Trials / Completed
CompletedNCT04950127
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 238 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Linerixibat | Participants will receive linerixibat. |
| DRUG | Placebo | Participants will receive placebo. |
Timeline
- Start date
- 2021-08-27
- Primary completion
- 2024-10-28
- Completion
- 2024-12-20
- First posted
- 2021-07-06
- Last updated
- 2025-07-22
- Results posted
- 2025-07-22
Locations
114 sites across 19 countries: United States, Argentina, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Greece, Israel, Italy, Japan, Mexico, Poland, Russia, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04950127. Inclusion in this directory is not an endorsement.