Thromboembolic disease
Conditions
Brief summary
Incidence of confirmed, adjudicated VTE through day 12
Detailed description
Incidence of major bleeding up to approximately day 12, Incidence of clinically relevant non-major (CRNM) bleeding up to approximately day 12, Incidence of treatment emergent adverse events (TEAEs) through end of study; approximately day 75, Incidence of major VTE through day 12, Incidence of Deep venous thrombosis (DVT) at approximately day 12, Concentrations of REGN7508 in serum through end of study; approximately day 75, Change in activated partial thromboplastin time (aPTT) baseline to end of study; approximately day 75, Change in prothrombin time (PT) baseline to end of study; approximately day 75, Incidence of anti-drug antibodies (ADA) to REGN7508 through end of study; approximately day 75, Titer of ADA to REGN7508 through end of study; approximately day 75
Interventions
Sponsors
Regeneron Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of confirmed, adjudicated VTE through day 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of major bleeding up to approximately day 12, Incidence of clinically relevant non-major (CRNM) bleeding up to approximately day 12, Incidence of treatment emergent adverse events (TEAEs) through end of study; approximately day 75, Incidence of major VTE through day 12, Incidence of Deep venous thrombosis (DVT) at approximately day 12, Concentrations of REGN7508 in serum through end of study; approximately day 75, Change in activated partial thromboplastin time (aPTT) baseline to end of study; approximately day 75, Change in prothrombin time (PT) baseline to end of study; approximately day 75, Incidence of anti-drug antibodies (ADA) to REGN7508 through end of study; approximately day 75, Titer of ADA to REGN7508 through end of study; approximately day 75 | — |
Countries
Bulgaria, Hungary, Latvia, Lithuania, Poland
Outcome results
None listed