Phase I Study of Human Von Willebrand Factor for Von Willebrand's Disease
Primary Purpose
Von Willebrand's Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
von Willebrand factor
Sponsored by
About this trial
This is an interventional treatment trial for Von Willebrand's Disease focused on measuring hematologic disorders, rare disease, von Willebrand's disease
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: von Willebrand's disease
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004667
First Posted
February 24, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of North Carolina
1. Study Identification
Unique Protocol Identification Number
NCT00004667
Brief Title
Phase I Study of Human Von Willebrand Factor for Von Willebrand's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2001
Overall Recruitment Status
Completed
Study Start Date
October 1993 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of North Carolina
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Von Willebrand's Disease
Keywords
hematologic disorders, rare disease, von Willebrand's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
von Willebrand factor
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
PROTOCOL ENTRY CRITERIA:
von Willebrand's disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilbert C. White
Organizational Affiliation
University of North Carolina
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
8826903
Citation
Menache D, Aronson DL, Darr F, Montgomery RR, Gill JC, Kessler CM, Lusher JM, Phatak PD, Shapiro AD, Thompson AR, White GC 2nd. Pharmacokinetics of von Willebrand factor and factor VIIIC in patients with severe von Willebrand disease (type 3 VWD): estimation of the rate of factor VIIIC synthesis. Cooperative Study Groups. Br J Haematol. 1996 Sep;94(4):740-5. doi: 10.1046/j.1365-2141.1996.d01-1860.x.
Results Reference
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Phase I Study of Human Von Willebrand Factor for Von Willebrand's Disease
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