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



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:August 30, 2017
End Date:July 2021
Contact:Roger Davies
Email:roger.davies@interceptpharma.com
Phone:1-619-541-7249

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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

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.


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 hepatic decompensation such as clinically significant
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 ≥ 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
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