Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247735
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-22
Brief Title:
Study to Evaluate the Efficacy and Safety of K-808 Pemafibrate in Participants with Primary Biliary Cholangitis PBC with Inadequate Response to Ursodeoxycholic Acid UDCA Andor Obeticholic Acid OCA Treatment
Sponsor:
Kowa Research Institute Inc
Organization:
Kowa Research Institute Inc
Study Overview
Official Title:
A Phase 2 Randomized Placebo-controlled Parallel Group Multicenter 12-week Study with a 52-week Extension to Evaluate the Efficacy and Safety of Two Doses of K-808 Pemafibrate in Subjects with Primary Biliary Cholangitis with Inadequate Response to Ursodeoxycholic Acid Andor Obeticholic Acid Treatment
Status:
RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
Study to investigate the efficacy and safety of two doses of K-808 pemafribate in subjects with 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