Venous Thrombosis MedDRA version: 20.0 Level: LLT Classification code 10066899 Term: Venous thromboembolism System Organ Class: 100000004866
Conditions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 6 months to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Active bleeding or bleeding risk contraindicating anticoagulant therapy 2. An estimated glomerular filtration rate (eGFR) 5x upper level of normal (ULN) or total bilirubin (TB) > 2x ULN with direct bilirubin > 20% of the total 4. Platelet count 95th age percentile 6. Life expectancy < 3 months 7. Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), including but not limited to all human immunodeficiency virus protease Inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically (fluconazole is allowed). For exceptions, see Section 4.4 of the Study Protocol. 8. Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine 9. Childbearing potential without proper contraceptive measures, pregnancy or breast feeding 10. Hypersensitivity or any other contraindication listed in the local labeling for the comparator treatment or experimental treatment 11. Inability to cooperate with the study procedures 12. Participation in a study with an investigational drug or medical device within 30 days prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy objective is: To assess the incidence of symptomatic recurrent venous thromboembolism The principal safety objective is: ? To assess the incidence of overt major and clinically relevant non-major bleeding. ; Primary end point(s): 1. Efficacy: The composite of all symptomatic recurrent venous thromboembolism 2. Safety: The composite of overt major and clinically relevant non-major bleeding. ; Secondary Objective: The secondary efficacy objective is: To assess the incidence of symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging. An additional objective is: To characterize the pharmacokinetic / pharmacodynamics profile of rivaroxaban. ; Timepoint(s) of evaluation of this end point: 1. At the end of the main study treatment period: After 90 days of treatment and again at 30 days post Treatment (for children below 2 years + catheter related thrombosis: after 30 days of treatment and again at 30 days post Treatment) 2. At the end of main study treatment period: After 90 days of treatment and again at 30 days post Treatment (for children below 2 years + catheter related thrombosis: after 30 days of Treatment and again at 30 days post treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The composite of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging. 2. Results of pharmacokinetics (PK)/ pharmacodynamics (PD) analyses ; Timepoint(s) of evaluation of this end point: 1. After the end of main study Treatment period: After 90 days of treatment and again at 30 days post Treatment (for children below 2 years + catheter related thrombosis: after 30 days of treatment and again at 30 days post treatment) 2. PK and PD as defined in the protocol | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed