Pediatrics, Venous Thrombosis
Conditions
Keywords
Venous Thrombosis, Pediatrics
Brief summary
The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.
Interventions
DRUGRivaroxaban (Xarelto, BAY59-7939)
Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults
Sponsors
Janssen Research & Development, LLC
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric subjects \> 6 months and \< 18 years of age at the time of administration of study drug. * Patients who have completed treatment of VTE, but are considered to have risk for recurrence of VTE
Exclusion criteria
* Any major or clinically relevant bleeding during prior VTE treatment * Abnormal coagulation tests within 7 days prior to study drug administration * Severe renal impairment * Planned invasive procedures prior to or after 24 hours of study drug administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics parameters (AUC and Cmax) | From Day 1 to Day 2 |
| Pharmacodynamics parameters (PT, aPTT and anti-factor Xa) | From Day 1 to Day 2 |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of rivaroxaban in pediatric subjects | Day 1, day 2 plus 7 days follow up |
Countries
Australia, Austria, Canada, France, Germany, Ireland, Israel, Italy, Switzerland, United States
Outcome results
None listed