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NCT06553768 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)
A Phase 3 study of Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC), sponsored by Mirum Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT06553768: Recruiting Phase 3 study of Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC), sponsored by Mirum Pharmaceuticals.
NCT06553768 is a Phase 3 study of Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC) that is actively recruiting participants, run by Mirum Pharmaceuticals. The registered enrollment target is 90 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06553768, a Phase 3 study of Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC), is actively recruiting participants, sponsored by Mirum Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric and adult participants who have cholestatic liver disease with pruritus that has been refractory to other therapies, and who have no other treatment options.
Primary Outcome
ItchRO(Obs) severity score = Itch Reported Outcome Observer assessment severity score; scale between 0 (not itchy at all) and 4 (extremely itchy); the lower the score the better.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Maralixibat
Study Locations (20)
Other
- Hospital de Criança de Brasília (HCB) - Brasília
- Hospital da Criança Santo Antonio - Porto Alegre
- Hospital Sírio-Libanês - São Paulo
- Hôpital Femme Mère Enfant - Lyon
- Hôpitaux Universitaires de Marseille Timone - Marseille
New York
- NYU Langone Health - New York
- Mount Sinai Hospital - New York
- Morgan Stanley Children's Hospital - NewYork Presbyterian - New York
California
- Children's Hospital Los Angeles (CHLA) - Los Angeles
- Stanford Children's Health in Palo Alto - Palo Alto
Illinois
- Lurie Children's Hospital - Chicago
Louisiana
- Ochsner Clinic Foundation - New Orleans
North Carolina
- Science 37, Inc (Remote-homebase Telemedicine) - Morrisville
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2024-10-14 |
| Est. Completion | 2027-02 |
| Phase | Phase 3 |
What NCT06553768 shows while recruiting
NCT06553768 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06553768 names 20 study sites across 13 states, led by Other, New York, California.
Frequently Asked Questions
What is clinical trial NCT06553768 about?
NCT06553768 is a clinical study titled "Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)". The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric and adult participants who have cholestatic liver disease with pruritus that has been refractory to other therapies, and who have no other treatment options.
What is the current status of trial NCT06553768?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2024-10-14. Estimated completion is 2027-02.
What conditions does trial NCT06553768 study?
This clinical trial studies the following conditions: Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC).
What interventions are being tested in trial NCT06553768?
The interventions under investigation include: Placebo (OTHER), Maralixibat (DRUG).
Who is sponsoring clinical trial NCT06553768?
This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06553768 being conducted?
This trial has 20 study locations across California, Illinois, Louisiana, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06553768's enrollment target sits among peer trials
90 1725th of 2000 higher than 263 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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