Local Institution
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Local Institution - 0140
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Om Research LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
GastroIntestinal BioSciences
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Facility Name
Local Institution - 0143
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Florida Research Institute
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Facility Name
Local Institution - 0024
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Local Institution - 0061
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Clinical Site Partners - Orlando
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Local Institution - 0121
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Local Institution
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Local Institution
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Local Institution - 0077
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Local Institution - 0186
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Research Foundation of SUNY - University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
NYU Langone Health-Department of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Local Institution - 0206
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Local Institution - 0177
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Local Institution
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University Diabetes & Endocrine Consultants
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
Local Institution
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Local Institution - 0109
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution
City
McAllen
State/Province
Texas
ZIP/Postal Code
78504
Country
United States
Facility Name
Local Institution - 0013
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Local Institution - 0122
City
Richmond
State/Province
Virginia
ZIP/Postal Code
232980341
Country
United States
Facility Name
Local Institution - 0089
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1181
Country
Argentina
Facility Name
Local Institution
City
Florencio Varela
State/Province
Buenos Aires
ZIP/Postal Code
1888
Country
Argentina
Facility Name
Local Institution - 0209
City
Quilmes
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
1879
Country
Argentina
Facility Name
Local Institution - 0059
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Local Institution - 0009
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Local Institution - 0006
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution - 0083
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40110-060
Country
Brazil
Facility Name
Local Institution - 0182
City
Bento Goncalves
State/Province
RIO Grande DO SUL
ZIP/Postal Code
95700-084
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90035004
Country
Brazil
Facility Name
Local Institution - 0187
City
Barretos
State/Province
SAO Paulo
ZIP/Postal Code
14780-320
Country
Brazil
Facility Name
Local Institution - 0188
City
Botucatu
State/Province
SAO Paulo
ZIP/Postal Code
18618.687
Country
Brazil
Facility Name
Local Institution
City
Ribeirão Preto
State/Province
SAO Paulo
ZIP/Postal Code
14049900
Country
Brazil
Facility Name
Local Institution - 0120
City
Sao Paulo
ZIP/Postal Code
01.308-050
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
05652000
Country
Brazil
Facility Name
Local Institution - 0128
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3M9
Country
Canada
Facility Name
Local Institution - 0097
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Local Institution
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Local Institution - 0101
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Local Institution - 0105
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Local Institution - 0137
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Local Institution - 0202
City
Créteil
State/Province
Île-de-France
ZIP/Postal Code
94000
Country
France
Facility Name
Local Institution - 0082
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Local Institution - 0091
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Local Institution - 0096
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution - 0073
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Local Institution - 0194
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Local Institution - 0071
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Local Institution - 0060
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Local Institution - 0204
City
Trier
ZIP/Postal Code
54292
Country
Germany
Facility Name
Local Institution - 0056
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Local Institution - 0076
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Local Institution - 0058
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Local Institution - 0057
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Local Institution
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Local Institution
City
Messina
ZIP/Postal Code
98124
Country
Italy
Facility Name
A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Pisana-U.O. Epatologia
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Local Institution
City
Rome
ZIP/Postal Code
168
Country
Italy
Facility Name
Local Institution - 0048
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Local Institution - 0049
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
0608648
Country
Japan
Facility Name
Local Institution - 0127
City
Shiwagun Yahabatyo
State/Province
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Facility Name
Local Institution - 0075
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Local Institution - 0155
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
3908621
Country
Japan
Facility Name
Local Institution - 0111
City
Kashihara-shi
State/Province
Nara
ZIP/Postal Code
6348522
Country
Japan
Facility Name
Local Institution - 0163
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8025
Country
Japan
Facility Name
Local Institution - 0125
City
Bunkyō
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Local Institution - 0199
City
Aomori
ZIP/Postal Code
030-8553
Country
Japan
Facility Name
Local Institution - 0193
City
Gifu
ZIP/Postal Code
5008513
Country
Japan
Facility Name
Local Institution - 0026
City
Hiroshima
ZIP/Postal Code
7348851
Country
Japan
Facility Name
Local Institution - 0135
City
Kagoshima
ZIP/Postal Code
8908520
Country
Japan
Facility Name
Local Institution - 0131
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Local Institution - 0138
City
Minato-ku
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Local Institution - 0200
City
Toon
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Local Institution - 0132
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
Local Institution - 0093
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Local Institution - 0066
City
Seodaemun-gu
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Local Institution - 0090
City
Seoul
ZIP/Postal Code
04401
Country
Korea, Republic of
Facility Name
Local Institution - 0012
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Local Institution - 0040
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0080
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Local Institution - 0038
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Local Institution - 0036
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution - 0037
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Local Institution - 0041
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Local Institution - 0043
City
València
ZIP/Postal Code
46026
Country
Spain
Facility Name
Local Institution - 0102
City
Lugano
State/Province
Ticino
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Local Institution - 0074
City
Berne
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Local Institution - 0001
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Local Institution - 0004
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Local Institution - 0011
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Local Institution - 0034
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Local Institution
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Local Institution - 0005
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Local Institution
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)

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