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Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)
Sponsor: GlaxoSmithKline
Summary
This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.
Official title: A Two-part, Randomized, Placebo Controlled, Double Blind, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis (PBC)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
238
Start Date
2021-08-27
Completion Date
2024-12-20
Last Updated
2026-07-22
Healthy Volunteers
No
Conditions
Interventions
Linerixibat
Participants will receive linerixibat.
Placebo
Participants will receive placebo.
Locations (5)
GSK Investigational Site
Erlangen, Germany
GSK Investigational Site
Münster, Germany
GSK Investigational Site
Cambridge, United Kingdom
GSK Investigational Site
Durham, United Kingdom
GSK Investigational Site
Newcastle upon Tyne, United Kingdom