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

CompletadoFase 3ClinicalTrials.gov

ID: NCT02234843Tipo: INTERVENTIONALInicio: 13 de nov de 2014Fin estimado: 30 de ene de 2019

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.

Elegibilidad

Edad máxima: 17 YearsSexo: ALL

Criterios de inclusión

Children aged birth to \< 18 years with confirmed venous thromboembolism who receive initial treatment with therapeutic dosages of UFH (unfractionated heparin), LMWH (low molecular weight heparin) 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

Criterios de exclusión

Active bleeding or bleeding risk contraindicating anticoagulant therapy
An estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\*2 (in children younger than 1 year, serum creatinine results above 97.5th percentile excludes participation)
Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or ALT\> 5x upper level of normal (ULN) or total bilirubin \> 2x ULN with direct bilirubin \> 20% of the total
Platelet count \< 50 x 109/L
Sustained uncontrolled hypertension defined as \> 95th age percentile
Life expectancy \< 3 months
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
Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
Childbearing potential without proper contraceptive measures, pregnancy or breast feeding

Intervenciones

drug

Rivaroxaban (Xarelto, BAY59-7939)

Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily or twice daily, as tablets

drug

Rivaroxaban (Xarelto, BAY59-7939)

Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily, twice daily or three times daily, as oral suspension

drug

Standard of Care

LMWH (low molecular weight heparin) or fondaparinux or vitamin K antagonist (VKA) therapy. dose : as per standard of care

Ubicaciones

San Miguel de Tucumán, Tucumán Province, Argentina

Patrocinadores

PrincipalBayer

ColaboradorJanssen Research & Development, LLC

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