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| ID | Type | Description | Link |
|---|---|---|---|
| KG110FR | Other Identifier | Company internal |
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OPTIMS is a non interventional validation study of the calculator developed by Bayer for clinician's use in the prophylactic treatment by factor VIII of patients with severe or moderate Haemophilia A with a severe clinical profile.
The study takes place during a single visit, at the time of patient enrollment in the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Factor VIII (Kogenate FS, BAY14-2222) | Drug | Prophylactic treatment : 20-40 UI /Kg administered all 2 in 3 days . |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference of the recovery rate calculated by the physician and the recovery rate calculated by an independent calculator With OPTIMS Tool | after 1 month | |
| The difference of the elimination half-life calculated by the physician and the ones calculated by an independent calculator With OPTIMS Tool | after 1 month | |
| The difference of the clearance calculated by the physician and the ones calculated by an independent calculator With OPTIMS Tool | after 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| The dosage of factor VIII calculated by OPTIMS calculator | within 48 hours after enrollment | |
| The practicality of the OPTIMS calculator by a physician's satisfaction questionnaire | within 48 hours after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | France | |||||
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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 |
|---|---|
| D005169 | Factor VIII |
| C078147 | F8 protein, human |
| C414350 | BAY 14-2222 |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Many Locations |
| Italy |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011498 |
| Protein Precursors |
| D001685 | Biological Factors |