Summary

for people ages 18-85 (full criteria)
at Fresno, California and other locations
study started
estimated completion
Mandana Khalili

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, NASHFatty LiverNon-alcoholic Fatty Liver DiseaseChenodeoxycholic AcidObeticholic 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

  • UCSF Fresno Clinical Research Centeraccepting new patients
    FresnoCalifornia93701United States
  • University of California San Francisco (UCSF) / San Francisco General Hospitalaccepting new patients
    San FranciscoCalifornia94110United States
  • University of California San Franciscoaccepting new patients
    San FranciscoCalifornia94143United States
  • California Pacific Medical Centeraccepting new patients
    San FranciscoCalifornia94115United States
  • Quest Clinical Researchaccepting new patients
    San FranciscoCalifornia94115United States
  • Fresno Clinical Research Center (FCRC)accepting new patients
    FresnoCalifornia93720United States

Lead Scientist

  • Mandana Khalili
    Co-Director, Clinical and Translational Science Institute (CTSI)-Comprehensive Mentoring Program My research focuses on natural history of chronic viral hepatitis (hepatitis B and hepatitis C), novel treatments for viral hepatitis, health services/health disparity in viral hepatitis, and evaluation of metabolic abnormalities and pathophysiology of diabetes within the context of hepatitis C and B.

Details

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