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IL-11 in Adults With Von Willebrand Disease Undergoing Surgery

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ClinicalTrials.gov Identifier: NCT00524225
Recruitment Status : Terminated (Recruitment slow as single center conducting in rare disease)
First Posted : September 3, 2007
Results First Posted : November 7, 2014
Last Update Posted : March 13, 2018
Sponsor:
Collaborators:
University of North Carolina
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Margaret Ragni, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Von Willebrand Disease Drug: Neumega (Oprelvekin, Interleukin 11, IL-11) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : February 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Oprelvekin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Neumega (Interleukin 11, IL-11)
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
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



Primary Outcome Measures :
  1. Volume of Surgical Blood Loss [ Time Frame: 4 weeks ]
    Hemostatic efficacy was measured by estimated blood loss (cc) during the surgical procedure.

  2. Volume of Blood Transfusion [ Time Frame: 4 weeks ]
    The volume of blood transfusion required (units of blood) after the surgical procedure.


Secondary Outcome Measures :
  1. No. of Subjects With Detectable VWFmRNA (Von Willebrand Factor Messenger RNA). [ Time Frame: 4 weeks per subject ]
    The number of subjects with detectable VWFmRNA.

  2. Number of Participants [ Time Frame: The time frame is within 4 weeks of surgery. ]
    mild headache, nausea



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00524225


Locations
United States, Pennsylvania
Hemophilia Center of Western PA
Pittsburgh, Pennsylvania, United States, 15213-4306
Sponsors and Collaborators
Margaret Ragni
University of North Carolina
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Margaret V Ragni, MD, MPH University of Pittsburgh

Publications:
Responsible Party: Margaret Ragni, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00524225     History of Changes
Other Study ID Numbers: PRO07030210
First Posted: September 3, 2007    Key Record Dates
Results First Posted: November 7, 2014
Last Update Posted: March 13, 2018
Last Verified: February 2018

Keywords provided by Margaret Ragni, University of Pittsburgh:
IL-11
von Willebrand disease
von Willebrand factor
VWFmRNA
surgery

Additional relevant MeSH terms:
Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Oprelvekin
Antineoplastic Agents