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Trial record 1 of 1 for:    NCT00151125
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Phase II Study of IL-11 (Neumega) in Von Willebrand Disease

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: NCT00151125
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : May 17, 2016
Sponsor:
Collaborators:
Wyeth is now a wholly owned subsidiary of Pfizer
University of North Carolina
Information provided by (Responsible Party):
Margaret Ragni, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE September 6, 2005
First Posted Date  ICMJE September 8, 2005
Last Update Posted Date May 17, 2016
Study Start Date  ICMJE July 2004
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2008)
The number and percent increase of VWD coagulation tests after seven daily doses of rhIL-11, boosted by DDAVP day 7. [ Time Frame: The time frame is up to 14 days per subject. ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2005)
  • 1) the number and percent increase of VWD coagulation tests after seven daily doses of rhIL-11, boosted by DDAVP day 7.
  • 2) the biologic effects of rhIL-11 for up to 4 hours after IL-11 on days 1, 4, and 7, measured by VWD coagulation tests
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2008)
  • The number and frequency of IL-11 associated adverse events. [ Time Frame: The time frame is up to 14 days per subject. ]
  • The mechanism of IL-11 biologic effect by VWFmRNA. [ Time Frame: The time frame is within 14 days per subject. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2005)
  • 1) the number and frequency of adverse events, including fever, chills, headache, fatigue, edema, myalgia, arthralgia
  • 2) the frequency of fluid retention, peripheral edema, and dyspnea on exertion
  • 3) the frequency and degree of a 10-15% fall in hematocrit from baseline
  • 4) the increase in VWF:mRNA in platelet-rich plasma on days 7 and 14 following rhIL-11 infusion
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study of IL-11 (Neumega) in Von Willebrand Disease
Official Title  ICMJE Phase II Comparison Study of Hemostatic Efficacy of Escalating Doses of Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease
Brief Summary

This study is testing the use of rhIL-11 (recombinant interleukin 11, Neumega) in individuals with Von Willebrand disease. The purpose is to evaluate:

  1. if rhIL-11 corrects VWF (Von Willebrand Factor) levels to normal
  2. if rhIL-11 and DDAVP together will boost VWF levels even higher
  3. the onset, peak, and duration of rhIL-11 effect
  4. if rhIL-11 is safe in individuals with Von Willebrand Disease
Detailed Description

This is a prospective, single center, open-label, escalating dose Phase II comparison study of interleukin-11 (rhIL-11, Neumega) in subjects with type 1 Von Willebrand Disease (VWD).

The purpose is to establish the clinical safety and hemostatic efficacy of rhIL-11 in individuals with type 1 Von Willebrand disease.

Study subjects will include the following subjects:

  1. age >= 18 years of age
  2. diagnosis of VWD confirmed by: 2a) at least 2 of 4 abnormal vWD-related coagulation tests; 2b) a past bleeding history

A total of 10-16 subjects are anticipated to be enrolled and complete the study. The specific aims of the study are:

  1. to compare the hemostatic efficacy of three escalating doses of rhIL-11
  2. to determine the biologic effects of rhIL-11
  3. to determine whether DDAVP, when given after the seventh daily dose of rhIL-11, enhances hemostatic efficacy or rhIL-11
  4. to compare the safety of three escalating doses of rhIL-11

Efficacy will be based on the number and percent increase of VWD-related coagulation tests into the normal range, or at least to 2-3 times baseline.

Safety will be based on the number and frequency of adverse reactions, including fever, headache, fatigue, arthralgias, myalgias, fluid retention, and edema.

The study will last up to 4 weeks per subject, and for 24 months for the entire study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Von Willebrand Disease
Intervention  ICMJE
  • Drug: recombinant interleukin-11
    25 mcg/kg subcutaneously daily for seven days
    Other Name: rhIL-11, Neumega
  • Drug: recombinant interleukin-11
    50 mcg/kg subcutaneously daily for 7 days
    Other Name: rhIL-11, Neumega
  • Drug: recombinant interleukin-11
    10 mcg/kg subcutaneously daily for 7 days
    Other Name: rhIL-11, Neumega
Study Arms  ICMJE
  • Experimental: A
    rhIL-11 (Interleukin-11, Neumega) 25 mcg/kg subcutaneously daily for 7 days
    Intervention: Drug: recombinant interleukin-11
  • Experimental: B
    rhIL-11 (interleukin-11, Neumega) 50 mcg/kg subcutaneously daily for 7 days
    Intervention: Drug: recombinant interleukin-11
  • Experimental: C
    rhIL-11 (Interleukin-11, Neumega) 10 mg/kg subcutaneously daily for 7 days
    Intervention: Drug: recombinant interleukin-11
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2008)
12
Original Enrollment  ICMJE
 (submitted: September 6, 2005)
9
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females 18 years of age or older
  • Confirmed VWD by 2 of 4 VWD coagulation tests abnormal
  • A past bleeding history
  • No hormone, oral contraceptive, estrogen use in past 8 weeks
  • Willingness to have blood drawn
  • Willingness to sign informed consent

Exclusion Criteria:

  • Presence of other bleeding disorder, e.g. acquired VWD, thrombocytopenia
  • Use of estrogens, hormones, oral contraceptives in past 8 weeks
  • Use of immunomodulatory or experimental drugs or diuretics
  • Pregnant or lactating women
  • Past 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 FVIII, VWF within 5 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 NCT00151125
Other Study ID Numbers  ICMJE 0403006
0403006 ( Other Identifier: protocol id )
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 University of Pittsburgh
Collaborators  ICMJE
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • University of North Carolina
Investigators  ICMJE
Principal Investigator: Margaret V. Ragni, MD, MPH University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date May 2016

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