Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Linerixibat Long-term Safety, and Tolerability Study
NCT04167358 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04167358
The ClinicalTrials.gov registry entry for NCT04167358 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 242 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04167358 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04167358?
The interventions under investigation include: Linerixibat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04167358?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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