Ignite Creation Date:
2024-05-06 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03347396
Status:
COMPLETED
Last Update Posted:
2022-10-31
First Post:
2017-11-16
Brief Title:
A Study to Assess the Efficacy and Safety of BIVV009 Sutimlimab in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion Cardinal Study
Sponsor:
Bioverativ a Sanofi company
Organization:
Sanofi
Study Overview
Official Title:
A Phase 3 Pivotal Open-label Multicenter Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion
Status:
COMPLETED
Status Verified Date:
2022-10
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:
The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to 2 grams per deciliter gdL increase in hemoglobin Hgb levels or increased Hgb to 12 gdL and obviated the need for blood transfusion during treatment in participants with primary cold agglutinin disease CAD who had a recent history of blood transfusion The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with CAD
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 |
|---|---|---|---|
| BIVV009-03 | OTHER | None | None |
| 2017-003538-10 | EUDRACT_NUMBER | Bioverativ Therapeutics Inc | None |