Ignite Creation Date:
2024-07-17 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488911
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
Sponsor:
Intercept Pharmaceuticals
Organization:
Intercept Pharmaceuticals
Study Overview
Official Title:
A Phase 3 Open-Label Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects With Primary Biliary Cholangitis
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
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:
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination FDC of Obeticholic Acid OCA and Bezafibrate BZF tablet in Subjects with Primary Biliary Cholangitis 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