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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00621673 |
Most transient inhibitor formation, if any, will develop within the first 4 weeks. The study is to further monitor whether participants with severe Hemophilia A will develop inhibitors or antibodies at the later stage when switched from their current recombinant therapy produced from Chinese Hamster Ovary (CHO) cell line to Kogenate®-FS raised in a Baby Hamster Kidney cell line.
Condition | Intervention | Phase |
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Hemophilia A |
Drug: Kogenate (BAY 14-2222) |
Phase IV |
Study Type: | Interventional |
Study Design: | Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Assessment of the Risk of Inhibitor Formation in Subjects With Severe Hemophilia A When Switched From a Replacement Therapy With a rFVIII Produced by a Chinese Hamster Ovary (CHO) Cell Line to a rFVIII Produced by a Baby Hamster Kidney (BHK) Cell Line (Kogenate® FS). |
Enrollment: | 4 |
Study Start Date: | May 2006 |
Study Completion Date: | October 2006 |
Arms | Assigned Interventions |
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Arm 1
n/a
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Drug: Kogenate (BAY 14-2222)
Antihemophilic factor (recombinant) 20-40 IU/ kg based on body weight of rFVIII, IV, 3 times a week
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Ages Eligible for Study: | 10 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Michigan | |
Detroit, Michigan, United States, 48202 | |
United States, Nevada | |
Las Vegas, Nevada, United States, 89109 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | ( Bayer HealthCare AG, Therapeutic Area Head ) |
Study ID Numbers: | 12112 |
Study First Received: | February 12, 2008 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00621673 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Hemophila A, Inhibitor formation, rFVIII |
Hemorrhagic Disorders Genetic Diseases, Inborn Hematologic Diseases Blood Coagulation Disorders |
Hemophilia A Hemostatic Disorders Factor VIII |
Blood Coagulation Disorders, Inherited Coagulation Protein Disorders |