Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OCA) Compared to Placebo in Pediatric Participants With Biliary Atresia, Post-hepatoportoenterostomy

NCT06121375 · clinicaltrials.gov ↗
PHASE2,PHASE3
Phase
TERMINATED
Status
28
Enrollment
INDUSTRY
Sponsor class

Stopped Intercept made a business decision to terminate the study based on FDA's request for voluntary withdrawal of Ocaliva and the issuance of clinical hold on studies under US IND involving OCA.

Conditions

Interventions

Sponsor

Intercept Pharmaceuticals