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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003201-18 | EudraCT Number |
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The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after intravenous administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY94-9027 and Elocta | Experimental | Subjects received two treatments: 60 IU/kg BAY94-9027 in the first period, followed by 60 IU/kg Elocta in the second period, with a washout period before each treatment |
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| Elocta and BAY94-9027 | Experimental | Subjects received two treatments: 60 IU/kg Elocta in the first period, followed by 60 IU/kg BAY94-9027 in the second period, with a washout period before each treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Damoctocog (Jivi, BAY94-9027) | Drug | 60 international units (IU)/kg, given as a 10 minute injection, 1 dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC from time 0 to the last data point | Area under the concentration time profile curve. | Pre-Dose and up to 120 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD | Sofia | 1756 | Bulgaria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31236667 | Derived | Shah A, Solms A, Wiegmann S, Ahsman M, Berntorp E, Tiede A, Iorio A, Mancuso ME, Zhivkov T, Lissitchkov T. Direct comparison of two extended-half-life recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A. Ann Hematol. 2019 Sep;98(9):2035-2044. doi: 10.1007/s00277-019-03747-2. Epub 2019 Jun 24. |
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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 |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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Each subject will receive the two treatments. Pharmacokinetic samples will be collected from pre-dose until 120 hours after the end of the injection of the single dose in each treatment arm.
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| Elocta | Drug | 60 IU/kg, given as a 10 minute injection, 1 dose |
|
| 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 |