Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04644575
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2020-11-23
Brief Title:
Long-term Safety and Efficacy of Efanesoctocog Alfa BIVV001 in Previously Treated Patients With Hemophilia A
Sponsor:
Bioverativ a Sanofi company
Organization:
Sanofi
Study Overview
Official Title:
A Phase 3 Open-label Multicenter Study of the Long-term Safety and Efficacy of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein rFVIIIFc-VWF-XTEN BIVV001 in Previously Treated Patients With Severe Hemophilia A
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
XTEND-ed
Brief Summary:
Primary Objective
- To evaluate the long-term safety of BIVV001 in previously treated subjects with hemophilia A
Secondary Objectives
To evaluate the efficacy of BIVV001 as a prophylaxis treatment
To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes
To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes
To evaluate the effect of BIVV001 prophylaxis on joint health outcomes
To evaluate the effect of BIVV001 prophylaxis on Quality of Life QoL outcomes
To evaluate the safety and tolerability of BIVV001 treatment
To assess the PK of BIVV001 based on the one stage activated partial thromboplastin time aPTT and two-stage chromogenic FVIII activity assays only applicable to Arm B
To evaluate the efficacy of BIVV001 for perioperative management
- To evaluate the long-term safety of BIVV001 in previously treated subjects with hemophilia A
Secondary Objectives
To evaluate the efficacy of BIVV001 as a prophylaxis treatment
To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes
To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes
To evaluate the effect of BIVV001 prophylaxis on joint health outcomes
To evaluate the effect of BIVV001 prophylaxis on Quality of Life QoL outcomes
To evaluate the safety and tolerability of BIVV001 treatment
To assess the PK of BIVV001 based on the one stage activated partial thromboplastin time aPTT and two-stage chromogenic FVIII activity assays only applicable to Arm B
To evaluate the efficacy of BIVV001 for perioperative management
Detailed Description:
Participants will receive BIVV001 once weekly for a total of at least 100 exposure days to BIVV001 including exposure during a BIVV001 parent study if applicable Participants will have the opportunity to continue in this study for up to 4 years unless BIVV001 is commercially available in their applicable participating country
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 |
|---|---|---|---|
| 2020-002215-22 | EUDRACT_NUMBER | CTIS | None |
| U1111-1244-0517 | REGISTRY | None | None |
| 2023-508929-27-00 | REGISTRY | None | None |