Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04718961
Status:
TERMINATED
Last Update Posted:
2023-02-08
First Post:
2021-01-19
Brief Title:
A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy OHANA
Sponsor:
Mirum Pharmaceuticals Inc
Organization:
Mirum Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 2a2b Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in Adult Women With Intrahepatic Cholestasis of Pregnancy and Elevated Serum Bile Acid Concentrations OHANA
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to companys assessment of enrollment feasibility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OHANA
Brief Summary:
Part 1 is an open-label randomized study of volixibat in patients with Intrahepatic Cholestasis of Pregnancy ICP and elevated serum bile acid concentrations sBA to evaluate safety and tolerability of two doses of volixibat Part 2 is a double-blind placebo controlled study designed to evaluate the safety and efficacy of a selected volixibat dose
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-003448-96 | EUDRACT_NUMBER | None | None |