Apixaban for the Acute Treatment of Venous Thromboembolism in Children

Inclusion Criteria

• Birth to <18 years of age with a minimum weight of 2.6 kg at the time of randomization.
• Presence of an index VTE which is confirmed by imaging.
• Intention to manage the index VTE with anticoagulation treatment for at least 6 to 12 weeks.
• Subjects able to tolerate oral feeding, nasogastric (NG), gastric (G) feeding and are currently tolerating enteric medications, as per investigator's judgement.

Exclusion Criteria

• Anticoagulant treatment for the index VTE for greater than 14 days prior to randomization. Neonates that are enrolled into the PK cohort must be on a minimum of 5 days and a maximum of 14 days SOC anticoagulation prior to randomization. Neonates that are enrolled into the post PK cohort may receive SOC anticoagulation for up to 14 days prior to randomization.
• Thrombectomy, thrombolytic therapy, or insertion of a caval filter to treat the index VTE.
• A mechanical heart valve.
• Active bleeding or high risk of bleeding at the time of randomization.
• Intracranial bleed, including intraventricular hemorrhage, within 3 months prior to randomization.
• Abnormal baseline liver function at randomization.
• Inadequate renal function at the time of randomization.
• Platelet count <50×109 per L at randomization.
• Uncontrolled severe hypertension at the time of randomization.
• Use of prohibited concomitant medication at the time of randomization.
• Female subjects who are either pregnant or breastfeeding a child.
• Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment.
• Unable to take oral or enteric medication via the NG or G tube.
• Known inherited or acquired antiphospholipid syndrome (APS).
• Known inherited bleeding disorder or coagulopathy with increased bleeding risk (eg, hemophilia, von Willebrand disease, etc.)