Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion
Rohit Loomba, MD, MHSc.

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 Diego (Altman Clinical and Translational Research Institute) accepting new patients
    La Jolla California 92037 United States
  • Scripps Whittier Diabetes Institute accepting new patients
    La Jolla California 92037 United States

Lead Scientist

  • Rohit Loomba, MD, MHSc.
    Adjunct Professor, Family Medicine and Public Health. Authored (or co-authored) 371 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