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Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
Recruiting
I'm InterestedTrial ID: NCT03439254
Purpose
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
Stanford Investigator(s)
Aijaz Ahmed, MD
Professor of Medicine (Gastroenterology and Hepatology)
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
Intervention(s):
drug: Obeticholic acid (10 mg)
drug: Obeticholic acid (10 mg to 25 mg)
drug: Placebo
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Angela Fuller
650-721-4326