Ignite Creation Date:
2024-05-06 @ 10:16 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03205163
Status:
COMPLETED
Last Update Posted:
2022-04-19
First Post:
2017-06-29
Brief Title:
A Safety Tolerability and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein rFVIIIFc-VWF-XTEN BIVV001 in Previously Treated Adults With Severe Hemophilia A EXTEN-A
Sponsor:
Bioverativ a Sanofi company
Organization:
Sanofi
Study Overview
Official Title:
A Phase 12a Open-Label Dose-Escalation Study to Determine the Safety Tolerability and Pharmacokinetics of a Single Intravenous Injection of rFVIIIFc-VWF-XTEN BIVV001 in Previously Treated Adults With Severe Hemophilia A
Status:
COMPLETED
Status Verified Date:
2022-03
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 primary purpose was to assess the safety and tolerability of a single intravenous IV administration of BIVV001 in adult previously treated patients PTPs with severe hemophilia A
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 242HA101 | OTHER | Bioverativ a Sanofi company | None |