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Completed Phase 3 Interventional Results available

An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)

ClinicalTrials.gov ID: NCT04185363

Public ClinicalTrials.gov record NCT04185363. 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 Jul 22, 2026, 3:13 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

An Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Maralixibat in the Treatment of Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)

Study identification

NCT ID
NCT04185363
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Enrollment
84 participants

Conditions and interventions

Interventions

  • Maralixibat Drug

Drug

Eligibility (public fields only)

Age range
1 Year to 18 Years
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
Jan 7, 2020
Primary completion
Apr 22, 2025
Completion
Apr 22, 2025
Last update posted
Jun 22, 2026

2020 – 2025

United States locations

U.S. sites
10
U.S. states
9
U.S. cities
10
Facility City State ZIP Site status
Children's Hospital Los Angeles Los Angeles California 90027
Medstar Georgetown University Hospital Washington D.C. District of Columbia 20007
Advent Health Orlando Florida 32803
Children's Hospital at Montefiore The Bronx New York 10461
Cincinnati Children's Hospital Cincinnati Ohio 45229
Children Hospital of Pittsburgh Pittsburgh Pennsylvania 15224
Medical University of South Carolina Charleston South Carolina 29425
University of Texas Southwestern Medical Center Dallas Texas 75390
University of Texas, Health Science Center San Antonio San Antonio Texas 78229
Seattle Children's Hospital Seattle Washington 98105

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 18 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04185363, 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 Jun 22, 2026 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04185363 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →