Ignite Creation Date:
2024-05-06 @ 2:48 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04431726
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2020-06-11
Brief Title:
A Study to Evaluate the Efficacy Safety Pharmacokinetics and Pharmacodynamics of Subcutaneous Emicizumab in Participants From Birth to 12 Months of Age With Hemophilia A Without Inhibitors
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase IIIb Multicenter Open-Label Single-Arm Study to Evaluate the Efficacy Safety Pharmacokinetics and Pharmacodynamics of Subcutaneous Emicizumab in Patients From Birth to 12 Months of Age With Hemophilia A Without Inhibitors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
HAVEN 7
Brief Summary:
This is a Phase IIIb multicenter open-label single-arm study of prophylactic emicizumab in previously untreated and minimally treated patients at study enrollment from birth to 12 months of age with severe hemophilia A intrinsic factor VIII FVIII level 1 without FVIII inhibitors The study is designed to evaluate the efficacy safety pharmacokinetics and pharmacodynamics of emicizumab administered at 3 milligrams per kilogram of body weight mgkg once every 2 weeks Q2W for 52 weeks After 1 year of treatment participants will continue to receive emicizumab 15 mgkg once every week QW 3 mgkg Q2W or 6 mgkg once every 4 weeks Q4W over a 7-year long-term follow-up period under this study frame
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 |
|---|---|---|---|
| 2023-505964-13-00 | REGISTRY | EU CT Number | None |
| 2020-001733-12 | EUDRACT_NUMBER | None | None |