Phase 2
Completed N=63
Oral Rivaroxaban in Children With Venous Thrombosis
Source: ClinicalTrials.gov NCT01684423 ↗Enrolled (actual)
63
Serious AEs
4.8%
Results posted
Sep 2017
Primary outcomePrimary: Number of Subjects With Major 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. There will also be a check for bleeding and worsening of blood clots.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events |
0; 0; 0; 0; 0; 3 | — |
| SECONDARY Number of Subjects With Symptomatic Recurrent Venous Thromboembolism |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden |
3; 2; 2; 4; 1; 4 | — |
| SECONDARY Change From Baseline in Prothrombin Time at Specified Time Points |
8.964; 9.083; 3.147; 4.218; 2.817; 1.984 | — |
| SECONDARY Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points |
10.982; 12.818; 2.995; 6.136; 5.900; 1.858 | — |
| SECONDARY Anti-factor Xa Values at Specified Time Points |
16.081; 8.136; 31.553; 185.481; 252.853; 99.415 | — |
| SECONDARY Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points |
20.4822; 7.4367; 41.6025; 219.6933; 240.6319; 119.2201 | — |
Eligibility Criteria
Inclusion Criteria
- Children aged 6 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
Data sourced from ClinicalTrials.gov (NCT01684423). 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.