Phase 2
Completed N=46
EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis
Source: ClinicalTrials.gov NCT02309411 ↗Enrolled (actual)
46
Serious AEs
6.5%
Results posted
Jun 2018
Primary outcomePrimary: Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events — 0; 0; 0; 0 Participants
Summary
The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events |
0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Symptomatic Recurrent Venous Thromboembolism |
0; 0 | — |
| SECONDARY Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging |
6; 4; 15; 4; 1; 3 | — |
| SECONDARY Change From Baseline in Prothrombin Time at Specified Time Points |
2.777; 2.514; 2.586; 4.764 | — |
| SECONDARY Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points |
6.455; -3.479; 2.814; 21 | — |
| SECONDARY Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points |
72.8494; 68.0072; 108.6053; 76.5371; 112.3578; 61.3817 | — |
Eligibility Criteria
Inclusion Criteria
- Children aged 6 months to 5x upper level of normal (ULN) or total bilirubin > 2x ULN with direct bilirubin > 20% of the total
- Platelet count 95th age percentile
- Life expectancy < 3 months
- 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
- Concomitant use of strong inducers of CYP3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
- Hypersensitivity or any other contraindication listed in the local labeling for the comparator treatment or experimental treatment
- Inability to cooperate with the study procedures
- Previous randomization to this study
- Participation in a study with an investigational drug or medical device within 30 days prior to randomization
Data sourced from ClinicalTrials.gov (NCT02309411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.