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IL-11 in Adults With Von Willebrand Disease Undergoing Surgery

NCT00524225 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-06-11

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 in adults with type 1 von Willebrand disease undergoing elective surgery or major dental procedure. Efficacy will be measured by estimated blood loss, and frequency and severity of bleeding and transfusion requirement during and after surgery. 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

Neumega (Oprelvekin, Interleukin 11, IL-11)

25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2012-06-30
Completion
2012-06-30

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 NCT00524225 on ClinicalTrials.gov