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

This study is currenly Recruiting patients.

Sponsored by: University of Pittsburgh

Purpose

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.

Study Type: Intervention

Condition	Intervention	Phase
Von Willebrand Disease	Drug: Neumega (Oprelvekin, Interleukin 11, IL-11)	Phase 2

Study Design:Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Official Title: Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Women With Type 1 Von Willebrand Disease and Refractory Menorrhagia

Further Study Details:

Expected Total Enrollment:

Study Dates:January 2008 -

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.

Eligibility

Ages Eligible for Study- Min: 18 Years Max: 45 Years

Gender: Female

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier: NCT00524342

Pennsylvania

Hemophilia Center of Western PA - Pittsburgh, Pennsylvania 15213-4306

Margaret V. Ragni, MD, MPH 412-209-7288 ragni@dom.pitt.edu

More Information

Record Last Reviewed:January 2010

Last Updated:January 12, 2010

Record First Recieved:August 31, 2007

ClinicalTrials.gov Identifier:NCT00524342

Health Authority: United States Food and Drug Administration

Information obtained from ClinicalTrials.gov on September 02, 2010