Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT00004667
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Study of Human Von Willebrand Factor for Von Willebrand's Disease
Sponsor:
National Center for Research Resources (NCRR)
Organization:
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 Willebrand's 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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UNCCH-826 | None | None | View |