A Phase 2, Multicenter, Randomized, Open-Label, Active-Control Study of REGN9933, a Factor XI Monoclonal Antibody, for Prevention of Venous Thromboembolism after Elective, Unilateral, Total Knee Arthroplasty

Conditions

Thromboembolic disease

Brief summary

The primary endpoint is the incidence of confirmed, adjudicated venous thromboembolism (VTE) through day 12 (REGN9933 vs enoxaparin).

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 (REGN9933 versus enoxaparin)., Incidence of DVT as measured by venography of the operated leg (approximately day 12; REGN9933 vs enoxaparin)., Concentrations of REGN9933 in serum (through end of study; approximately day 75)., Change in activated partial thromboplastin time (aPTT) from baseline (through end of study; approximately day 75)., Change in prothrombin time (PT) from baseline (through end of study; approximately day 75)., Incidence of anti-drug antibodies (ADA) to REGN9933 (through end of study; approximately day 75)., Titer of anti-drug antibodies (ADA) to REGN9933 (through end of study; approximately day 75)., Incidence of confirmed, adjudicated VTE (baseline through day 12; enoxaparin vs apixaban).

Related papers

No related papers found yet.

Interventions

DRUGEliquis 2.5 mg film-coated tablets

DRUGInhixa 4

DRUG000 IU (40 mg)/0.4 mL solution for injection in pre-filled syringe

DRUGREGN9933

DRUGCLEXANE 4 000 UI (40 mg)/0

DRUG4 ml solution injectable en seringue préremplie

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the incidence of confirmed, adjudicated venous thromboembolism (VTE) through day 12 (REGN9933 vs enoxaparin).	—

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 (REGN9933 versus enoxaparin)., Incidence of DVT as measured by venography of the operated leg (approximately day 12; REGN9933 vs enoxaparin)., Concentrations of REGN9933 in serum (through end of study; approximately day 75)., Change in activated partial thromboplastin time (aPTT) from baseline (through end of study; approximately day 75)., Change in prothrombin time (PT) from baseline (through end of study; approximately day 75)., Incidence of anti-drug antibodies (ADA) to REGN9933 (through end of study; approximately day 75)., Titer of anti-drug antibodies (ADA) to REGN9933 (through end of study; approximately day 75)., Incidence of confirmed, adjudicated VTE (baseline through day 12; enoxaparin vs ap	—

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 (REGN9933 versus enoxaparin)., Incidence of DVT as measured by venography of the operated leg (approximately day 12; REGN9933 vs enoxaparin)., Concentrations of REGN9933 in serum (through end of study; approximately day 75)., Change in activated partial thromboplastin time (aPTT) from baseline (through end of study; approximately day 75)., Change in prothrombin time (PT) from baseline (through end of study; approximately day 75)., Incidence of anti-drug antibodies (ADA) to REGN9933 (through end of study; approximately day 75)., Titer of anti-drug antibodies (ADA) to REGN9933 (through end of study; approximately day 75)., Incidence of confirmed, adjudicated VTE (baseline through day 12; enoxaparin vs ap

—

Countries

Belgium, Bulgaria, Hungary, Latvia, Lithuania, Poland

Outcome results

None listed