Ignite Creation Date:
2024-05-06 @ 6:13 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05582993
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-02
First Post:
2022-10-14
Brief Title:
A Study of Recombinant Von Willebrand Factor rVWF TAK-577 in Children With Severe Von Willebrand Disease vWD
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 3 Prospective Open-label Uncontrolled Multicenter Study on Efficacy and Safety of Prophylaxis With rVWF in Children Diagnosed With Severe Von Willebrand Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
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:
None
Brief Summary:
The main aim of the study is to evaluate the effectiveness of prophylaxis with recombinant von Willebrand factor rVWF in children This study will enroll those participants who have been previously treated with VWF product or with a plasma-derived VWF pdVWF product In this study participants will be treated with rVWF for 12 months
During the study participants will visit the study clinic 6 times after treatment initiation
During the study participants will visit the study clinic 6 times after treatment initiation
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 |
|---|---|---|---|
| 2020-003304-13 | EUDRACT_NUMBER | None | None |