Rivaroxaban for treatment in venous thrombosis in childre
- Conditions
- Venous ThrombosisTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-000565-47-IT
- Lead Sponsor
- Bayer HealthCare 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 high risk for bleeding 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. Hypertension defined as > 95th age percentile a
6. Life expectancy < 3 months
7. 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
8. Concomitant use of strong inducers of CYP3A4, i.e. 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. 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 Main Objective: The primary efficacy objective is: To assess the incidence of symptomatic recurrent venous thromboembolism<br><br>The principal safety objective is: ? To assess the incidence of overt major and clinically relevant non-major bleeding.;Secondary Objective: The secondary efficacy objective is: To assess the incidence of symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging.<br>An additional objective is: To characterize the pharmacokinetic / pharmacodynamics profile of rivaroxaban.;Primary end point(s): 1. Efficacy: The composite of all symptomatic recurrent venous thromboembolism<br><br>2. Safety: The composite of overt major and clinically relevant non-major bleeding.;Timepoint(s) of evaluation of this end point: 1. After 90 days of treatment and again at 30 days post treatment<br><br>2. After 90 days of treatment and again at 30 days post treatment<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. The composite of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging.<br><br>2. Results of pharmacokinetics (PK)/ pharmacodynamics (PD) analyses;Timepoint(s) of evaluation of this end point: 1. After 90 days of treatment and again at 30 days post treatment<br><br>2. PK and PD as defined in the protocol