CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 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.

Search/NCT02057692
NCT02057692Phase 2Completed
CompareCT.gov

The Evaluation of the Intestinal Bile Acid Transport (IBAT) Inhibitor LUM001 in the Reduction of Pruritus in Alagille Syndrome, a Cholestatic Liver Disease

Mirum Pharmaceuticals, Inc.·interventional·Posted Feb 7, 2014·Updated Mar 26, 2019

In Brief

A Phase 2 clinical trial evaluating LUM001 and Placebo for Alagille Syndrome. Completed, enrolled 37 participants across 13 sites in 2 countries.

Detailed Summary

The study is a randomized, double-blind, placebo-controlled study in children with Alagille Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on pruritus, serum bile acids, liver enzymes, and other biochemical markers in patients with ALGS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlagille Syndrome
CountriesCanada, United States
CollaboratorsChildhood Liver Disease Research and Education Network

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 7, 2014
Enrollment StartNov 24, 2014
Primary CompletionNov 16, 2016
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 12.4 years ago

Interventions

LUM001drug

LUM001 administered orally

Placebodrug

Placebo administered orally