Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

NCT02548351 · clinicaltrials.gov ↗

PHASE3

Phase

TERMINATED

Status

2477

Enrollment

INDUSTRY

Sponsor class

Stopped The FDA issued a CRL in response to Intercept's NDA for OCA for the treatment of NASH. Sponsor decided to terminate 747-303 before the planned completion date.

Conditions

Non Alcoholic Steatohepatitis (NASH)

Interventions

DRUG: Obeticholic Acid
DRUG: Placebo

Sponsor

Intercept Pharmaceuticals