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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
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

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

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: von Willebrand's disease

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    University of North Carolina
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    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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    Learn more about this trial

    Phase I Study of Human Von Willebrand Factor for Von Willebrand's Disease

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