Apixaban for the Acute Treatment of Venous Thromboembolism in Children
To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.
- Venous Thromboembolism
- Eligible Ages
- Under 17 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 28 days to <18 years of age with a minimum weight of 4 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 for at least 5 days.
- Anticoagulant treatment for the index VTE for greater than 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.)
- Phase 4
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
|Subjects between 28 days to <18 years will be dosed on a body weight tiered regimen. Subjects > or = 35 kg will receive 10 mg twice daily for 7 days followed by 5 mg twice daily thereafter;<35 kg to 25 kg will receive 8 mg twice daily for 7 days followed by 4 mg twice daily thereafter; <25 to 18 kg will receive 6 mg twice daily for 7 days and then 3mg twice daily thereafter; <18 to 12 kg will receive 4 mg twice daily for 7 days and then 2 mg twice daily thereafter; <12 to 9 kg will receive 3 mg twice daily for 7 days and then 1.5 mg twice daily thereafter; <9 kg to 6 kg will receive 2 mg twice daily for 7 days and 1 mg twice daily thereafter; <6 kg to 5 kg will receive 1 mg twice daily for 7 days and 0.5 mg twice daily thereafter; <5 kg to 4 kg will receive 0.6 mg twice daily for 7 days and 0.3 mg twice daily thereafter.||
Standard of Care
|Subjects will receive a dose and dosing regimen of anticoagulation treatment based on usual and customary care per local practices.||
Study ContactPfizer CT.gov Call Center