Clinical Trial: Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Shire

Current Primary Outcome: Efficacy [ Time Frame: 13 weeks ]

Change in pruritus compared to placebo from baseline to Week 13


Original Primary Outcome: Same as current

Current Secondary Outcome: Efficacy [ Time Frame: 13 weeks ]

Change in fasting serum bile acids and liver enzymes compared to placebo from baseline to Week 13


Original Secondary Outcome: Same as current

Information By: Shire

Dates:
Date Received: February 5, 2014
Date Started: November 2014
Date Completion:
Last Updated: January 13, 2017
Last Verified: January 2017