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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00623480 |
To evaluate the effect of secondary prophylaxis on bleeding frequency (number of bleeds per year) and on joint damage compared to episodic treatment.
Condition | Intervention | Phase |
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Hemophilia A |
Drug: Recombinant Anti-hemophilic Factor VIII (Kogenate®FS) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Controlled, Parallel, Prospective Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult Subjects Compared to That of Episodic Treatment. (SPINART) |
Estimated Enrollment: | 80 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 2: Experimental |
Drug: Recombinant Anti-hemophilic Factor VIII (Kogenate®FS)
Treated according to the Kogenate®FS package insert indications and study physician recommendations.
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Arm 1: Experimental |
Drug: Recombinant Anti-hemophilic Factor VIII (Kogenate®FS)
Three times per week administration of 25 IU/kg of Kogenate®FS. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) exhibiting a bleeding frequency of 12 bleeding episodes per year or greater
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com | |
Contact: For trial location information (Phone Menu Options '3' or '4') | (+)1-888-84 22937 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer HealthCare Pharmaceuticals Inc. ( Therapeutic Area Head ) |
Study ID Numbers: | 12800, EudraCT: 2008-000985-21, SPINART |
Study First Received: | February 4, 2008 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00623480 |
Health Authority: | United States: Food and Drug Administration |
Hemophilia A Prophylaxis Secondary prophylaxis |
Hemorrhagic Disorders Genetic Diseases, Inborn Hematologic Diseases Blood Coagulation Disorders |
Hemophilia A Neoplasm Metastasis Hemostatic Disorders Factor VIII |
Blood Coagulation Disorders, Inherited Coagulants Coagulation Protein Disorders |
Therapeutic Uses Hematologic Agents Pharmacologic Actions |