Ignite Creation Date:
2024-05-06 @ 2:16 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04269551
Status:
COMPLETED
Last Update Posted:
2022-05-02
First Post:
2020-01-29
Brief Title:
A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease
Sponsor:
Bioverativ a Sanofi company
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Phase 1b Open Label Nonrandomized Single Dose Study Evaluating the Safety Tolerability and Activity of BIVV020 in Adults With Cold Agglutinin Disease
Status:
COMPLETED
Status Verified Date:
2022-04
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:
Primary Objective
To assess the safety and tolerability in participants with cold agglutinin disease CAD after a single dose of intravenous IV BIVV020
Secondary Objectives
To assess in participants with cold agglutinin disease after a single dose of intravenous IV BIVV020
The effect of BIVV020 on complement mediated hemolysis
The pharmacodynamics PD of BIVV020 relating to complement inhibition
The pharmacokinetics PK of BIVV020
The immunogenicity of BIVV020
To assess the safety and tolerability in participants with cold agglutinin disease CAD after a single dose of intravenous IV BIVV020
Secondary Objectives
To assess in participants with cold agglutinin disease after a single dose of intravenous IV BIVV020
The effect of BIVV020 on complement mediated hemolysis
The pharmacodynamics PD of BIVV020 relating to complement inhibition
The pharmacokinetics PK of BIVV020
The immunogenicity of BIVV020
Detailed Description:
Up to 23 weeks screening period up to 8 weeks treatment period 15 weeks
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 |
|---|---|---|---|
| U1111-1233-0831 | OTHER | UTN | None |
| 2019-001844-22 | EUDRACT_NUMBER | None | None |