drugset / Trial / NCT00524225
IL-11 in Adults With Von Willebrand Disease Undergoing Surgery
Phase 2
Terminated
3 enrolled
Margaret Ragni
University of North Carolina · collabWyeth is now a wholly owned subsidiary of Pfizer · collab
NaSingle-groupOpen-labelPrevention
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.
Timeline
- Start
- 2008-02
- Primary completion
- 2012-06
- Completion
- 2012-06
Outcome
Outcome not reported
Stopped (Enrollment): “Recruitment slow as single center conducting in rare disease”
Publications
- Background 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).
- Background Ragni 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oprelvekin | Protein / enzyme biologic | 25 ug/kg | Subcutaneous |