At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 75 enrolled
Drug / intervention
Maralixibat +1 moredrug
Likely dose
Not stated in 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.
Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Subjects With Biliary Atresia After Hepatoportoenterostomy
In Brief
A Phase 2 clinical trial evaluating Maralixibat and Placebo for Biliary Atresia. Completed, enrolled 75 participants across 22 sites in 8 countries.
Detailed Summary
A study to evaluate the efficacy and safety of maralixibat in infants with Biliary Atresia (BA) after Hepatoportoenterostomy (HPE, also known as the Kasai procedure).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiliary Atresia
CountriesChina, Germany, Poland, Singapore, Taiwan, United Kingdom, United States, Vietnam
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedAug 2020
Enrollment StartJul 2021
Primary CompletionNov 2023
Study CompletionFeb 2024
TodayJul 2026
First PostedAug 24, 2020
Enrollment StartJul 8, 2021
Primary CompletionNov 7, 2023
Study CompletionFeb 7, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.9 years ago
Interventions
Maralixibatdrug
A small molecule inhibitor of the ileal bile acid transporter (IBAT)
Placeboother
Identical to maralixibat except for the active drug substance