IL-11 in Adults With Von Willebrand Disease Undergoing Surgery

Von Willebrand Disease Clinical Trial

Official title:

Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease Undergoing Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00524225
• Other study ID #: PRO07030210
• Status: Terminated
• Phase: Phase 2
• Start date: February 2008
• Est. completion date: June 2012

Study information

• Verified date: June 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and females 18 years of age and older

• Confirmed type 1 VWD, as defined by low VWF:RCoF or low VWF:Ag and qualitatively normal VWF multimers

• A past bleeding history

• Responsive to DDAVP

• Scheduled elective major surgery or major dental surgery at MUH or PUH

• Willingness to have blood drawn

Exclusion Criteria:

• Presence of other bleeding disorders, acquired Von Willebrand disease, primary thrombocytopenia

• 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

• 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

Related Conditions & MeSH terms

• Von Willebrand Disease
• Von Willebrand Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Hemophilia Center of Western PA	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Margaret Ragni	University of North Carolina, Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (2)

Jankowitz RC, Nichols TC, Ragni MV. Recombinant IL-11 (Neumega, rhIL-11) increases plasma Von Willebrand Factor in Type 1 Von Willebrand Disease. Blood 108: 1003, 2006 (abstract).

Ragni MV, Jankowitz RC, Chapman HL, Merricks EP, Kloos MT, Dillow AM, Nichols TC. A phase II prospective open-label escalating dose trial of recombinant interleukin-11 in mild von Willebrand disease. Haemophilia. 2008 Sep;14(5):968-77. doi: 10.1111/j.1365-2516.2008.01827.x. Epub 2008 Aug 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of Surgical Blood Loss	Hemostatic efficacy was measured by estimated blood loss (cc) during the surgical procedure.	4 weeks
Primary	Volume of Blood Transfusion	The volume of blood transfusion required (units of blood) after the surgical procedure.	4 weeks
Secondary	No. of Subjects With Detectable VWFmRNA (Von Willebrand Factor Messenger RNA).	The number of subjects with detectable VWFmRNA.	4 weeks per subject
Secondary	Number of Subjects Who Experienced Adverse Events	mild headache, nausea	The time frame is within 4 weeks of surgery.