We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00524342
First Posted: September 3, 2007
Last Update Posted: September 18, 2017
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.
Collaborators:
University of North Carolina
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Margaret Ragni, University of Pittsburgh
Results First Submitted: June 4, 2014  
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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

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



  Baseline Characteristics
  Hide 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
  Show All Outcome Measures

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.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide 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: September 18, 2017