IL-11 in Women With Von Willebrand Disease and Refractory Menorrhagia
Status: | Completed |
---|---|
Conditions: | Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 2/2/2018 |
Start Date: | January 2008 |
End Date: | December 2010 |
Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Women With Type 1 Von Willebrand Disease and Refractory Menorrhagia
The purpose of this study is to determine the efficacy and safety of rhIL-11, when given
subcutaneously for six consecutive months, in reducing menstrual blood loss in women with
type 1 von Willebrand disease and refractory menorrhagia. Efficacy will be measured by
subjective bleeding severity scale and pictorial bleeding chart. Safety will be measured by
the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias,
fluid retention, or edema.
subcutaneously for six consecutive months, in reducing menstrual blood loss in women with
type 1 von Willebrand disease and refractory menorrhagia. Efficacy will be measured by
subjective bleeding severity scale and pictorial bleeding chart. Safety will be measured by
the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias,
fluid retention, or edema.
This study is a prospective, single-center Phase II trial of Neumega (rhIL-11) in women with
type 1 VWD and menorrhagia refractory to estrogen, hormones, or hemostatic agents. It is
anticipated that 10 subjects who meet eligibility criteria will enroll and complete this
study. All aspects of this study, including the rhIL-11 injections and the screening,
hemostatic and safety monitoring, and coagulation testing, are considered experimental. The
specific objectives are to determine the efficacy and safety of rhIL-11 in reducing menstrual
blood loss in adult women with type 1 VWD during six consecutive menstrual cycles, and to
determine the mechanism of the hemostatic response of rhIL-11.
type 1 VWD and menorrhagia refractory to estrogen, hormones, or hemostatic agents. It is
anticipated that 10 subjects who meet eligibility criteria will enroll and complete this
study. All aspects of this study, including the rhIL-11 injections and the screening,
hemostatic and safety monitoring, and coagulation testing, are considered experimental. The
specific objectives are to determine the efficacy and safety of rhIL-11 in reducing menstrual
blood loss in adult women with type 1 VWD during six consecutive menstrual cycles, and to
determine the mechanism of the hemostatic response of rhIL-11.
Inclusion Criteria:
- Females 18-45 years of age
- Confirmed type 1 VWD, as defined by low VWF:RCoF or low VWF:Ag and qualitatively
normal VWF multimers
- Menorrhagia refractory to estrogens, hormones, hemostatic agents
- Willingness to have blood drawn
Exclusion Criteria:
- Use of immunomodulatory or experimental drugs, or diuretics
- Pregnant or lactating women or those unwilling to use contraception during study
- Previous 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 substantial quantities of FVIII and/or VWF within five days of study
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