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

NCT03439254 PHASE3 COMPLETED Results posted

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.

Details

Lead sponsor	Intercept Pharmaceuticals
Phase	PHASE3
Status	COMPLETED
Enrolment	919
Start date	Wed Aug 30 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Sep 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Compensated Cirrhosis
• Nonalcoholic Steatohepatitis

Interventions

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

Countries

France, New Zealand, Ukraine, United Kingdom, Germany, Hungary, Poland, Canada, Puerto Rico, Australia, United States, Spain