Venous Thromboembolism MedDRA version: 21.1 Level: LLT Classification code 10043565 Term: Thromboembolic event System Organ Class: 100000004866
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Children from birth to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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. 2. Cerebral sinovenous thrombosis (in Germany only). 3. Thrombectomy, thrombolytic therapy, or insertion of a caval filter to treat the index VTE. 4. A mechanical heart valve. 5. Active bleeding or high risk of bleeding (eg, central nervous system (CNS) tumors) at the time of randomization. 6. Intracranial bleed, including intraventricular hemorrhage, within 3 months prior to randomization. 7. Abnormal baseline liver function (ALT >3 x upper limit of normal (ULN) or conjugated bilirubin >2 x ULN) at randomization. 8. At the time of randomization, inadequate renal function as defined in Section 7.2.2. Estimated Glomerular Filtration Rate Assessment. 9. Platelet count <50×109 per L at randomization. 10. At the time of randomization, uncontrolled severe hypertension as defined in Section 7.1 Physical Examination. 11. At the time of randomization, use of prohibited concomitant medication as listed for apixaban in Section 5.5 Concomitant Medication. 12. Known allergy to apixaban or any of the other ingredients in the apixaban formulation, or hypersensitivity to any of the components of the comparators. 13. Female subjects who are either pregnant or breastfeeding a child. 14. Geographically unavailable for follow-up. 15. Family members who are either investigational site staff members directly involved in the conduct of this trial or site staff members otherwise supervised by theInvestigator. Family members who are Pfizer or Bristol Myers Squibb (BMS) employees directly involved in the conduct of this trial. 16. Taking an investigational drug in other studies within 30 days before the first dose of apixaban and/or during study participation. N.B. using marketed medications commonly used in usual and customary practice, though not labeled for use in children, is acceptable. 17. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 18. Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment. 19. Unable to take oral or enteric medication via the NG or G tube. 20. Known inherited or acquired antiphospholipid syndrome (APS). 21. Known inherited bleeding disorder or coagulopathy with increased bleeding risk (eg, hemophilia, von Willebrand disease, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and extrapolated efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.;Secondary Objective: To evaluate apixaban pharmacokinetic (PK) and anti-FXa activity in pediatric subjects requiring anticoagulation for the treatment of a VTE.;Primary end point(s): Primary Safety: The composite of major and clinically relevant non-major bleeding. Primary Efficacy: A composite of: (i) all image-confirmed and adjudicated symptomatic and asymptomatic recurrent VTE defined as either contiguous progression or non-contiguous new thrombus and including but not limited to, DVT, PE and paradoxical embolism and (ii) VTE-related mortality. ;Timepoint(s) of evaluation of this end point: Listed with Endpoints | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • All cause death • Index VTE status (e.g. progression, regression, or resolution) • Stroke • New symptomatic or asymptomatic DVT • New symptomatic PE • Apixaban concentrations • Anti-FXa activity;Timepoint(s) of evaluation of this end point: Listed with endpoints | — |
Countries
Australia, Austria, Canada, France, Germany, Israel, Italy, Mexico, Poland, Portugal, Russian Federation, Spain, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactGCT-SU Representative
Bristol-Myers Squibb International Corporation
Outcome results
None listed