At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 52 enrolled
Drug / intervention
Maralixibatdrug
Likely dose
Maralixibat 1140 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-800: A Long-Term Safety Study of Maralixibat, an Apical Sodium Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study
In Brief
A Phase 2 clinical trial evaluating Maralixibat for Cholestatic Liver Disease. Completed, enrolled 52 participants across 17 sites in 8 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCholestatic Liver Disease
CountriesAustralia, Belgium, Canada, France, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedNov 2019
Enrollment StartJan 2020
Primary CompletionSep 2024
TodayJul 2026
First PostedNov 19, 2019
Enrollment StartJan 16, 2020
Primary CompletionSep 4, 2024
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 6.6 years ago
Interventions
Maralixibatdrug
Maralixibat chloride oral solution orally twice daily (up to 1200\* mcg/kg/day), and according to indication. \*equivalent to 1140 mcg/kg/day maralixibat