Phase 2
N=7
IL-11 in Women With Von Willebrand Disease and Refractory Menorrhagia
Von Willebrand Disease
Bottom Line
View on ClinicalTrials.gov: NCT00524342 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: >50% Reduction in PBAC (Pictorial Blood Assessment Chart) at 6 Months — 71 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oprelvekin, Interleukin 11, IL-11 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Margaret Ragni
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY >50% Reduction in PBAC (Pictorial Blood Assessment Chart) at 6 Months |
71 | — |
| SECONDARY No. of Subjects With Detectable VWF mRNA (Von Willebrand Factor Messenger RNA). |
7 | — |
| SECONDARY No. of Subjects With IL-11 Associated Adverse Events. |
6; 6; 3 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00524342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.