Clinical Trial: An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Multicentre Extension Study to Evaluate the Long-Term Safety and Durability of the Therapeutic Effect of LUM001, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment
Brief Summary: The purpose of this extension study is to determine the long-term safety and tolerability of an investigational treatment (LUM001) in children with ALGS who have completed participation in the LUM001-302 study.
Detailed Summary:
Sponsor: Shire
Current Primary Outcome: Safety and tolerability [ Time Frame: 72 weeks ]
Original Primary Outcome: Safety and tolerability [ Time Frame: 48 weeks ]
Current Secondary Outcome: Efficacy [ Time Frame: 72 weeks ]
Original Secondary Outcome: Efficacy [ Time Frame: 48 weeks ]
Information By: Shire
Dates:
Date Received: January 23, 2014
Date Started: December 2013
Date Completion: August 2017
Last Updated: January 19, 2017
Last Verified: January 2017