Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759131
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2021-02-13
Brief Title:
Safety Efficacy and PK of BIVV001 in Pediatric Patients With 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 Pediatric Patients 12 Years of Age With Severe Hemophilia A
Status:
COMPLETED
Status Verified Date:
2024-01
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-Kids
Brief Summary:
Primary Objective
- To evaluate the safety of BIVV001 in previously treated pediatric participants 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 efficacy of BIVV001 for perioperative management
To evaluate the safety and tolerability of BIVV001 treatment
To assess the pharmacokinetics PK of BIVV001
- To evaluate the safety of BIVV001 in previously treated pediatric participants 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 efficacy of BIVV001 for perioperative management
To evaluate the safety and tolerability of BIVV001 treatment
To assess the pharmacokinetics PK of BIVV001
Detailed Description:
Study duration per participants was approximately 60 weeks maximum 8 weeks for screening and 52 weeks of treatment
All participants completing or remaining at the end of study were offered participation in the planned extension trial
All participants completing or remaining at the end of study were offered participation in the planned extension trial
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 |
|---|---|---|---|
| 017464 | OTHER | IND | None |
| 2020-000769-18 | EUDRACT_NUMBER | None | None |
| U1111-1244-0558 | OTHER | None | None |