Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427395
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-09
Brief Title:
Open-Label Extension Study of Saroglitazar Magnesium in Participants with Primary Biliary Cholangitis
Sponsor:
Zydus Therapeutics Inc
Organization:
Zydus Therapeutics Inc
Study Overview
Official Title:
A Multicenter Open-Label Extension Clinical Trial to Evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants with Primary Biliary Cholangitis PBC
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
Detailed Description:
A Multicenter Open-Label Extension Clinical trial to evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants with Primary Biliary Cholangitis PBC
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