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NCT02057718 · ClinicalTrials.gov registry record · Phase 2
Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 (Maralixibat) in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis
A Phase 2 study of Progressive Familial Intrahepatic Cholestasis (PFIC), sponsored by Mirum Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 10
- Study locations
NCT02057718 is a Phase 2 study of Progressive Familial Intrahepatic Cholestasis (PFIC) that has completed, run by Mirum Pharmaceuticals. The registered enrollment target is 33 participants. The trial reports 10 study locations across 6 states.
The verdict
NCT02057718, a Phase 2 study of Progressive Familial Intrahepatic Cholestasis (PFIC), has completed, sponsored by Mirum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is an open label study in children with Progressive Familial Intrahepatic Cholestasis (PFIC) designed to evaluate the safety and efficacy of LUM001, also known as Maralixibat (MRX). Efficacy will be assessed by evaluating the effect of LUM001 on pruritus and the biochemical markers of pruritus associated with PFIC.
Conditions Studied
Interventions
- DRUG LUM001 (Maralixibat)
Study Locations (10)
Other
- Hopital Femme Mere Enfant De Lyon - Bron
- The Children's Memorial Health Institute - Warsaw
- Leeds Teaching Hospital NHS Trust - Leeds
- Kings College Hospital - London
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
California
- Children's Hospital Los Angeles - Los Angeles
Colorado
- Children's Hospital Colorado - Aurora
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
West Midlands
- Birmingham Children's Hospital - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2014-03-01 |
| Est. Completion | 2020-05-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02057718
The ClinicalTrials.gov registry entry for NCT02057718 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 33 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 LUM001 (Maralixibat) is the first listed.
NCT02057718 reports 10 study locations spanning 6 distinct geographic areas - top geographies include Other, Pennsylvania, California.
Frequently Asked Questions
What is clinical trial NCT02057718 about?
NCT02057718 is a clinical study titled "Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 (Maralixibat) in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis". This is an open label study in children with Progressive Familial Intrahepatic Cholestasis (PFIC) designed to evaluate the safety and efficacy of LUM001, also known as Maralixibat (MRX). Efficacy will be assessed by evaluating the effect of LUM001 on pruritus and the biochemical markers of pruritus ...
What is the current status of trial NCT02057718?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2014-03-01. Estimated completion is 2020-05-08.
What conditions does trial NCT02057718 study?
This clinical trial studies the following conditions: Progressive Familial Intrahepatic Cholestasis (PFIC).
What interventions are being tested in trial NCT02057718?
The interventions under investigation include: LUM001 (Maralixibat) (DRUG).
Who is sponsoring clinical trial NCT02057718?
This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02057718 being conducted?
This trial has 10 study locations across California, Colorado, Ohio, Pennsylvania, West Midlands. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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