Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-27 @ 6:21 AM
Study NCT ID:
NCT01336959
Status:
TERMINATED
Last Update Posted:
2020-11-06
First Post:
2011-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery
Sponsor:
Mereo BioPharma
Organization:
Study Overview
Official Title:
A Two-part, Randomized, Double-blind, Placebo-controlled, Single Dose Study of BCT197 for the Prevention of Acute Kidney Injury (AKI) in Patients Undergoing Elective Cardiac Surgery With Cardiopulmonary Bypass (CPB)
Status:
TERMINATED
Status Verified Date:
2020-11
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:
This study will assess the safety and efficacy of BCT197 on acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-002735-25 | EUDRACT_NUMBER | None | View |