Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004667
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase I Study of Human Von Willebrand Factor for Von Willebrands Disease
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
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:
OBJECTIVES I Evaluate the effect of a new von Willebrand factor concentrate on bleeding time in vivo recovery and circulating half-life of the infused factor in patients with von Willebrands disease
II Assess the safety of von Willebrand factor in these patients
II Assess the safety of von Willebrand factor in these patients
Detailed Description:
PROTOCOL OUTLINE Patients receive 1 dose of von Willebrand factor concentrate Timed blood studies are performed for the next 96 hours
Patients are followed every 2 weeks for 16 weeks and at 24 36 and 52 weeks
Patients are followed every 2 weeks for 16 weeks and at 24 36 and 52 weeks
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UNCCH-826 | None | None | None |