At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 20 enrolled
Drug / intervention
LUM001 +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.
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Paediatric Patients With Alagille Syndrome
In Brief
A Phase 2 clinical trial evaluating LUM001 and Placebo for Alagille Syndrome. Completed, enrolled 20 participants across 3 sites.
Detailed Summary
The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus placebo on the biochemical markers and pruritus associated with Alagille Syndrome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlagille Syndrome
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 2013
Enrollment StartAug 2013
Primary CompletionFeb 2015
Study CompletionMar 2015
TodayJul 2026
First PostedJul 19, 2013
Enrollment StartAug 1, 2013
Primary CompletionFeb 1, 2015
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 13.0 years ago
Interventions
LUM001drug
Placebodrug