Overview

Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

Status:
Active, not recruiting

Trial end date:
2022-08-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Intercept Pharmaceuticals

Treatments:

Chenodeoxycholic Acid

Criteria

Key inclusion criteria:

1. Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the
NASH CRN scoring system determined by central reading

Key exclusion criteria:

1. 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