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Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai

NCT04524390 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-03-19

Study results available
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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).

Conditions

  • Biliary Atresia

Interventions

DRUG

Maralixibat

A small molecule inhibitor of the ileal bile acid transporter (IBAT)

OTHER

Placebo

Identical to maralixibat except for the active drug substance

Sponsors & Collaborators

  • Mirum Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Days
Max Age
111 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-08
Primary Completion
2023-11-07
Completion
2024-02-07
FDA Drug
Yes

Countries

  • United States
  • China
  • Germany
  • Poland
  • Singapore
  • Taiwan
  • United Kingdom
  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04524390 on ClinicalTrials.gov