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Study identifier: NCT06121375 Synced from ClinicalTrials.gov · August 06, 2026
● Study status: Terminated

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

Condition: Biliary Atresia  ·  Sponsor: Intercept Pharmaceuticals

PhasePhase 2/Phase 3
Planned participants28
Who can joinAll sexes, 1 Day to 18 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

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Locations (24)

Queensland Childrens HospitalSouth Brisbane, Queensland, Australia
Women's and Children's HospitalNorth Adelaide, South Australia, Australia
Royal Childrens HospitalParkville, Victoria, Australia
Alberta Childrens HospitalCalgary, Alberta, Canada
Stollery Children's HospitalEdmonton, Alberta, Canada
Children's Hospital, Zhejiang University School of MedicineHangzhou, Zhejiang, China
Guangzhou Women And Childrens Medical CenterGuangzhou, China
Children's Hospital of Fudan UniversityShanghai, China
Childrens Hospital of ShanghaiShanghai, China
Children's Hospital of ShanxiTaiyuan, China
Queen Mary HospitalHong Kong, Hong Kong
Hadassah Medical CenterJerusalem, Israel

+ 12 more locations — full list on the registry record.

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