NL-OMON53971
Withdrawn
Phase 2
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) - IM025-017
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 6
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\*Male and female participants, ages \>\= 21 years to \<\= 75 years of age, inclusive,
- •at the time of screening;
- •\*Liver biopsy performed within 12 months prior to the screening visit or
- •performed during the screening period. A liver biopsy performed prior to
- •informed consent form, if utilized for eligibility, must be available for
- •central pathology reading prior to Randomization.
- •i) Liver biopsy consistent with NASH Clinical Research Network (CRN)
- •Score Stage 4, as assessed by central pathology reading.
- •ii) Liver biopsy must either be consistent with steatohepatitis, as
- •assessed by central
Exclusion Criteria
- •\*Other active causes of liver disease (eg, alcoholic liver disease, hepatitis B
- •virus infection, chronic hepatitis C virus infection, autoimmune hepatitis,
- •primary biliary cholangitis, primary sclerosing cholangitis, drug\-induced
- •hepatotoxicity, Wilson disease, homozygous a\-1\-
- •antitrypsin deficiency, iron overload \[with blood iron saturation \> 50%], or
- •hemochromatosis)
- •\* Past or current evidence of hepatic decompensation (eg, ascites, variceal
- •bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis)
- •\* Liver transplantation (past or planned)
- •\* Child\-Pugh Score \> 6 at screening. Participants with a Child\-Pugh Score \> 6
Outcomes
Primary Outcomes
Not specified
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