Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

  • Interventional
  • Recruiting
  • NCT02548351
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
All

Age Group
18 Years to 85 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         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).

         3. 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.

         4. Stable body weight.

        Exclusion Criteria:

         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
  • Nonalcoholic Steatohepatitis (NASH)

At a Glance

National Government IDNCT02548351

IRB#IRB15-1523

Lead SponsorIntercept Pharmaceuticals

Lead PhysicianKapuluru Reddy

Collaborator(s)N/A

EligibilityAll
18 Years to 85 Years
Recruiting