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

This study has been completed.
Sponsor:
Collaborators:
University of North Carolina
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00524342
First received: August 31, 2007
Last updated: July 25, 2011
Last verified: July 2011
History of Changes

August 31, 2007
July 25, 2011
January 2008
December 2010   (final data collection date for primary outcome measure)
The primary outcome measure is subjective estimate of blood loss during six menstrual cycles. [ Time Frame: The time frame is up to 7 months per subject ] [ Designated as safety issue: No ]
  • Efficacy Outcome: Subjective estimate of blood loss by subjective bleeding severity scale and by a pictorial bleeding chart during six consecutive cycles [ Time Frame: 6 months per subject ]
  • Safety Outcome: number and frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema. [ Time Frame: 6 months per subject ]
Complete list of historical versions of study NCT00524342 on ClinicalTrials.gov Archive Site
  • A secondary outcome measure is the mechanism of IL-11 effect by VWF mRNA. [ Time Frame: The time frame is up to 7 months per subject. ] [ Designated as safety issue: No ]
  • A secondary outcome measure is the frequency of IL-11 associated adverse events. [ Time Frame: The time frame is up to 7 months per subject. ] [ Designated as safety issue: Yes ]
Mechanism: the number and percent increase in VWD tests (VWF:RCo, VWF:Ag, VIII:C, VIII:Ag, multimers) and VWFmRNA before and after rhIL-11 [ Time Frame: 6 months per subject ]
Not Provided
Not Provided
 
IL-11 in Women With Von Willebrand Disease and Refractory Menorrhagia
Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Women With Type 1 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.

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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Von Willebrand Disease
Drug: Neumega (Oprelvekin, Interleukin 11, IL-11)
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 Name: Neumega (Oprelvekin, Interleukin 11, IL-11)
Experimental: A
Intervention: Drug: Neumega (Oprelvekin, Interleukin 11, IL-11)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00524342
PRO07040157, Wyeth 102344
Yes
Margaret V. Ragni, MD, MPH, Principal Investigator, Professor of Medicine, University of Pittsburgh
University of Pittsburgh
  • University of North Carolina
  • Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Margaret V. Ragni, MD, MPH University of Pittsburgh
University of Pittsburgh
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP