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| Sponsor: | University of Pittsburgh |
|---|---|
| Collaborators: |
University of North Carolina Wyeth is now a wholly owned subsidiary of Pfizer |
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00524225 |
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 II |
| 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 |
| Estimated Enrollment: | 10 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 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)
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Margaret V Ragni, MD, MPH | 412-209-7288 | ragni@dom.pitt.edu |
| Contact: Kristen Jaworski, RN | 412-209-7411 | kjaworski@itxm.org |
| United States, Pennsylvania | |
| Hemophilia Center of Western PA | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213-4306 | |
| Contact: Margaret V Ragni, MD, MPH 412-209-7288 ragni@dom.pitt.edu | |
| Contact: Kristen Jaworski, RN 412-209-7411 kjaworski@itxm.org | |
| Principal Investigator: Margaret V Ragni, MD, MPH | |
| Principal Investigator: | Margaret V Ragni, MD, MPH | University of Pittsburgh |
More Information
| Responsible Party: | Margaret V. Ragni, MD, MPH, Principal Investigator, Professor of Medicine, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00524225 History of Changes |
| Other Study ID Numbers: | PRO07030210 |
| Study First Received: | August 31, 2007 |
| Last Updated: | July 25, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
IL-11 von Willebrand disease von Willebrand factor VWFmRNA surgery |
|
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 |