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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Efficacy [ Time Frame: 13 weeks ]
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