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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002011-28 | EudraCT Number |
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| Name | Class |
|---|---|
| Baxter Innovations GmbH | INDUSTRY |
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The objectives of this study are to assess the tolerability and safety after single dose treatments of BAX 855 in previously treated patients (PTPs) with severe hemophilia A, to determine the pharmacokinetic (PK) parameters of BAX 855 compared in crossover with ADVATE, and to evaluate the impact of anti-polyethylene glycol (PEG) antibodies on PK parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Low dose of ADVATE followed by low dose of BAX 855 |
|
| Cohort 2 | Experimental | High dose of ADVATE followed by high dose of BAX 855 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method | Biological | 1 PK infusion of ADVATE (low dose in Cohort 1, high dose in Cohort 2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious and non-serious AEs | 4 weeks after infusion with BAX 855 and ADVATE |
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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 |
|---|---|---|---|---|---|---|
| Specialized Hospital for Active Treatment "Joan Pavel" | Sofia | 1233 | Bulgaria | |||
| Vivantes Klinikum im Friedrichshain, Hemophilia Care Center for Children and Adults |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26157075 | Derived | Konkle BA, Stasyshyn O, Chowdary P, Bevan DH, Mant T, Shima M, Engl W, Dyck-Jones J, Fuerlinger M, Patrone L, Ewenstein B, Abbuehl B. Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia A. Blood. 2015 Aug 27;126(9):1078-85. doi: 10.1182/blood-2015-03-630897. Epub 2015 Jul 8. |
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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 |
| C000609799 | BAX 855 |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| PEGylated Recombinant Factor VIII | Biological | 1 PK infusion of BAX 855 (low dose in Cohort 1, high dose in Cohort 2) |
|
|
| Berlin |
| 10249 |
| Germany |
| UKGM Uniklinikum Giessen & Marburg | Giessen | 35392 | Germany |
| Harrison Clinical Research Deutschland | Munich | 80636 | Germany |
| Nara Medical University Hospital | Nara | 630-8521 | Japan |
| Tokyo Medical University Hospital | Tokyo | 160-0023 | Japan |
| Quintiles Drug Research Unit at Guy´s Hospital | London | SE1 1YR | United Kingdom |
| Manchester Haemophilia Comprehensive Care Centre, Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| 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 |