Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04770935
Status:
COMPLETED
Last Update Posted:
2023-04-28
First Post:
2021-02-22
Brief Title:
To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa BIVV001in Adults With Type 2N and 3 Von Willebrand Disease VWD
Sponsor:
Bioverativ a Sanofi company
Organization:
Sanofi
Study Overview
Official Title:
A Phase 1 Open-Label Study to Assess the Pharmacokinetics and Safety and Tolerability of a Single Intravenous Injection of rFVIIIFc-VWF-XTEN BIVV001 in Adults With Type 2N and 3 Von Willebrand Disease VWD
Status:
COMPLETED
Status Verified Date:
2023-04
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 characterize the pharmacokinetics PK of BIVV001 after a single intravenous IV administration as assessed by factor VIII FVIII activity determined by the one-stage activated partial thromboplastin time aPPT clotting assay as well as BIVV001 capture chromogenic Coatest FVIII activity assay
Secondary Objective
-To assess the safety and tolerability of a single IV dose of BIVV001 in adult patients with type 2N and 3 VWD
-To characterize the pharmacokinetics PK of BIVV001 after a single intravenous IV administration as assessed by factor VIII FVIII activity determined by the one-stage activated partial thromboplastin time aPPT clotting assay as well as BIVV001 capture chromogenic Coatest FVIII activity assay
Secondary Objective
-To assess the safety and tolerability of a single IV dose of BIVV001 in adult patients with type 2N and 3 VWD
Detailed Description:
Duration of each part of the study for one participant
Total study duration Up to 57 days
Screening up to 28 days
Up to 29 days of safety observation following the IV BIVV001 dose administration this period includes PK sampling up to the first 10 days following administration
Total study duration Up to 57 days
Screening up to 28 days
Up to 29 days of safety observation following the IV BIVV001 dose administration this period includes PK sampling up to the first 10 days following administration
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 |
|---|---|---|---|
| 2020-004947-10 | EUDRACT_NUMBER | None | None |
| U1111-1255-4463 | OTHER | UTN | None |