Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
Completed · Phase 3 · Has a placebo group
Conditions studied: Compensated Cirrhosis, Nonalcoholic Steatohepatitis
In brief
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.
Key facts
- Study ID
- NCT03439254
- Run by
- Intercept Pharmaceuticals
- People needed
- 919
- Starts
- 2017-08-30
- Expected to finish
- 2022-09-08
- Last updated by the study team
- 2023-10-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Objective GI d/b/a North Alabama GI Research Center — Madison, Alabama, United States
- Arizona Liver Health — Chandler, Arizona, United States
- Arizona Liver Health — Glendale, Arizona, United States
- The Institute for Liver Health — Tucson, Arizona, United States
- Liver Wellness Center — Little Rock, Arkansas, United States
- Arkansas Gastroenterology — North Little Rock, Arkansas, United States
- Hope Clinical Research — Canoga Park, California, United States
- University of California, San Francisco-Fresno — Fresno, California, United States
- Scripps Whittier Diabetes Institute — La Jolla, California, United States
- eStudySite — La Mesa, California, United States
- Keck Hospital of USC — Los Angeles, California, United States
- Cedars-Sinani Medical Center — Los Angeles, California, United States
- Palmtree Clinical Research, INC. — Palm Springs, California, United States
- Stanford University Medical Center — Palo Alto, California, United States
- California Liver Research Institute — Pasadena, California, United States
- Inland Empire Liver Foundation — Rialto, California, United States
- University of California, Davis Medical Center — Sacramento, California, United States
- Kaiser Permanente Sacramento Medical Center — Sacramento, California, United States
- University of California, San Francisco — San Francisco, California, United States
- University of Colorado Denver and Hospital — Aurora, Colorado, United States
- Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
- South Denver Gastroenterology, PC — Englewood, Colorado, United States
- Innovative Medical Research of South Florida, Inc. — Aventura, Florida, United States
- Hi Tech and Global Research LLC — Coral Gables, Florida, United States
- Digestive Health Specialists of the Southeast — Dothan, Alabama, United States
Full record on ClinicalTrials.gov
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