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EINSTEIN Jr: Rivaroxaban for Pediatric VTE
NCT02234843Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2014
- Primary completion
- Jan 2019
- Countries
- 28
- Sponsor
- Bayer
- Modality
- Small Molecules
- Drugs
- rivaroxaban
- Conditions
- venous thromboembolism (VTE)
01
Overview
Phase 3, randomised, open-label trial in venous thromboembolism (VTE) comparing Rivaroxaban with Standard of Care (2 arms). Primary endpoints: Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism at 1 month, Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding at 1 month and 1 more. Started Nov 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Rivaroxaban
Body weight-adjusted rivaroxaban (tablets or suspension)
Standard of Care
LMWH, fondaparinux, or VKA
03
Who it enrols
Children aged birth to <18 years with confirmed acute venous thromboembolism who have received initial parenteral anticoagulation for 5-9 days.
04
Endpoints
Primary
Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism
Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding
Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period
Secondary
Incidence Rates of the Composite of All Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging
AUC(0-24)ss in Plasma
Cmax,ss in Plasma
05
Results
Not all primary endpoints met
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