Ignite Creation Date:
2024-05-06 @ 4:20 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04950127
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2021-06-25
Brief Title:
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis PBC GLISTEN
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT05448170
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None