NCT03439254

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

Official Title:

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

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.

Eligibility

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

Disease(s) and\or Condition(s)

Compensated Cirrhosis

Nonalcoholic Steatohepatitis

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: Obeticholic acid (10 mg)
    • Description: Tablets administered orally once daily.
    • Arm Group Labels: Obeticholic Acid (OCA) 10 mg
    • Type: DRUG
    • Name: Obeticholic acid (10 mg to 25 mg)
    • Description: Tablets administered orally once daily.
    • Arm Group Labels: Obeticholic Acid (OCA) 10 mg to 25 mg
    • Type: DRUG
    • Name: Placebo
    • Description: Tablets administered orally once daily.
    • Arm Group Labels: Placebo
Sponsor
  • Intercept Pharmaceuticals