Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
Purpose
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
Conditions
- Compensated Cirrhosis
- Nonalcoholic Steatohepatitis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the NASH CRN scoring system determined by central reading
Exclusion Criteria
- Current or past history of a clinically evident hepatic decompensation event, such as ascites, hepatic encephalopathy (HE), or variceal bleeding 2. Current or past history of CP score ≥7 points 3. Model for End-stage Liver Disease (MELD) score > 12 4. ALT ≥ 5 X ULN 5. Calculated creatinine clearance <60mL/min using Cockcroft-Gault method 6. Hemoglobin A1c (HbA1c) ≥ 9.5 % 7. Evidence of other known forms of chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC) 8. History of liver transplant, or current placement on a liver transplant list
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Obeticholic Acid (OCA) 10 mg |
10 mg OCA for up to 18 months |
|
Experimental Obeticholic Acid (OCA) 10 mg to 25 mg |
10 mg OCA for the first 3 months and then may titrate up to 25 mg OCA for the remaining 15 months of the study |
|
Placebo Comparator Placebo |
Placebo for up to 18 months |
|
More Details
- Status
- Completed
- Sponsor
- Intercept Pharmaceuticals