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| ID | Type | Description | Link |
|---|---|---|---|
| 12252 - KG0201CH, | |||
| 12253 - KG0201BE, | |||
| 12256 - KG0201AT, | |||
| 12258 - KG0201IT, | |||
| 12259 - KG0201GR, | |||
| 12260 - KG0201ES, | |||
| 12261 - KG0201FR, | |||
| 12264 - KG0201SE, | |||
| 12266 - KG0201NL |
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To evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or on demand.
To evaluate both safety and efficacy with respect to lot variability, in particular regarding lot-groups formulated with or without fix between.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kogenate (BAY14-2222) | Drug | Patients with severe haemophilia A (<2% FVIII:C baseline level) treated with Kogenate Bayer as their only source of recombinant FVIII |
|
Inclusion Criteria:
Exclusion Criteria:
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Patients with severe haemophilia A (<2% FVIII:C baseline level) treated with Kogenate Bayer as their only source of recombinant FVIII
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Austria | |||||
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C078147 | F8 protein, human |
| C414350 | BAY 14-2222 |
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| Many Locations |
| Belgium |
| Many Locations | Denmark |
| Many Locations | France |
| Many Locations | Greece |
| Many Locations | Italy |
| Many Locations | Netherlands |
| Many Locations | Spain |
| Many Locations | Sweden |
| Many Locations | Switzerland |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |