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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06121375
Study type Interventional
Source Intercept Pharmaceuticals
Contact Scott Birnbaum
Phone +1 6197572331
Email scott.birnbaum@interceptpharma.com
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date March 2024
Completion date December 2027

See also
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Completed NCT01854827 - Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia Phase 1/Phase 2
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Completed NCT00294684 - A Randomized, Double-Blinded, Placebo-Controlled Trial of Corticosteroid Therapy Following Portoenterostomy N/A
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