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Clinical trial

A Randomized, Double-blind, Placebo-controlled, Phase 2/3 Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Obeticholic Acid Compared to Placebo in Pediatric Subjects With Biliary Atresia, Post-hepatoportoenterostomy

NCT06121375 is registered in ClinicalTrials.gov with Intercept Pharmaceuticals as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Double-blind, Placebo-controlled, Phase 2/3 Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Obeticholic Acid Compared to Placebo in Pediatric Subjects With Biliary Atresia, Post-hepatoportoenterostomy
Lead sponsor
Intercept Pharmaceuticals
Phase
Phase 2/3
Overall status
Terminated
Start date
September 2, 2024
Completion date
October 21, 2025
Enrollment
28 (actual)
Sites
24

Conditions

As the registry lists them; a condition with its own page is linked.