drugset / Trial / NCT03276143
FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study was to compare the study drug BAY1213790 to existing therapies, i.e. enoxaparin or apixaban, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA). The study was open-label, but observer-blinded for the different doses of BAY1213790. This means that it was known which treatment was given, but it was not known which dose of BAY1213790 was administered.
Timeline
- Start
- 2017-09-21
- Primary completion
- 2018-08-20
- Completion
- 2019-01-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Apixaban | Small molecule | 2.5 mg | Oral |
| Comparator | Enoxaparin sodium | Other / unclassified | 40 mg | Subcutaneous |
| Subject | Osocimab | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | Osocimab | Monoclonal antibody | 0.6 mg/kg | Intravenous |
| Subject | Osocimab | Monoclonal antibody | 1.2 mg/kg | Intravenous |
| Subject | Osocimab | Monoclonal antibody | 1.8 mg/kg | Intravenous |