Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553768
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease EXPAND
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Participants With Cholestatic Pruritus
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether the investigational treatment maralixibat is safe and effective in pediatric and adult participants who have cholestatic liver disease with pruritus that has been refractory to other therapies and who have no other treatment options
Detailed Description:
This study will be conducted in multiple sites in North America Europe Middle East and South America
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None