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The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemophilia A.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReFacto AF | Genetic | |||
| B-Domain deleted Recombinant Factor VIII | Genetic | |||
| BDDrFVIII | Genetic |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the incidence rate of Factor VIII inhibitors in the study patient population.To establish bioequivalence of ReFacto AF as compared to Advate using the one stage Factor VIII activity assay. |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the efficacy of ReFActo AF in preventing and treating bleeding episodes during prophylaxis.To characterize PK of ReFacto AF as compared to Advate over time. |
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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 Australia, New Zealand, medinfo@wyeth.com | Principal Investigator |
| Trial Manager | For Netherlands, trials-NL@wyeth.com | Principal Investigator |
| Trial Manager | For Sweden, Finland,MedInfoNord@wyeth.com | Principal Investigator |
| Trial Manager | For Hungary, WPBUMED@wyeth.com | Principal Investigator |
| Trial Manager | For Poland, WVWZMED@wyeth.com | Principal Investigator |
| Trial Manager | For Belgium, trials-BEL@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85016 | United States | |||
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| Sacramento |
| California |
| 95817 |
| United States |
| San Diego | California | 92123 | United States |
| Aurora | Colorado | 80045 | United States |
| Atlanta | Georgia | 30322 | United States |
| Iowa City | Iowa | 52242 | United States |
| New Orleans | Louisiana | 70112 | United States |
| Worcester | Massachusetts | 01605 | United States |
| East Lansing | Michigan | 48823 | United States |
| St Louis | Missouri | 63014 | United States |
| New Brunswick | New Jersey | 08903-0019 | United States |
| Buffalo | New York | 14215 | United States |
| New Hyde Park | New York | 11040 | United States |
| Chapel Hill | North Carolina | 27599 | United States |
| Dayton | Ohio | 45404 | United States |
| Hershey | Pennsylvania | 17033 | United States |
| Philadelphia | Pennsylvania | United States |
| Nashville | Tennessee | 37232 | United States |
| Houston | Texas | 77030 | United States |
| Salt Lake City | Utah | 84113 | United States |
| Charlottesville | Virginia | 22908 | United States |
| Perth | 6000 | Australia |
| Leuven | 3000 | Belgium |
| Helsinki | 00029 | Finland |
| Le Kremlin-Bicêtre | 94275 | France |
| Rouen | 76031 | France |
| Berlin | 10249 | Germany |
| Münster | 48143 | Germany |
| Budapest | H-1135 | Hungary |
| Milan | 20122 | Italy |
| Groningen | Netherlands |
| Auckland | New Zealand |
| Hamilton | New Zealand |
| Lodz | 95-510 | Poland |
| Poznan | Poland |
| Warsaw | 00-576 | Poland |
| Wroclaw | Poland |
| Madrid | 28046 | Spain |
| Valencia | 46009 | Spain |
| Malmö | Sweden |
| Stockholm | 171 76 | Sweden |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D005169 | Factor VIII |
| C427184 | recombinant factor VIII SQ |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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