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NCT04168385 · ClinicalTrials.gov registry record · Phase 2
MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study
A Phase 2 study, sponsored by Mirum Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT04168385: Completed Phase 2 study, sponsored by Mirum Pharmaceuticals.
NCT04168385 is a Phase 2 study that has completed, run by Mirum Pharmaceuticals. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04168385, a Phase 2 study, has completed, sponsored by Mirum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
Evaluate the long-term safety of maralixibat (MRX) in subjects with cholestatic liver disease including, but not limited to, Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC) and Biliary Atresia.
Primary Outcome
TEAE = Treatment-emergent Adverse Event; AESI = Adverse Event of Special Interest..
Interventions
- DRUG Maralixibat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2020-01-16 |
| Est. Completion | 2024-09-04 |
| Phase | Phase 2 |
What the finished NCT04168385 record still lists
NCT04168385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 1 intervention - of which Maralixibat is the first listed.
NCT04168385 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04168385 about?
NCT04168385 is a clinical study titled "MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study". Evaluate the long-term safety of maralixibat (MRX) in subjects with cholestatic liver disease including, but not limited to, Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC) and Biliary Atresia.
What is the current status of trial NCT04168385?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2020-01-16. Estimated completion is 2024-09-04.
What interventions are being tested in trial NCT04168385?
The interventions under investigation include: Maralixibat (DRUG).
Who is sponsoring clinical trial NCT04168385?
This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04168385's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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