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Trial record 1 of 1 for:    NCT00524225
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IL-11 in Adults With Von Willebrand Disease Undergoing Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 : June 11, 2019
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

Tracking Information
First Submitted Date  ICMJE August 31, 2007
First Posted Date  ICMJE September 3, 2007
Results First Submitted Date  ICMJE July 22, 2014
Results First Posted Date  ICMJE November 7, 2014
Last Update Posted Date June 11, 2019
Study Start Date  ICMJE February 2008
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2014)
  • Volume of Surgical Blood Loss [ Time Frame: 4 weeks ]
    Hemostatic efficacy was measured by estimated blood loss (cc) during the surgical procedure.
  • Volume of Blood Transfusion [ Time Frame: 4 weeks ]
    The volume of blood transfusion required (units of blood) after the surgical procedure.
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2007)
  • Efficacy Outcome: Estimated blood loss, frequency and severity of bleeding, and transfusion requirement during and after surgery. [ Time Frame: 4 weeks per subject ]
  • Safety Outcome: number and frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema. [ Time Frame: 4 weeks per subject ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2019)
  • No. of Subjects With Detectable VWFmRNA (Von Willebrand Factor Messenger RNA). [ Time Frame: 4 weeks per subject ]
    The number of subjects with detectable VWFmRNA.
  • Number of Subjects Who Experienced Adverse Events [ Time Frame: The time frame is within 4 weeks of surgery. ]
    mild headache, nausea
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2007)
Mechanism: the number and percent increase in VWD tests (VWF:RCo, VWF:Ag, VIII:C, VIII:Ag, multimers) and VWFmRNA before and after rhIL-11 [ Time Frame: 4 weeks per subject ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IL-11 in Adults With Von Willebrand Disease Undergoing Surgery
Official Title  ICMJE Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease Undergoing Surgery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Von Willebrand Disease
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Drug: Neumega (Oprelvekin, Interleukin 11, IL-11)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 5, 2014)
3
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2007)
10
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00524225
Other Study ID Numbers  ICMJE PRO07030210
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Margaret Ragni, University of Pittsburgh
Study Sponsor  ICMJE Margaret Ragni
Collaborators  ICMJE
  • University of North Carolina
  • Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Margaret V Ragni, MD, MPH University of Pittsburgh Medical Center
PRS Account University of Pittsburgh
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP