Linerixibat Long-term Safety, and Tolerability Study (NCT04167358)
Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: GSK Investigational Site — Davis, California
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (94 Sites)
Showing the first 25 of 94 sites.
- 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,
- 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 — Porto Alegre, Rio Grande do Sul
- GSK Investigational Site — Botucatu,
- GSK Investigational Site — Brasília,
- GSK Investigational Site — Salvador,
- GSK Investigational Site — Sofia,
- GSK Investigational Site — Edmonton, Alberta
- GSK Investigational Site — Toronto, Ontario
- GSK Investigational Site — Beijing,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.