Phase 2 Completed N=7 Prevention

IL-11 in Women With Von Willebrand Disease and Refractory Menorrhagia

Von Willebrand Disease

Source: ClinicalTrials.gov NCT00524342 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2014

Primary outcomePrimary: >50% Reduction in PBAC (Pictorial Blood Assessment Chart) at 6 Months — 71 percentage of participants

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.