drugset / Trial / NCT04789954
Study on the Dose-response Relationship of Pharmacodynamic Parameters in Patients With Hemophilia With Inhibitors
RandomizedCrossoverQuadruple-blindTreatment
Summary
Randomized, double-blind, single-dose, 5 ways crossover, exploratory clinical trial evaluating four different doses of AryoSeven (eptacog alfa, activated) and NovoSeven on selected pharmacodynamic parameters in patients with hemophilia with inhibitors.
Timeline
- Start
- 2020-12-29
- Primary completion
- 2021-08-13
- Completion
- 2022-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eptocag alfa, activated | Protein / enzyme biologic | 10 ug/kg | Intravenous |
| Subject | Eptocag alfa, activated | Protein / enzyme biologic | 30 ug/kg | Intravenous |
| Subject | Eptocag alfa, activated | Protein / enzyme biologic | 90 ug/kg | Intravenous |
| Subject | Eptocag alfa, activated | Protein / enzyme biologic | 270 ug/kg | Intravenous |