Status:
COMPLETED
Phase II Study of IL-11 (Neumega) in Von Willebrand Disease
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
University of North Carolina
Conditions:
Von Willebrand Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is testing the use of rhIL-11 (recombinant interleukin 11, Neumega) in individuals with Von Willebrand disease. The purpose is to evaluate: 1. if rhIL-11 corrects VWF (Von Willebrand Facto...
Detailed Description
This is a prospective, single center, open-label, escalating dose Phase II comparison study of interleukin-11 (rhIL-11, Neumega) in subjects with type 1 Von Willebrand Disease (VWD). The purpose is t...
Eligibility Criteria
Inclusion
- Males and females 18 years of age or older
- Confirmed VWD by 2 of 4 VWD coagulation tests abnormal
- A past bleeding history
- No hormone, oral contraceptive, estrogen use in past 8 weeks
- Willingness to have blood drawn
- Willingness to sign informed consent
Exclusion
- Presence of other bleeding disorder, e.g. acquired VWD, thrombocytopenia
- Use of estrogens, hormones, oral contraceptives in past 8 weeks
- Use of immunomodulatory or experimental drugs or diuretics
- Pregnant or lactating women
- Past cardiac disease, congestive failure, arrhythmia (e.g. atrial fibrillation, atrial flutter), hypertension, MI, stroke, or thrombosis
- Past allergic reaction to Neumega or DDAVP
- Surgery within the past 8 weeks
- Inability to comply with study protocol requirements
- Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin, or NSAIDs
- Treatment with DDAVP, cryoprecipitate, whole blood, plasma, and plasma derivatives containing FVIII, VWF within 5 days of study
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00151125
Start Date
July 1 2004
End Date
December 1 2007
Last Update
May 17 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hemophilia Center of Western Pennsylvania and General Clinical Research Center
Pittsburgh, Pennsylvania, United States, 15213-4306