Trial Search Results

Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Intercept Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: Obeticholic acid (10 mg)
  • Drug: Obeticholic acid (10 mg to 25 mg)
  • Drug: Placebo

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Angela Fuller
650-721-4326
Recruiting