IL-11 in Women With Von Willebrand Disease and Refractory Menorrhagia
Keywords
Abstract
Description
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.
Dates
| Last Verified: | 12/31/2017 |
| First Submitted: | 08/30/2007 |
| Estimated Enrollment Submitted: | 08/30/2007 |
| First Posted: | 09/02/2007 |
| Last Update Submitted: | 01/04/2018 |
| Last Update Posted: | 01/30/2018 |
| Date of first submitted results: | 06/03/2014 |
| Date of first submitted QC results: | 11/04/2014 |
| Date of first posted results: | 11/06/2014 |
| Actual Study Start Date: | 12/31/2007 |
| Estimated Primary Completion Date: | 11/30/2010 |
| Estimated Study Completion Date: | 11/30/2010 |
Condition or disease
Intervention/treatment
Drug: Oprelvekin, Interleukin 11, IL-11
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Oprelvekin, Interleukin 11, IL-11 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles | Drug: Oprelvekin, Interleukin 11, IL-11 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. >50% Reduction in PBAC (Pictorial Blood Assessment Chart) at 6 Months [6 months]
Secondary Outcome Measures
1. No. of Subjects With Detectable VWF mRNA (Von Willebrand Factor Messenger RNA). [The time frame is up to 7 months per subject.]
2. No. of Subjects With IL-11 Associated Adverse Events. [The time frame is up to 7 months per subject.]
