IL-11 in Adults With Von Willebrand Disease Undergoing Surgery
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|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 : March 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Von Willebrand Disease||Drug: Neumega (Oprelvekin, Interleukin 11, IL-11)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease Undergoing Surgery|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
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
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
- 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.
- 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 Participants [ Time Frame: The time frame is within 4 weeks of surgery. ]mild headache, nausea
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00524225
|United States, Pennsylvania|
|Hemophilia Center of Western PA|
|Pittsburgh, Pennsylvania, United States, 15213-4306|
|Principal Investigator:||Margaret V Ragni, MD, MPH||University of Pittsburgh|