Summary

for people ages 18 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion
Souvik Sarkar, 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 Fibrosis Liver Cirrhosis Fatty Liver Non-alcoholic Fatty Liver Disease 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 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

Locations

  • University of California, Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Kaiser Permanente Sacramento Medical Center not yet accepting patients
    Sacramento California 95825 United States

Lead Scientist

  • Souvik Sarkar, MD
    Assistant Professor, Gastroenterology and Hepatology. Authored (or co-authored) 19 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Intercept Pharmaceuticals
Links
Sign up for this study
ID
NCT03439254
Phase
Phase 3
Study Type
Interventional
Last Updated