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Terminated NCT06121375

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

Conditions: Biliary Atresia

Sex: All

Ages: 1 Day – 18 Years

Healthy volunteers: No

Phase: PHASE2, PHASE3

Enrollment: 28

Sponsor: Intercept Pharmaceuticals

Location: Queensland Childrens Hospital South Brisbane Queensland

Summary

This study will evaluate the efficacy, safety and tolerability, as well as PK/PD of OCA in eligible pediatric participants with biliary atresia with successful hepatoportoenterostomy (HPE, also known as a Kasai portoenterostomy). The double-blind period comprises of 2 phases: dose titration phase and age expansion treatment phase.

Eligibility Criteria

Inclusion criteria: * Male or female pediatric participants from birth to \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06121375). StuddyBuddy aggregates publicly available trial information.