Study Stopped
Recruitment slow as single center conducting in rare disease
IL-11 in Adults With Von Willebrand Disease Undergoing Surgery
Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease Undergoing Surgery
1 other identifier
interventional
3
1 country
1
Brief Summary
The purpose of this study is to determine the efficacy and safety of rhIL-11 when given subcutaneously in adults with type 1 von Willebrand disease undergoing elective surgery or major dental procedure. Efficacy will be measured by estimated blood loss, and frequency and severity of bleeding and transfusion requirement during and after surgery. Safety will be measured by the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2007
CompletedFirst Posted
Study publicly available on registry
September 3, 2007
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
November 7, 2014
CompletedJune 11, 2019
June 1, 2019
4.3 years
August 31, 2007
July 22, 2014
June 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Volume of Surgical Blood Loss
Hemostatic efficacy was measured by estimated blood loss (cc) during the surgical procedure.
4 weeks
Volume of Blood Transfusion
The volume of blood transfusion required (units of blood) after the surgical procedure.
4 weeks
Secondary Outcomes (2)
No. of Subjects With Detectable VWFmRNA (Von Willebrand Factor Messenger RNA).
4 weeks per subject
Number of Subjects Who Experienced Adverse Events
The time frame is within 4 weeks of surgery.
Study Arms (1)
Neumega (Interleukin 11, IL-11)
EXPERIMENTALNeumega (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
Interventions
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
Eligibility Criteria
You may qualify if:
- Males and females 18 years of age and older
- Confirmed type 1 VWD, as defined by low VWF:RCoF or low VWF:Ag and qualitatively normal VWF multimers
- A past bleeding history
- Responsive to DDAVP
- Scheduled elective major surgery or major dental surgery at MUH or PUH
- Willingness to have blood drawn
You may not qualify if:
- Presence of other bleeding disorders, acquired Von Willebrand disease, primary thrombocytopenia
- Use of immunomodulatory or experimental drugs, or diuretics
- Pregnant or lactating women or those unwilling to use contraception during study
- Previous 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 substantial quantities of FVIII and/or VWF within five days of study
- 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 substantial quantities of FVIII and/or VWF within five days of study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Margaret Ragnilead
- University of North Carolinacollaborator
- Wyeth is now a wholly owned subsidiary of Pfizercollaborator
Study Sites (1)
Hemophilia Center of Western PA
Pittsburgh, Pennsylvania, 15213-4306, United States
Related Publications (2)
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).
BACKGROUNDRagni MV, Jankowitz RC, Chapman HL, Merricks EP, Kloos MT, Dillow AM, Nichols TC. A phase II prospective open-label escalating dose trial of recombinant interleukin-11 in mild von Willebrand disease. Haemophilia. 2008 Sep;14(5):968-77. doi: 10.1111/j.1365-2516.2008.01827.x. Epub 2008 Aug 1.
PMID: 18680527BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
There were too few subjects for reporting in a manuscript.
Results Point of Contact
- Title
- Dr. Margaret Ragni, Professor of Medicine
- Organization
- University of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
Margaret V Ragni, MD, MPH
University of Pittsburgh Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 31, 2007
First Posted
September 3, 2007
Study Start
February 1, 2008
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
June 11, 2019
Results First Posted
November 7, 2014
Record last verified: 2019-06