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

NCT00524342 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2018-01-31

Study results available
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Summary

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.

Conditions

  • Von Willebrand Disease

Interventions

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

Sponsors & Collaborators

  • University of North Carolina

    collaborator OTHER

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Margaret Ragni

    lead OTHER

Principal Investigators

  • Margaret V. Ragni, MD, MPH · University of Pittsburgh Medical Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00524342 on ClinicalTrials.gov