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NCT04185363 · ClinicalTrials.gov registry record · Phase 3
An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
A Phase 3 study of Progressive Familial Intrahepatic Cholestasis (PFIC), sponsored by Mirum Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT04185363 is a Phase 3 study of Progressive Familial Intrahepatic Cholestasis (PFIC) that has completed, run by Mirum Pharmaceuticals. The registered enrollment target is 90 participants. The trial reports 20 study locations across 11 states.
The verdict
NCT04185363, a Phase 3 study of Progressive Familial Intrahepatic Cholestasis (PFIC), has completed, sponsored by Mirum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this open label extension study is to evaluate the long-term safety and tolerability of maralixibat.
Conditions Studied
Interventions
- DRUG Maralixibat
Study Locations (20)
Other
- Hospital Italiano de Buenos Aires - Buenos Aires
- Medizinische Universität Wien, Universitätsklinik für Kinder- und Jugendheilkunde - Vienna
- Cliniques Universitaires Saint-Luc - Brussels
- Sociedade Beneficente de Senhoras Hospital Sírio-Libanês - São Paulo
- Fundacion Cardioinfantil - Bogotá
- Groupement Hospitalier Est Hopital, Femme Mère Enfant de Lyon - Lyon
- CHU de Toulouse - Hôpital des Enfants - Toulouse
- Medizinische Hochschule - Hanover
- Azienda Ospedaliera Papa Giovanni XXIII - Unita di Pediatria - Bergamo
Texas
- University of Texas Southwestern Medical Center - Dallas
- University of Texas, Health Science Center San Antonio - San Antonio
California
- Children's Hospital Los Angeles - Los Angeles
District of Columbia
- Medstar Georgetown University Hospital - Washington D.C.
Florida
- Advent Health - Orlando
New York
- Children's Hospital at Montefiore - The Bronx
Ohio
- Cincinnati Children's Hospital - Cincinnati
Pennsylvania
- Children Hospital of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2020-01-08 |
| Est. Completion | 2025-04-23 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04185363
The ClinicalTrials.gov registry entry for NCT04185363 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mirum Pharmaceuticals, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Progressive Familial Intrahepatic Cholestasis (PFIC) appearing as the primary indexed condition, and to 1 intervention - of which Maralixibat is the first listed.
NCT04185363 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Texas, California.
Frequently Asked Questions
What is clinical trial NCT04185363 about?
NCT04185363 is a clinical study titled "An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)". The primary objective of this open label extension study is to evaluate the long-term safety and tolerability of maralixibat.
What is the current status of trial NCT04185363?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2020-01-08. Estimated completion is 2025-04-23.
What conditions does trial NCT04185363 study?
This clinical trial studies the following conditions: Progressive Familial Intrahepatic Cholestasis (PFIC).
What interventions are being tested in trial NCT04185363?
The interventions under investigation include: Maralixibat (DRUG).
Who is sponsoring clinical trial NCT04185363?
This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04185363 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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