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Completed Phase 2 Interventional Results available

Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai

ClinicalTrials.gov ID: NCT04524390

Public ClinicalTrials.gov record NCT04524390. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jun 26, 2026, 7:12 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Study identification

NCT ID
NCT04524390
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Enrollment
75 participants

Conditions and interventions

Interventions

  • Maralixibat Drug
  • Placebo Other

Drug · Other

Eligibility (public fields only)

Age range
21 Days to 111 Days
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 7, 2021
Primary completion
Nov 6, 2023
Completion
Feb 6, 2024
Last update posted
Mar 18, 2025

2021 – 2024

United States locations

U.S. sites
7
U.S. states
5
U.S. cities
6
Facility City State ZIP Site status
Phoenix Children's Division of Gastroenterology & Hepatology Phoenix Arizona 85016
Children's Healthcare of Atlanta - Emory University School of Medicine Atlanta Georgia 30329
NYU Grossman School of Medicine New York New York 10016
New York-Presbyterian - Columbia University Medical Center New York New York 10032
Montefiore Medical Center The Bronx New York 10467
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
Texas Children's Hospital Houston Texas 77030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04524390, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 18, 2025 · Synced Jun 26, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04524390 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →