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

Margaret Ragni

Status and phase: Completed; Phase 2

Conditions: Von Willebrand Disease

Treatments: Drug: Oprelvekin, Interleukin 11, IL-11

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00524342

PRO07040157

Wyeth 102344 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Oprelvekin, Interleukin 11, IL-11

Experimental group

Description:

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

Treatment:

Drug: Oprelvekin, Interleukin 11, IL-11