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The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate, using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReFacto | Drug | |||
| Advante | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects who experience any adverse event or develop Factor VIII inhibitor at study termination, 48 hours post dosing and/or at the final study visit within seven days of the 2nd period of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For Germany, MedInfoDEU@wyeth.com | Principal Investigator |
| Trial Manager | For Italy, descresg@wyeth.com | Principal Investigator |
| Trial Manager | For Belgium, trials-BEL@wyeth.com | Principal Investigator |
| Trial Manager | For Netherlands, trials-NL@wyeth.com | Principal Investigator |
| Trial Manager | For New Zealand, medinfo@wyeth.com | Principal Investigator |
| Trial Manager | For UK, ukmedinfo@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington D.C. | District of Columbia | 20007 | United States | |||
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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 |
|---|---|
| C427184 | recombinant factor VIII SQ |
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| Atlanta |
| Georgia |
| 30322 |
| United States |
| Iowa City | Iowa | 52242 | United States |
| New Orleans | Louisiana | 70112 | United States |
| Brussels | 1200 | Belgium |
| Paris | 75747 | France |
| Berlin | 10249 | Germany |
| Münster | 48143 | Germany |
| Milan | 20122 | Italy |
| Amsterdam | Netherlands |
| Utrecht | 3584 CX | Netherlands |
| Christchurch | 8001 | New Zealand |
| Manchester | M13 9WL | United Kingdom |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |