Ignite Creation Date:
2024-05-06 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05050136
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2021-09-09
Brief Title:
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
Sponsor:
Mirum Pharmaceuticals Inc
Organization:
Mirum Pharmaceuticals Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Biliary Cholangitis
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VANTAGE
Brief Summary:
The purpose of this clinical research study is to learn more about the use of the study medicine volixibat for the treatment of pruritus itching associated with Primary Biliary Cholangitis PBC and to assess the possible impact on the disease progression of PBC
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