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This study is testing the use of rhIL-11 (recombinant interleukin 11, Neumega) in individuals with Von Willebrand disease. The purpose is to evaluate:
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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 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:
age >= 18 years of age 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:
to compare the hemostatic efficacy of three escalating doses of rhIL-11 to determine the biologic effects of rhIL-11 to determine whether DDAVP, when given after the seventh daily dose of rhIL-11, enhances hemostatic efficacy or rhIL-11 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.
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12 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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