Ignite Creation Date:
2024-05-06 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03347422
Status:
COMPLETED
Last Update Posted:
2022-12-23
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 Without A Recent History of Blood Transfusion
Sponsor:
Bioverativ a Sanofi company
Organization:
Sanofi
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion
Status:
COMPLETED
Status Verified Date:
2022-12
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:
Cadenza
Brief Summary:
The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to 15 grams per deciliter gdL increase in hemoglobin Hgb level and avoidance of transfusion in participants with primary cold agglutinin disease CAD without 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 primary CAD
Detailed Description:
The planned total study duration per participant was approximately 15 to 25 years
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 |
|---|---|---|---|
| BIVV009-04 | OTHER | Bioverativ Therapeutics Inc | None |
| 2017-003539-12 | EUDRACT_NUMBER | None | None |