Phase II Study of IL-11 (Neumega) in Von Willebrand Disease
NCT ID: NCT00151125
Last Updated: 2016-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2004-07-31
2007-12-31
Brief Summary
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1. if rhIL-11 corrects VWF (Von Willebrand Factor) levels to normal
2. if rhIL-11 and DDAVP together will boost VWF levels even higher
3. the onset, peak, and duration of rhIL-11 effect
4. if rhIL-11 is safe in individuals with Von Willebrand Disease
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Detailed Description
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The purpose is to establish the clinical safety and hemostatic efficacy of rhIL-11 in individuals with type 1 Von Willebrand disease.
Study subjects will include the following subjects:
1. age \>= 18 years of age
2. diagnosis of VWD confirmed by: 2a) at least 2 of 4 abnormal vWD-related coagulation tests; 2b) a past bleeding history
A total of 10-16 subjects are anticipated to be enrolled and complete the study. The specific aims of the study are:
1. to compare the hemostatic efficacy of three escalating doses of rhIL-11
2. to determine the biologic effects of rhIL-11
3. to determine whether DDAVP, when given after the seventh daily dose of rhIL-11, enhances hemostatic efficacy or rhIL-11
4. to compare the safety of three escalating doses of rhIL-11
Efficacy will be based on the number and percent increase of VWD-related coagulation tests into the normal range, or at least to 2-3 times baseline.
Safety will be based on the number and frequency of adverse reactions, including fever, headache, fatigue, arthralgias, myalgias, fluid retention, and edema.
The study will last up to 4 weeks per subject, and for 24 months for the entire study.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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C
rhIL-11 (Interleukin-11, Neumega) 10 mg/kg subcutaneously daily for 7 days
recombinant interleukin-11
10 mcg/kg subcutaneously daily for 7 days
A
rhIL-11 (Interleukin-11, Neumega) 25 mcg/kg subcutaneously daily for 7 days
recombinant interleukin-11
25 mcg/kg subcutaneously daily for seven days
B
rhIL-11 (interleukin-11, Neumega) 50 mcg/kg subcutaneously daily for 7 days
recombinant interleukin-11
50 mcg/kg subcutaneously daily for 7 days
Interventions
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recombinant interleukin-11
25 mcg/kg subcutaneously daily for seven days
recombinant interleukin-11
50 mcg/kg subcutaneously daily for 7 days
recombinant interleukin-11
10 mcg/kg subcutaneously daily for 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
University of North Carolina
OTHER
University of Pittsburgh
OTHER
Responsible Party
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Margaret Ragni
Professor of Medicine
Principal Investigators
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Margaret V. Ragni, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Hemophilia Center of Western Pennsylvania and General Clinical Research Center
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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0403006
Identifier Type: OTHER
Identifier Source: secondary_id
0403006
Identifier Type: -
Identifier Source: org_study_id
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