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This investigation will utilize a systematic determination of anti-FVIII antibody specificity in PTPs (> 50 ED) with hemophilia A who have developed inhibitors in response to treatment with any FVIII product(s). A group of patients with hemophilia A, who have no evidence of current or prior FVIII inhibitor will be included for comparison. The objective of this study is to describe the patterns of antibodies and associated epitopes in the study population.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single blood draw | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the patterns of antibodies and associated epitopes in a subset of | ||
| previously treated patients with hemophilia A. |
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Inclusion Criteria:
· Patients with moderate or severe congenital hemophilia A, a current FVIII inhibitor, who have taken at least two different FVIII products during their lifetime.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trail Manager | For Italy, decresg@wyeth.com | Principal Investigator |
| Trial Manager | For Spain, MedInfoNord@wyeth.com | Principal Investigator |
| Trial Manager | For UK, ukmedinfo@wyeth.com | Principal Investigator |
| Trial Manager | For Belgium, trials-BEL@wyeth.com | Principal Investigator |
| Trial Manager | For Germany, MedInfoDEU@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta | Georgia | 30322 | United States | |||
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| Detroit |
| Michigan |
| 48201 |
| United States |
| New Hyde Park | New York | 11040 | United States |
| New York | New York | 10021 | United States |
| Philadelphia | Pennsylvania | 19134 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78207 | United States |
| Brussels | 1200 | Belgium |
| Leuven | 3000 | Belgium |
| La Bouëxière | 35340 | France |
| Le Kremlin-Bicêtre | 94275 | France |
| Lyon | 69003 | France |
| Berlin | 10249 | Germany |
| Bonn | 53105 | Germany |
| Bremen | D-28205 | Germany |
| München | 81336 | Germany |
| Münster | 48103 | Germany |
| Florence | 50134 | Italy |
| Milan | 20122 | Italy |
| Madrid | 28046 | Spain |
| Valencia | 46009 | Spain |
| London | E1 1BB | United Kingdom |
| Manchester | M13 9WL | United Kingdom |
| 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 |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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