Linerixibat Long-term Safety, and Tolerability Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Linerixibat: All participants will receive linerixibat.
Study 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.
Eligibility
Primary outcome measure(s)
- Number of participants with non-serious adverse events (AEs) and Serious AEs (SAEs) — Up to 66 months
AEs and SAEs will be collected. - Number of participants with Severe AEs — Up to 66 months
AEs and SAEs will be collected.
Trial sites (94)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Davis | California | |
| GSK Investigational Site | West Hollywood | California | |
| GSK Investigational Site | Miami | Florida | |
| GSK Investigational Site | Detroit | Michigan | |
| GSK Investigational Site | New York | New York | |
| GSK Investigational Site | Durham | North Carolina | |
| GSK Investigational Site | Morrisville | North Carolina | |
| GSK Investigational Site | Philadelphia | Pennsylvania | |
| GSK Investigational Site | Dallas | Texas | |
| GSK Investigational Site | Houston | Texas | |
| GSK Investigational Site | Seattle | Washington | |
| GSK Investigational Site | Buenos Aires | Argentina | |
| GSK Investigational Site | Capital Federal | Argentina | |
| GSK Investigational Site | Ciudad AutOnoma de Buenos Aire | Argentina | |
| GSK Investigational Site | Ciudad Autonoma de Bueno | Argentina | |
| GSK Investigational Site | Rosario | Argentina | |
| GSK Investigational Site | Santa Fe | Argentina | |
| GSK Investigational Site | Porto Alegre | Rio Grande do Sul | |
| GSK Investigational Site | Botucatu | Brazil | |
| GSK Investigational Site | Brasília | Brazil | |
| GSK Investigational Site | Salvador | Brazil | |
| GSK Investigational Site | Sofia | Bulgaria | |
| GSK Investigational Site | Edmonton | Alberta | |
| GSK Investigational Site | Toronto | Ontario | |
| GSK Investigational Site | Beijing | China | |
| GSK Investigational Site | Beijing | China | |
| GSK Investigational Site | Changchun | China | |
| GSK Investigational Site | Chongqing | China | |
| GSK Investigational Site | Guangzhou | China | |
| GSK Investigational Site | Nanchang | China | |
| GSK Investigational Site | Nanjing | China | |
| GSK Investigational Site | Shanghai | China | |
| GSK Investigational Site | Tianjin | China | |
| GSK Investigational Site | Pilsen | Czechia | |
| GSK Investigational Site | Prague | Czechia | |
| GSK Investigational Site | Lille | France | |
| GSK Investigational Site | Erlangen | Germany | |
| GSK Investigational Site | Münster | Germany | |
| GSK Investigational Site | Haifa | Israel | |
| GSK Investigational Site | Holon | Israel |
+ 54 more sites — see the full list on the official registry below.
More GlaxoSmithKline trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04167358 on ClinicalTrials.gov ↗ ← All trials in Italy