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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00524342
First Posted: September 3, 2007
Last Update Posted: September 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of North Carolina
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Margaret Ragni, University of Pittsburgh
August 31, 2007
September 3, 2007
June 4, 2014
November 7, 2014
September 18, 2017
January 2008
December 2010   (Final data collection date for primary outcome measure)
>50% Reduction in PBAC 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.
  • 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. ]
  • 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. ]
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Von Willebrand Disease
Drug: 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: 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
Intervention: Drug: 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
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00524342
PRO07040157
Wyeth 102344 ( Other Identifier: Wyeth )
Yes
Not Provided
Not Provided
Margaret Ragni, University of Pittsburgh
Margaret Ragni
  • 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
September 2017

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