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

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ClinicalTrials.gov Identifier: NCT00524342
Recruitment Status : Completed
First Posted : September 3, 2007
Results First Posted : November 7, 2014
Last Update Posted : January 31, 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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Von Willebrand Disease
Intervention: Drug: Oprelvekin, Interleukin 11, IL-11

  Participant Flow

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

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.
No text entered.

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 
Overall Participants Analyzed 
[Units: Participants]
 7 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      7 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      7 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   7 


  Outcome Measures

1.  Primary:   >50% Reduction in PBAC (Pictorial Blood Assessment Chart) at 6 Months   [ Time Frame: 6 months ]

2.  Secondary:   No. of Subjects With Detectable VWF mRNA (Von Willebrand Factor Messenger RNA).   [ Time Frame: The time frame is up to 7 months per subject. ]

3.  Secondary:   No. of Subjects With IL-11 Associated Adverse Events.   [ Time Frame: The time frame is up to 7 months per subject. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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:

Responsible Party: Margaret Ragni, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00524342     History of Changes
Other Study ID Numbers: PRO07040157
Wyeth 102344 ( Other Identifier: Wyeth )
First Submitted: August 31, 2007
First Posted: September 3, 2007
Results First Submitted: June 4, 2014
Results First Posted: November 7, 2014
Last Update Posted: January 31, 2018