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

a study on Cirrhosis Steatohepatitis

Summary

for people ages 18 years and up (full criteria)
at Fresno, California and other locations
study started
estimated completion
Marina Roytman, MDBilal Hameed, MD

Description

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.

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

Keywords

Compensated Cirrhosis Nonalcoholic Steatohepatitis Fatty Liver Disease NASH Liver Cirrhosis Fatty Liver Non-alcoholic Fatty Liver Disease Fibrosis Chenodeoxycholic Acid Obeticholic acid (10 mg) Obeticholic acid (10 mg to 25 mg) Obeticholic Acid (OCA) 10 mg Obeticholic Acid (OCA) 10 mg to 25 mg

Eligibility

For people ages 18 years and up

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

Locations

  • University of California, San Francisco-Fresno accepting new patients
    Fresno California 93701 United States
  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientists

  • Marina Roytman, MD
    Marina Roytman, M.D., FACP, is board certified in Internal Medicine and fellowship trained in Medical Education. Her interests include viral hepatitis, drug induced liver injury, autoimmune hepatitis, and medical education. She has won multiple awards for her presentations on hepatitis and drug induced liver injury.
  • Bilal Hameed, MD
    Associate Professor, Medicine. Authored (or co-authored) 37 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Intercept Pharmaceuticals
ID
NCT03439254
Phase
Phase 3
Study Type
Interventional
Last Updated