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Linerixibat Long-term Safety, and Tolerability Study — LLSAT  

Cholestasis Clinical Trial

Official title:
Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis

Clinical Trial Summary

This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 [NCT01899703], 201000 GLIMMER [NCT02966834] (group 1) or 212620 GLISTEN [NCT00210418]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study's end or until linerixibat can be lawfully made available to participants. However, the total duration of study participation will vary by participant depending upon the time of entry relative to study end in their respective country.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04167358
Study type Interventional
Source GlaxoSmithKline
Contact US GSK Clinical Trials Call Center
Phone 877-379-3718
Email GSKClinicalSupportHD@gsk.com
Status Recruiting
Phase Phase 3
Start date July 14, 2020
Completion date February 2, 2027
View Details
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