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Completed

NCT Number: NCT00524342

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

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.

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Key information

Conditions

Von Willebrand Disease Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Menorrhagia Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage von Willebrand Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hemophilia Center of Western PA

Pittsburgh, Pennsylvania, 15213-4306, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oprelvekin, Interleukin 11, IL-11

Drug

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

Other names: Neumega (Oprelvekin, Interleukin 11, IL-11)

Primary outcomes

  1. >50% Reduction in PBAC (Pictorial Blood Assessment Chart) at 6 Months

    Time frame: 6 months

    Subjective estimate of blood loss was measured by using a Pictorial blood assessment chart (PBAC) . The PBAC measures scores on a scale where 0 to 100 is normal and greater than 100-200 are abnormal.

Secondary outcomes

  1. No. of Subjects With Detectable VWF mRNA (Von Willebrand Factor Messenger RNA).

    Time frame: The time frame is up to 7 months per subject.

    No. of subjects with detectable VWFmRNA, a measure of IL-11 (interleukin-11) function, specifically increasing VWF synthesis.

  2. No. of Subjects With IL-11 Associated Adverse Events.

    Time frame: The time frame is up to 7 months per subject.

    The number of subjects with IL-11 associated adverse events.

Sponsors and collaborators

Lead sponsor

Margaret Ragni

Other

Collaborators

  • University of North Carolina
  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 3, 2007
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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