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IL-11 in Adults With Von Willebrand Disease Undergoing Surgery

Primary Purpose

Von Willebrand Disease

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Neumega (Oprelvekin, Interleukin 11, IL-11)

About this trial

This is an interventional prevention trial for Von Willebrand Disease focused on measuring IL-11, von Willebrand disease, von Willebrand factor, VWFmRNA, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hemophilia Center of Western PA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neumega (Interleukin 11, IL-11)

Arm Description

Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively

Outcomes

Primary Outcome Measures

Volume of Surgical Blood Loss

Hemostatic efficacy was measured by estimated blood loss (cc) during the surgical procedure.

Volume of Blood Transfusion

The volume of blood transfusion required (units of blood) after the surgical procedure.

Secondary Outcome Measures

No. of Subjects With Detectable VWFmRNA (Von Willebrand Factor Messenger RNA).

The number of subjects with detectable VWFmRNA.

Number of Subjects Who Experienced Adverse Events

mild headache, nausea

Full Information

NCT ID

NCT00524225

First Posted

August 31, 2007

Last Updated

June 2, 2019

Sponsor

Margaret Ragni

Collaborators

University of North Carolina, Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00524225

Brief Title

IL-11 in Adults With Von Willebrand Disease Undergoing Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Terminated

Why Stopped

Recruitment slow as single center conducting in rare disease

Study Start Date

February 2008 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Margaret Ragni

Collaborators

University of North Carolina, Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Von Willebrand Disease

Keywords

IL-11, von Willebrand disease, von Willebrand factor, VWFmRNA, surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Neumega (Interleukin 11, IL-11)

Arm Type

Experimental

Arm Description

Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively

Intervention Type

Drug

Intervention Name(s)

Neumega (Oprelvekin, Interleukin 11, IL-11)

Intervention Description

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

Primary Outcome Measure Information:

Title

Volume of Surgical Blood Loss

Description

Hemostatic efficacy was measured by estimated blood loss (cc) during the surgical procedure.

Time Frame

4 weeks

Title

Volume of Blood Transfusion

Description

The volume of blood transfusion required (units of blood) after the surgical procedure.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

No. of Subjects With Detectable VWFmRNA (Von Willebrand Factor Messenger RNA).

Description

The number of subjects with detectable VWFmRNA.

Time Frame

4 weeks per subject

Title

Number of Subjects Who Experienced Adverse Events

Description

mild headache, nausea

Time Frame

The time frame is within 4 weeks of surgery.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Margaret V Ragni, MD, MPH

Organizational Affiliation

University of Pittsburgh Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hemophilia Center of Western PA

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213-4306

Country

United States

12. IPD Sharing Statement

Citations:

Citation

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).

Results Reference

background

PubMed Identifier

18680527

Citation

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.

Results Reference

background

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IL-11 in Adults With Von Willebrand Disease Undergoing Surgery

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