IL-11 in Adults With Von Willebrand Disease Undergoing Surgery

Status Terminated

Clinical Trial 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.

Clinical Trial Description

This study is a prospective, single-center Phase II trial of Neumega (rhIL-11) in adults with type 1 VWD undergoing elective surgery or major dental procedure. It is anticipated that 10 subjects who meet eligibility criteria will enroll and complete the study. The specific objectives are to determine the efficacy and safety or rhIL-11 during and after elective surgery, and to determine the mechanism of the hemostatic response of rhIL-11. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00524225
Study type	Interventional
Source	University of Pittsburgh
Contact
Status	Terminated
Phase	Phase 2
Start date	February 2008
Completion date	June 2012

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