Rivaroxaban for treatment in venous thrombosis in childre
- Conditions
- Venous ThrombosisMedDRA version: 20.0Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-000565-47-DE
- 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 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.
2. Informed consent provided and, if applicable, child assent provided
3. 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 170
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 (in children younger than 1 year, serum creatinine results above 97.5th percentile excludes participation)
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 following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically (fluconazole is allowed). For exceptions, see section 4.4 of the Clinical 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 highly effective (failure rate <1%) 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 treament 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