Overview

Linerixibat Long-term Safety, and Tolerability Study

Status:
Recruiting
Trial end date:
2025-12-23
Target enrollment:
Participant gender:
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 duration of the study will be approximately four years until study end, however the total duration of study participation will vary by participant depending upon time of entry relative to study end in their respective country.
Phase:
Phase 3
Details
Lead Sponsor:
GlaxoSmithKline