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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 (Responsible Party):
Margaret Ragni, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00524342
First received: August 31, 2007
Last updated: November 5, 2014
Last verified: November 2014
  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.


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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • >50% Reduction in PBAC at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ]

Enrollment: 7
Study Start Date: January 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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)

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
Hemophilia Center of Western PA
Pittsburgh, Pennsylvania, United States, 15213-4306
Sponsors and Collaborators
University of Pittsburgh
University of North Carolina
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Margaret V. Ragni, MD, MPH University of Pittsburgh
  More Information

Publications:
Responsible Party: Margaret Ragni, Laurel Yasko, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00524342     History of Changes
Other Study ID Numbers: PRO07040157, Wyeth 102344
Study First Received: August 31, 2007
Results First Received: June 4, 2014
Last Updated: November 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
IL-11
von Willebrand disease
von Willebrand factor
VWFmRNA
menorrhagia

Additional relevant MeSH terms:
Menorrhagia
Von Willebrand Disease, Type 1
Von Willebrand Diseases
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Blood Platelet Disorders
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genital Diseases, Female
Hematologic Diseases
Hemorrhagic Disorders
Menstruation Disturbances
Pathologic Processes
Uterine Diseases
Uterine Hemorrhage
Oprelvekin
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014