IL-11 in Adults With Von Willebrand Disease Undergoing Surgery
This study has been terminated.
(Recruitment slow as single center conducting in rare disease)
Sponsor:
University of Pittsburgh
Collaborators:
University of North Carolina
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Margaret Ragni, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00524225
First received: August 31, 2007
Last updated: August 5, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Von Willebrand Disease |
Drug: Neumega (Oprelvekin, Interleukin 11, IL-11) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease Undergoing Surgery |
Resource links provided by NLM:
Genetics Home Reference related topics:
von Willebrand disease
Drug Information available for:
Oprelvekin
U.S. FDA Resources
Further study details as provided by University of Pittsburgh:
Primary Outcome Measures:
- The primary efficacy outcome measure is perioperative estimated blood loss. [ Time Frame: The time frame is within 4 weeks of surgery. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- A secondary outcome measure is the mechanism of IL-11 effect by VWFmRNA. [ Time Frame: 4 weeks per subject ] [ Designated as safety issue: No ]
- A secondary outcome measure is the frequency of IL-11 associated adverse events. [ Time Frame: The time frame is within 4 weeks of surgery. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 10 |
| Study Start Date: | February 2008 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
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
Other Name: Neumega (Oprelvekin, Interleukin 11, IL-11)
|
Detailed Description:
This study is a prospective, single-center Phase II trial of Neumega (rhIL-11) in adults with type 1 VWD undergoing elective surgery or major dental procedure. It is anticipated that 10 subjects who meet eligibility criteria will enroll and complete the study. The specific objectives are to determine the efficacy and safety or rhIL-11 during and after elective surgery, and to determine the mechanism of the hemostatic response of rhIL-11.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524225
Locations
| United States, Pennsylvania | |
| Hemophilia Center of Western PA | |
| Pittsburgh, Pennsylvania, United States, 15213-4306 | |
Sponsors and Collaborators
University of Pittsburgh
University of North Carolina
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Principal Investigator: | Margaret V Ragni, MD, MPH | University of Pittsburgh |
More Information
Publications:
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).
| Responsible Party: | Margaret Ragni, Laurel Yasko, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00524225 History of Changes |
| Other Study ID Numbers: | PRO07030210 |
| Study First Received: | August 31, 2007 |
| Last Updated: | August 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Pittsburgh:
|
IL-11 von Willebrand disease von Willebrand factor VWFmRNA surgery |
Additional relevant MeSH terms:
|
Von Willebrand Diseases Von Willebrand Disease, Type 1 Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases Coagulation Protein Disorders Blood Platelet Disorders |
Hemorrhagic Disorders Genetic Diseases, Inborn Oprelvekin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013