Multicenter, open-label, active-controlled, randomized study to evaluate the efficacy and safety of an age-and body weight-adjusted rivaroxaban regimen compared to standard of care in children with acute venous thromboembolism
- Conditions
- blood clotthrombosis10064477
- Registration Number
- NL-OMON47378
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
1. - Children aged birth to < 18 years with confirmed venous thromboembolism who receive initial treatment with therapeutic dosages of UFH, LMWH or fondaparinux and require anticoagulant therapy for at least 90 days. However, children aged birth to < 2 years with catheter-related thrombosis require anticoagulant therapy for at least 30 days.
For children younger than 6 months:
- Gestational age at birth of at least 37 weeks.
- Oral feeding/nasogastric/gastric feeding for at least 10 days.
- Body weight *2600 g ;2. Informed consent provided and, if applicable, child assent provided
1. Active bleeding or bleeding risk contraindicating anticoagulant therapy;2. An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 ;3. Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase (ALT) > 5x upper level of normal (ULN) or total bilirubin (TB) > 2x ULN with direct bilirubin > 20% of the total;4. Platelet count < 50 x 109/L;5. Sustained uncontrolled hypertension defined as systolic and/or diastolic blood pressure > 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 ;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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Assessment of incidence of symptomatic recurrent venous thromboembolism.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Assessment of all symptomatic recurrent venous thromboembolism and<br /><br>asymptomatic deterioration on repeat imaging<br /><br>- Assessment of the incidence of over major and clinically relevant non major<br /><br>bleeding<br /><br>- Characterize the pharmacokinetic/pharmacodynamics profile of rivaroxaban</p><br>