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Sponsors and Collaborators: |
University of Pittsburgh Wyeth University of North Carolina |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00151125 |
This study is testing the use of rhIL-11 (recombinant interleukin 11, Neumega) in individuals with Von Willebrand disease. The purpose is to evaluate:
Condition | Intervention | Phase |
---|---|---|
Von Willebrand Disease |
Drug: recombinant interleukin-11 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Comparison Study of Hemostatic Efficacy of Escalating Doses of Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease |
Enrollment: | 12 |
Study Start Date: | July 2004 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
rhIL-11 (Interleukin-11, Neumega) 25 mcg/kg subcutaneously daily for 7 days
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Drug: recombinant interleukin-11
25 mcg/kg subcutaneously daily for seven days
|
B: Experimental
rhIL-11 (interleukin-11, Neumega) 50 mcg/kg subcutaneously daily for 7 days
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Drug: recombinant interleukin-11
50 mcg/kg subcutaneously daily for 7 days
|
C: Experimental
rhIL-11 (Interleukin-11, Neumega) 10 mg/kg subcutaneously daily for 7 days
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Drug: recombinant interleukin-11
10 mcg/kg subcutaneously daily for 7 days
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This is a prospective, single center, open-label, escalating dose Phase II comparison study of interleukin-11 (rhIL-11, Neumega) in subjects with type 1 Von Willebrand Disease (VWD).
The purpose is to establish the clinical safety and hemostatic efficacy of rhIL-11 in individuals with type 1 Von Willebrand disease.
Study subjects will include the following subjects:
A total of 10-16 subjects are anticipated to be enrolled and complete the study. The specific aims of the study are:
Efficacy will be based on the number and percent increase of VWD-related coagulation tests into the normal range, or at least to 2-3 times baseline.
Safety will be based on the number and frequency of adverse reactions, including fever, headache, fatigue, arthralgias, myalgias, fluid retention, and edema.
The study will last up to 4 weeks per subject, and for 24 months for the entire study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Hemophilia Center of Western Pennsylvania and General Clinical Research Center | |
Pittsburgh, Pennsylvania, United States, 15213-4306 |
Principal Investigator: | Margaret V. Ragni, MD, MPH | University of Pittsburgh |
Responsible Party: | University of Pittsburgh ( Margaret V. Ragni, MD, MPH, Principal Investigator, Professor of Medicine ) |
Study ID Numbers: | 0403006, (none) |
Study First Received: | September 6, 2005 |
Last Updated: | February 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00151125 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Von Willebrand Disease Bleeding Coagulation Hemostatic agent |
Von Willebrand Disease Thrombocytopathy Oprelvekin Hemorrhagic Disorders Genetic Diseases, Inborn Hematologic Diseases |
Blood Platelet Disorders Blood Coagulation Disorders Hemostatic Disorders Hemorrhage Hemostatics |
Von Willebrand Disease Coagulants Antineoplastic Agents Hematologic Diseases Coagulation Protein Disorders Blood Coagulation Disorders Blood Platelet Disorders Hematologic Agents |
Pharmacologic Actions Hemostatics Blood Coagulation Disorders, Inherited Hemorrhagic Disorders Oprelvekin Genetic Diseases, Inborn Therapeutic Uses |