Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome

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.

Timeline

Start

2013-08

Primary completion

2015-02

Completion

2015-03

Outcome

Missed primary endpoint

registry analysis (superiority or other test); LUM001 Overall vs Placebo Overall; p = 0.6954; LS mean difference from placebo -23.969 (95% CI -151.969 to 104.031); ANCOVA NCT01903460 ↗

Drugs

Indications