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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 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. The trial reports 20 study locations across 13 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06553768
The ClinicalTrials.gov registry entry for NCT06553768 describes a study currently listed as recruiting, 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 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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.
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