Ignite Creation Date:
2024-05-06 @ 7:51 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02615691
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-11
First Post:
2015-11-24
Brief Title:
A Study of PEGylated Recombinant Factor VIII BAX855 in Previously Untreated Young Children With Severe Hemophilia A
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
Phase 3 Prospective Multi-center Open Label Study to Investigate Safety Immunogenicity and Hemostatic Efficacy of PEGylated Factor VIII BAX 855 in Previously Untreated Patients PUPs 6 Years With Severe Hemophilia A FVIII 1
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
This study is for young children with severe hemophilia A who have previously not been treated with BAX855 or other FVIII concentrates
The main aim of the study is to check for side effects from treatment with BAX855 This includes the buildup of antibodies against FVIII which may stop BAX855 from working properly Another aim is to learn how well BAX855 controls bleeding
In this study the children can receive BAX855 either as preventative treatment prophylaxis or as needed to treat bleeding on-demand
In case a participant develops antibodies treatment will be provided as part of the study
The main aim of the study is to check for side effects from treatment with BAX855 This includes the buildup of antibodies against FVIII which may stop BAX855 from working properly Another aim is to learn how well BAX855 controls bleeding
In this study the children can receive BAX855 either as preventative treatment prophylaxis or as needed to treat bleeding on-demand
In case a participant develops antibodies treatment will be provided as part of the study
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-002136-40 | EUDRACT_NUMBER | None | None |