Summary

for people ages 18-85 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:
Rohit Loomba

Description

Summary

The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Official Title

A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis

Keywords

Non Alcoholic Steatohepatitis (NASH) Non Alcoholic Steatohepatitis, fatty liver disease, NASH Fatty Liver Non-alcoholic Fatty Liver Disease Chenodeoxycholic Acid Obeticholic Acid

Eligibility

You can join if…

Open to people ages 18-85

  1. Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by presence of all 3 key histological features of NASH according to NASH CRN criteria.
  2. Histologic evidence of fibrosis stage 2 or stage 3 as defined by the NASH CRN scoring of fibrosis, or

Histologic evidence of fibrosis stage 1a or stage 1b if accompanied by ≥1 of the following risk factors:

  • Obesity (BMI ≥30 kg/m2)
  • Type 2 diabetes diagnosed per 2013 American Diabetes Association criteria
  • ALT >1.5× upper limit of normal (ULN).
  • For subjects with a historical biopsy, is either not taking or is on stable doses of TZDs/glitazones or vitamin E for 6 months before Day 1.
  • Stable body weight.

You CAN'T join if...

  1. Model for End-stage Liver Disease (MELD) score >12
  2. ALT ≥10× ULN
  3. HbA1c >9.5%
  4. Total bilirubin >1.5 mg/dL
  5. Evidence of other known forms of known 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)
  6. History of liver transplant, or current placement on a liver transplant list
  7. Current or history of significant alcohol consumption
  8. Prior or planned ileal resection, or prior or planned bariatric surgery
  9. Histological presence of cirrhosis
  10. . History of biliary diversion
  11. . Known positivity for human immunodeficiency virus infection.
  12. . Acute cholecystitis or acute biliary obstruction.
  13. . BMI >45 kg/m2

Locations

  • University of California, San Diego accepting new patients
    La Jolla California 92093-0063 United States
  • Scripps Clinic accepting new patients
    La Jolla California 92037 United States
  • Medical Associates Research Group accepting new patients
    San Diego California 92123 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Intercept Pharmaceuticals
ID
NCT02548351
Phase
Phase 3
Lead Scientist
Rohit Loomba
Study Type
Interventional
Last Updated