Status:
COMPLETED
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Liver Fibrosis
Nonalcoholic Fatty Liver Disease (NAFLD)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and stage...
Eligibility Criteria
Inclusion
- Liver biopsy performed within 6 months (26 weeks) prior to the screening period. If historical biopsy is not available, a liver biopsy will be performed during the screening period. Biopsy must be consistent with NASH, with: a) a score of at least 1 for each NAS component (steatosis, lobular inflammation, and ballooning), as assessed by the central reader, and b) stage 3 liver fibrosis according to the NASH CRN classification, as assessed by the central reader
- Participants taking anti-diabetic, anti-obesity, or anti-dyslipidemic medications must have been on stable regimens for at least 3 months (12 weeks) (6 weeks for statins) prior to and during the screening period
- Participants taking vitamin E at doses greater than or equal to (\>=) 800 IU/day must have been on stable doses for at least 6 months (26 weeks) prior to and during the Screening Period. Vitamin E treatment (\>=800 IU/day) must not have been initiated after the qualifying liver biopsy was performed.
Exclusion
- Other causes of liver disease (e.g., alcoholic liver disease, hepatitis B virus infection, chronic hepatitis C virus \[HCV\] infection, autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, α-1-antitrypsin deficiency, iron overload, and hemochromatosis); participants with HCV sustained viral response (undetectable HCV RNA) for at least 2 years prior to biopsy confirming study eligibility may be eligible
- Current or past history of hepatocellular carcinoma (HCC)
- Past or current evidence of hepatic decompensation (e.g., ascites, variceal bleeding, hepatic encephalopathy and/or spontaneous bacterial peritonitis) or liver transplantation
- Other protocol defined inclusion/exclusion criteria could apply
Key Trial Info
Start Date :
June 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2021
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT03486899
Start Date
June 19 2018
End Date
August 17 2021
Last Update
September 9 2022
Active Locations (89)
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1
Local Institution - 0087
Madison, Alabama, United States, 35758
2
Local Institution - 0005
Chandler, Arizona, United States, 85224
3
Local Institution - 0088
Phoenix, Arizona, United States, 85013
4
Local Institution - 0001
Phoenix, Arizona, United States, 85054