Rivaroxaban for treatment in venous thrombosis in childre
- Conditions
- Venous ThrombosisTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-000565-47-PL
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
1. Children aged 6 months 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.
2. Informed consent provided and, if applicable, child assent provided
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 either: with 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
follwoing 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. Previous assignment to treatment during this study.
13. Participation in a study with an investigational drug or medical device within 30 days prior to randomization
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method