Ignite Creation Date:
2024-05-06 @ 12:52 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03879135
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-15
First Post:
2018-12-20
Brief Title:
A Study of Recombinant Von Willebrand Factor rVWF in Pediatric and Adult Participants With Severe Von Willebrand Disease VWD
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
A Phase 3b Prospective Open-Label Uncontrolled Multicenter Study on Long-Term Safety and Efficacy of rVWF in Pediatric and Adult Subjects With Severe Von Willebrand Disease VWD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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 check effectiveness of rVWF vonicog alfa prophylaxis based on the annualized bleeding rate ABR of spontaneous not related to trauma bleeding episodes in pediatric and adult participants during the first 12 months on study treatment
The participants will be treated with rVWF for a maximum of 3 years Their von Willebrand Disease will be treated according to Investigational product IP dosing directions
The participants will be treated with rVWF for a maximum of 3 years Their von Willebrand Disease will be treated according to Investigational product IP dosing directions
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 |
|---|---|---|---|
| 2018-003453-16 | EUDRACT_NUMBER | None | None |