At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 93 enrolled
Drug / intervention
Maralixibat +1 moredrug
Likely dose
Maralixibat 600 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
MRX-502: Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC) - MARCH-PFIC
In Brief
A Phase 3 clinical trial evaluating Maralixibat and Placebo for Progressive Familial Intrahepatic Cholestasis (PFIC). Completed, enrolled 93 participants across 31 sites in 17 countries.
Detailed Summary
The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Austria, Belgium, Brazil, Canada, Colombia, France, Germany, Hungary, Italy, Lebanon, Mexico, Poland, Singapore, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartJul 2019
Primary CompletionSep 2022
TodayJul 2026
First PostedApr 5, 2019
Enrollment StartJul 9, 2019
Primary CompletionSep 1, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.2 years ago
Interventions
Maralixibatdrug
Maralixibat oral solution (up to 600 mcg/kg) orally twice daily for 26 weeks.
Placeboother
Placebo matching to maralixibat orally twice daily for 26 weeks.