Ignite Creation Date:
2024-05-06 @ 1:56 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04161495
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2019-11-05
Brief Title:
A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein Efanesoctocog Alfa BIVV001 in Patients With Severe Hemophilia A
Sponsor:
Bioverativ a Sanofi company
Organization:
Sanofi
Study Overview
Official Title:
A Phase 3 Open-Label Multicenter Study of the Safety Efficacy and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein rFVIIIFc-VWF-XTEN BIVV001 in Previously Treated Patients 12 Years of Age With Severe Hemophilia A
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:
XTEND-1
Brief Summary:
Primary Objective
- To evaluate the efficacy of BIVV001 as a prophylaxis treatment in prophylaxis treatment arm
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 the 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 outcomes
To evaluate the efficacy of BIVV001 for perioperative management
To evaluate the safety and tolerability of BIVV001 treatment
To assess the pharmacokinetics PK of BIVV001 based on the 1-stage activated partial thromboplastin time aPTT and 2-stage chromogenic coagulation factor VIII FVIII activity assays
- To evaluate the efficacy of BIVV001 as a prophylaxis treatment in prophylaxis treatment arm
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 the 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 outcomes
To evaluate the efficacy of BIVV001 for perioperative management
To evaluate the safety and tolerability of BIVV001 treatment
To assess the pharmacokinetics PK of BIVV001 based on the 1-stage activated partial thromboplastin time aPTT and 2-stage chromogenic coagulation factor VIII FVIII activity assays
Detailed Description:
Participants in prophylaxis arm received a weekly prophylactic dose of BIVV001 for 52 weeks Participants in on-demand arm received BIVV001 on demand for 26 weeks followed by a switch to weekly prophylaxis for another 26 weeks
The Sponsor planned to perform a long-term safety trial Enrollment in this open-label extension study would be offered to participants completing the treatment period based on eligibility criteria
The Sponsor planned to perform a long-term safety trial Enrollment in this open-label extension study would be offered to participants completing the treatment period based on eligibility criteria
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 |
|---|---|---|---|
| U1111-1223-4867 | REGISTRY | ICTRP | None |
| 2019-002023-15 | EUDRACT_NUMBER | None | None |