Status:
COMPLETED
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
Lead Sponsor:
Intercept Pharmaceuticals
Conditions:
Compensated Cirrhosis
Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 cirrhos...
Eligibility Criteria
Inclusion
- 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:
- Current or past history of a clinically evident hepatic decompensation event, such as ascites, hepatic encephalopathy (HE), or variceal bleeding
- Current or past history of CP score ≥7 points
- Model for End-stage Liver Disease (MELD) score \> 12
- ALT ≥ 5 X ULN
- Calculated creatinine clearance \<60mL/min using Cockcroft-Gault method
- Hemoglobin A1c (HbA1c) ≥ 9.5 %
- 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)
- History of liver transplant, or current placement on a liver transplant list
Exclusion
Key Trial Info
Start Date :
August 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2022
Estimated Enrollment :
919 Patients enrolled
Trial Details
Trial ID
NCT03439254
Start Date
August 30 2017
End Date
September 8 2022
Last Update
October 23 2023
Active Locations (192)
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1
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States, 36305
2
Objective GI d/b/a North Alabama GI Research Center
Madison, Alabama, United States, 35758
3
Arizona Liver Health
Chandler, Arizona, United States, 85224
4
Arizona Liver Health
Glendale, Arizona, United States, 85306