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

Registry ID

747-308

Source registry

HEALTH_CANADA

Status

Closed

Phase

PHASE2

Study type

INTERVENTIONAL

Sponsor

INTERCEPT PHARMACEUTICALS INC

Start date

2024-08-16

Completion date

2025-09-19

Last update

2024-02-07

Conditions

• BILIARY ATRESIA

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• A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ODEVIXIBAT (A4250) IN CHILDREN WITH BILIARY ATRESIA WHO HAVE UNDERGONE A KASAI HEPATOPORTOENTEROSTOMY

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