-Assess the incidence of major bleeding and clinically relevant non-major bleeding -Assess the incidence of recurrent venous thromboembolism -Characterize the pharmacokinetic/ pharmacodynamic profile of a 30-day treatment with oral rivaroxaban
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Composite of major and clinically relevant non-major bleeding
Secondary outcome
Composite of all recurrent venous thromboembolism; results of pharmacokinetics
(PK) / pharmacodynamics (PD).
Background summary
Rivaroxaban is registered in The Netherlands for the treatment of DVT and the
prevention of recurrent DVT and pulmonary embolism (PE) after an acute DVT in
adults. In this study, rivaroxaban will be evaluated in children with venous
thrombosis, in order to be able to make a choice in the future for children
between the (new) anticoagulantia.
See also protocol pages 15-19.
Study objective
-Assess the incidence of major bleeding and clinically relevant non-major
bleeding
-Assess the incidence of recurrent venous thromboembolism
-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 between 6 and < 18 years with various manifestations of
symptomatic and asymptomatic venous thrombosis.
Intervention
Randomization into 1 group:
1.rivaroxaban (tablets [once daily] or suspension [twice daily]), for 30 days
Study burden and risks
For this study, the patient will visit the hospital 5x, which is for some
patients more often than normal (depending on the standard treatment which
differs slightly per site). A total of 4 PK/PD blood samples will be taken
during visit 3 and 4, which will normally not be taken. This is the minimum
amount of blood needed for adequate analysis. However, these patients will
require no INR-monitoring or daily heparin injections. A "taste and texture"
questionnaire (for children below 12 years of oral rivaroxaban suspension) and
a simple study booklet need to be completed. There is a chance for (unknown)
side effects, as is documented in the SmPC of rivaroxaban.
In this study, rivaroxaban will be administered after at least 2 months of
treatment with standard of care anticoagulant, when the risk of recurrence of
thrombotic complications and bleeding is expected to diminish compared to the
first months of anticoagulant treatment. In adults, rivaroxaban is administered
orally and is characterized by stable and predictable pharmacokinetics and,
therefore, does not require laboratory monitoring with subsequent dose
adjustments. Furthermore, selected rivaroxaban dose regimen was extensively
tested in large phase III studies in adults in which it had a similar efficacy
and safety profile as standard of care anticoagulant.
Energieweg 1
Mijdrecht 3641 RT
NL
Energieweg 1
Mijdrecht 3641 RT
NL
Listed location countries
Age
Inclusion criteria
1. Children aged 6 years to < 18 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 and alanine aminotransferase (ALT) evaluated within 10 days prior to visit 2;3. Informed consent provided and, if applicable, child assent 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 coagulopathy leading to a clinically relevant bleeding risk;6. Platelet count < 50 x 10^9/L;7. Hypertension defined as > 95th age percentile ;8. Concomitant use of strong inhibitors of both CYP3A4 and P-gp, i.e. all human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically (fluconazole is allowed);9. Concomitant use of strong inducers of CYP3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
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 | EUCTR2011-004539-30-NL |
| ClinicalTrials.gov | NCT01684423 |
| CCMO | NL41912.018.12 |