- Assess the incidence of major bleeding and clinically relevant non-major bleeding- Assess the incidence of recurrent venous thromboembolism- Assess the asymptomatic deterioration in the thrombotic burden on repeat imaging- Characterize the…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assess the incidence of major bleeding and clinically relevant non-major
bleeding
Secondary outcome
- Assess the incidence of recurrent venous thromboembolism
- Assess the asymptomatic deterioration in the thrombotic burden on repeat
imaging
- Characterize the pharmacokinetic/harmacodynapic profily of a 30-day treatment
with oral rivaroxaban
Background summary
Treatment with heparins and VKA (vitamin K antagonist) has several unsatisfying
aspects. For heparins, this includes the requirement for intravenous or
subcutaneous injection and monitoring of the activated partial thromboplastin
time (aPTT) and assessment of anti Xa. For VKA, this includes frequent INR
(international normalized ratio) monitoring. An oral anticoagulant drug that
requires no monitoring of its effect, with a rapid onset of action and a high
benefit-risk ratio is of considerable interest for the pediatric population.
Study objective
- Assess the incidence of major bleeding and clinically relevant non-major
bleeding
- Assess the incidence of recurrent venous thromboembolism
- Assess the asymptomatic deterioration in the thrombotic burden on repeat
imaging
- Characterize the pharmacokinetic/pharmacodynamic profile of a 30-day
treatment with oral rivaroxaban
Study design
This is a single arm study evaluating the safety, efficacy and PK/PD profile of
a 30 day treatment with age- and body weight-adjusted oral rivaroxaban in
children aged 6 months < 6 years with various manifestations of symptomatic or
asymptomatic venous thrombosis.
Intervention
1. rivaroxaban (suspension), twice daily for 30 days
Study burden and risks
The study includes 5 planned visits. 4 blood samples will be taken and the
total blood volume taken will be 12 ml. The child will receive a diary to
collect information regarding drug intake at the day before each visit and at
visit. Children older than 4 years
will complete a Taste and Texture questionnaire about oral suspension during
one of the visits.General physical exam will be performed during each visit.
There is a chance for (unknown) side effect, as is documented ion the SmPC of
rivaroxaban.
Energieweg 1
Mijdrecht 3641 RT
NL
Energieweg 1
Mijdrecht 3641 RT
NL
Listed location countries
Age
Inclusion criteria
1. Children aged between 6 months to < 6 years who have been treated for at least 2 months or, in case of catheter related thrombosis, for at least 6 weeks with LMWH, fondaparinux and/or VKA for documented symptomatic or asymptomatic venous thrombosis ;2. Hemoglobin, platelets, creatinine, alanine aminotransferase (ALT) and bilirubin evaluated within 10 days prior to randomization;3. Informed consent provided
Exclusion criteria
1. Active bleeding or high risk for bleeding contraindicating anticoagulant therapy;2. Symptomatic progression of venous thrombosis during preceding anticoagulant treatment;3. Planned invasive procedures, including lumbar puncture and removal of non-peripherally placed central lines during study treatment;4. An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2;5. 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;6. Platelet count < 50 x 109/L;7. Hypertension defined as > 95th age percentile ;8. Life expectancy < 3 months;9. 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;10. Concomitant use of strong inducers of CYP3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine;11. Hypersensitivity or any other contraindication listed in the local labeling for the comparator treatment or experimental treatment;12. Inability to cooperate with the study procedures;13. Previous randomization to this study;14. Participation in a study with an investigational drug or medical device within 30 days prior to randomization.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-000566-22-NL |
| ClinicalTrials.gov | NCT02309411 |
| CCMO | NL48610.078.14 |