TerminatedPhase 2/3

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

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.

Australia, Canada28 participantsStarted 2024-09-02

Plain-language 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.

Who can participate

Age range1 Day – 18 Years

SexALL

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Exclusion criteria

✕. Gastroesophageal varices and/or variceal bleeding
✕. Clinically evident ascites related to portal hypertension
✕. Hepatic encephalopathy
✕. Prior placement of portosystemic shunt
✕. Hepatopulmonary syndrome or portopulmonary hypertension
✕. Hepatorenal syndrome
✕. Any evidence of portal hypertension based on imaging (e.g., cavernous transformation of portal vein, abdominal varices, etc.)
✕. Hepatocellular carcinoma

What they're measuring

Time to the First Occurrence of Composite Endpoint

Timeframe: Up to Week 64

Trial details

NCT IDNCT06121375

SponsorIntercept Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-21

View on ClinicalTrials.gov More Biliary Atresia trials