A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150 (Q63839171)
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clinical trial
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150 |
clinical trial |
Statements
A Phase 2/3, Multicenter, Open-label Clinical Study to Assess the Safety and Efficacy of BAY86-6150 in Subjects With Hemophilia A or B With Inhibitors, Composed of 2 Parts (A & B). Part A: Sequential Cohorts of Four Dose Levels of the Modified rFVIIa BAY86-6150 Assessed in a Non-controlled Dose Response Design in Acutely Bleeding Subjects and for PK/ PD in an Intra-individual Crossover Design Compared With One Fixed Dose of Eptacog Alfa in Non-bleeding Subjects. Part B: Confirmatory Study to Further Investigate the Efficacy and Safety of BAY86-6150 (English)
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June 2012
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March 2014
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10
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12 year
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62 year
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