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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
3
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
Hemophilia Center of Western PA
Pittsburgh, Pennsylvania, United States
Volume of Surgical Blood Loss
Hemostatic efficacy was measured by estimated blood loss (cc) during the surgical procedure.
Time frame: 4 weeks
Volume of Blood Transfusion
The volume of blood transfusion required (units of blood) after the surgical procedure.
Time frame: 4 weeks
No. of Subjects With Detectable VWFmRNA (Von Willebrand Factor Messenger RNA).
The number of subjects with detectable VWFmRNA.
Time frame: 4 weeks per subject
Number of Subjects Who Experienced Adverse Events
mild headache, nausea
Time frame: The time frame is within 4 weeks of surgery.
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