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Sponsored by: |
CSL Behring |
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Information provided by: | CSL Behring |
ClinicalTrials.gov Identifier: | NCT00168090 |
The purpose of this study is to test the safety and effectiveness of Humate-P® to prevent bleeding in patients with von Willebrand Disease who are undergoing surgery.
Condition | Intervention | Phase |
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Von Willebrand Disease Blood Coagulation Disorders Blood Platelet Disorders Hematologic Disease |
Drug: Blood coagulation Factor VIII and vWF, human |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects With Von Willebrand's Disease. |
Estimated Enrollment: | 30 |
Study Start Date: | October 2001 |
Estimated Study Completion Date: | May 2006 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
United States, Wisconsin | |
Milwaukee, Wisconsin, United States, 53201-2178 |
Principal Investigator: | Marylin J. Manco-Johnson, M.D. | Mountain States Regional Hemophilia Center, Aurora, Columbia, U.S. |
Study ID Numbers: | AP7000/1-4002 |
Study First Received: | September 12, 2005 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00168090 History of Changes |
Health Authority: | United States: Food and Drug Administration |
von Willebrand Factor Blood Coagulation Disorders Factor VIII |
Von Willebrand Disease Thrombocytopathy Hemorrhagic Disorders Genetic Diseases, Inborn Hematologic Diseases Blood Platelet Disorders |
Blood Coagulation Disorders Hemophilia A Vascular Diseases Hemostatic Disorders Factor VIII |
Von Willebrand Disease Disease Coagulants Hematologic Diseases Coagulation Protein Disorders Blood Coagulation Disorders Blood Platelet Disorders Hematologic Agents Hemophilia A Vascular Diseases |
Hemostatic Disorders Pharmacologic Actions Factor VIII Hemorrhagic Disorders Pathologic Processes Blood Coagulation Disorders, Inherited Genetic Diseases, Inborn Therapeutic Uses Cardiovascular Diseases |