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IL-11 in Women With Von Willebrand Disease and Refractory Menorrhagia

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00524342
First received: August 31, 2007
Last updated: November 5, 2014
Last verified: November 2014
Results First Received: June 4, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Von Willebrand Disease
Intervention: Drug: Neumega (Oprelvekin, Interleukin 11, IL-11)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
IL-11 Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles

Participant Flow:   Overall Study
    IL-11  
STARTED     7  
COMPLETED     7  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
IL-11 Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles

Baseline Measures
    IL-11  
Number of Participants  
[units: participants]
  7  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     0  
Gender  
[units: participants]
 
Female     7  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     7  



  Outcome Measures
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1.  Primary:   >50% Reduction in PBAC at 6 Months   [ Time Frame: 6 months ]

2.  Secondary:   A Secondary Outcome Measure is the Frequency of IL-11 Associated Adverse Events.   [ Time Frame: The time frame is up to 7 months per subject. ]

3.  Secondary:   A Secondary Outcome Measure is the Mechanism of IL-11 Effect by VWF mRNA.   [ Time Frame: The time frame is up to 7 months per subject. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Margaret Ragni
Organization: University of Pittsburgh
phone: 412-209-7288
e-mail: ragni@dom.pitt.edu


Publications of Results:
Other Publications:
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).


Responsible Party: Margaret Ragni, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00524342     History of Changes
Other Study ID Numbers: PRO07040157, Wyeth 102344
Study First Received: August 31, 2007
Results First Received: June 4, 2014
Last Updated: November 5, 2014
Health Authority: United States: Food and Drug Administration