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The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A patients undergoing surgery.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antihemophilic factor, recombinant, manufactured protein-free | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants experiencing treatment-related adverse experiences (AEs) | Throughout the study period of approximately 3.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children´s Hospital Los Angeles, Hemophilia Comprehensive Care Center, Division of Pediatric Hematology/Oncology | Los Angeles | California | 90027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19216617 | Derived | Shapiro A, Gruppo R, Pabinger I, Collins PW, Hay CR, Schroth P, Casey K, Patrone L, Ehrlich H, Ewenstein BM. Integrated analysis of safety and efficacy of a plasma- and albumin-free recombinant factor VIII (rAHF-PFM) from six clinical studies in patients with hemophilia A. Expert Opin Biol Ther. 2009 Mar;9(3):273-83. doi: 10.1517/14712590902729392. |
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| Children´s Healthcare of Atlanta Blood Bank | Atlanta | Georgia | 30322 | United States |
| Indiana Hemophilia & Thrombosis Center | Indianapolis | Indiana | 46260 | United States |
| University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics | Iowa City | Iowa | 52242 | United States |
| Brigham and Women´s Hospital, Hematology Division | Boston | Massachusetts | 02115 | United States |
| Michigan State University | East Lansing | Michigan | 48824 | United States |
| Mt. Sinai Medical School, Hemophilia Comprehensive Care Center | New York | New York | 10029 | United States |
| Children´s Hospital Medical Center Pharmacy, Hemophilia Treatment Center | Cincinnati | Ohio | 45229 | United States |
| Hemophilia Center of Western Pennsylvania | Pittsburgh | Pennsylvania | 15213-4306 | United States |
| Puget Sound Blood Center | Seattle | Washington | 98104-1256 | United States |
| 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 |
| 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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