At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 31 enrolled
Drug / intervention
LUM001 (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.
Long-Term, Open-Label Study With a Double-Blind, Placebo-Controlled, Randomized Drug Withdrawal Period of LUM001 (Maralixibat), an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Alagille Syndrome
In Brief
A Phase 2 clinical trial evaluating LUM001 (Maralixibat) and Placebo for Alagille Syndrome. Completed, enrolled 31 participants across 9 sites in 6 countries.
Detailed Summary
This is a long-term, open-label study with a double-blind, placebo-controlled, randomized drug withdrawal period in children with Alagille Syndrome (ALGS) designed to evaluate the safety and efficacy of LUM001 (Also known as maralixibat or MRX).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlagille Syndrome
CountriesAustralia, Belgium, France, Poland, Spain, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2014
Enrollment StartOct 2014
Primary CompletionMay 2020
TodayJul 2026
First PostedJun 11, 2014
Enrollment StartOct 28, 2014
Primary CompletionMay 28, 2020
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 12.1 years ago
Interventions
LUM001 (Maralixibat)drug
LUM001, also known as Maralixibat (MRX) will be administered orally Once Daily (OD). To be administered Twice Daily (BID) for patients who are eligible.
Placebodrug
Placebo will be administered orally once daily during randomized withdrawal period