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Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai — EMBARK  

Biliary Atresia Clinical Trial

Official title:
Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Subjects With Biliary Atresia After Hepatoportoenterostomy

Clinical Trial Summary

A study to evaluate the efficacy and safety of maralixibat in infants with Biliary Atresia (BA) after Hepatoportoenterostomy (HPE, also known as the Kasai procedure).

Clinical Trial Description

This is a double-blind randomized, placebo-controlled study in subjects with Biliary Atresia with a primary endpoint at Week 26 followed by long-term open-label period during which all subjects will receive maralixibat to Week 104. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04524390
Study type Interventional
Source Mirum Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 2
Start date July 8, 2021
Completion date February 7, 2024
View Details
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