Trial Condition(s):
Oral Rivaroxaban in Children with Venous Thrombosis (EINSTEINJunior)
14373
Not Available
The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. There will also be a check for bleeding and worsening of blood clots.
- Children aged 6 to < 18 years with documented symptomatic or asymptomatic venous thrombosis treated for at least 2 months or, in case of catheter related thrombosis, treated for at least 6 weeks with LMWH (low molecular weight heparin), , fondaparinux and/or VKA (vitamin K antagonist). - Informed consent provided and, if applicable, child assent provided
- Active bleeding or high risk for bleeding contraindicating anticoagulant therapy - Symptomatic progression of venous thrombosis during preceding anticoagulant treatment - Planned invasive procedures, including lumbar puncture and removal of non peripherally placed central lines during study treatment - An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 - Hepatic disease which is associated with 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 10^9/L - 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), i.e. 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, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
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Locations Investigative Site Lübeck, Germany, 23538 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Los Angeles, United States, 90027-6089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75019 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site TOULOUSE Cedex 9, France, 31059 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16147 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Bari, Italy, 70124 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site UTRECHT, Netherlands, 3584 CX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NIJMEGEN, Netherlands, 6525 GA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AMSTERDAM, Netherlands, 1081 HV | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ROTTERDAM, Netherlands, 3015 GJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ramat Gan, Israel, 5262000 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Westmead, Australia, 2145 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site PARIS, France, 75015 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Erlangen, Germany, 91054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Detroit, United States, 48201-2196 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Edmonton, Canada, T6G 2B7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Little Rock, United States, 72202-3500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Hyde Park, United States, 11040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linz, Austria, 4020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3109601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Freiburg, Germany, 79106 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
30-day, single-arm study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in children with various manifestations of venous thrombosis
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
5