drugset / Trial / NCT04524390

Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai

NCT04524390 ↗

Phase 2 Completed 75 enrolled Mirum Pharmaceuticals, Inc.
RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start
2021-07-08
Primary completion
2023-11-07
Completion
2024-02-07

Outcome

Missed primary endpoint

registry p = 0.7419; Least-Square mean -0.39 (95% CI -2.76 to 1.97); MMRM NCT04524390 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Maralixibat Small molecule — —

Indications