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NCT04167358 · ClinicalTrials.gov registry record · Phase 3
Linerixibat Long-term Safety, and Tolerability Study
A Phase 3 study of Cholestasis, sponsored by GlaxoSmithKline.
- Active
- Registry status
- Phase 3
- Development phase
- 242
- Enrollment target
- 20
- Study locations
NCT04167358: Active Phase 3 study of Cholestasis, sponsored by GlaxoSmithKline.
NCT04167358 is a Phase 3 study of Cholestasis that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 242 participants, above the 117-participant average among 6 other Cholestasis trials with a reported enrollment target (107% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04167358, a Phase 3 study of Cholestasis, is active but no longer recruiting, sponsored by GlaxoSmithKline.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 242 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
AEs and SAEs will be collected.
Conditions Studied
Interventions
- DRUG Linerixibat
Study Locations (20)
Other
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - Capital Federal
- GSK Investigational Site - Ciudad AutOnoma de Buenos Aire
- GSK Investigational Site - Ciudad Autonoma de Bueno
- GSK Investigational Site - Rosario
- GSK Investigational Site - Santa Fe
- GSK Investigational Site - Botucatu
- GSK Investigational Site - Brasília
California
- GSK Investigational Site - Davis
- GSK Investigational Site - West Hollywood
North Carolina
- GSK Investigational Site - Durham
- GSK Investigational Site - Morrisville
Texas
- GSK Investigational Site - Dallas
- GSK Investigational Site - Houston
Florida
- GSK Investigational Site - Miami
Michigan
- GSK Investigational Site - Detroit
New York
- GSK Investigational Site - New York
Pennsylvania
- GSK Investigational Site - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2020-07-14 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 3 |
What the registry record for NCT04167358 still lists
NCT04167358 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, above the 117-participant average among 6 other Cholestasis trials with a reported enrollment target (107% higher).
The record links to 1 condition, with Cholestasis appearing as the primary indexed condition, and to 1 intervention - of which Linerixibat is the first listed.
NCT04167358 names 20 study sites across 10 states, led by Other, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT04167358 about?
NCT04167358 is a clinical study titled "Linerixibat Long-term Safety, and Tolerability Study". 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 \[NCT0189970...
What is the current status of trial NCT04167358?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 242 participants. The study started on 2020-07-14. Estimated completion is 2026-09-30.
What conditions does trial NCT04167358 study?
This clinical trial studies the following conditions: Cholestasis.
What interventions are being tested in trial NCT04167358?
The interventions under investigation include: Linerixibat (DRUG).
Who is sponsoring clinical trial NCT04167358?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04167358 being conducted?
This trial has 20 study locations across California, Florida, Michigan, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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