Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects

Bayer59 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Venous Thrombosis Pediatrics

Interventions

Rivaroxaban (Xarelto, BAY59-7939)DRUG

Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (36)

Unnamed facility

Outcomes

Primary Outcomes

Pharmacokinetics parameters (AUC and Cmax)

Time frame: From Day 1 to Day 2

Pharmacodynamics parameters (PT, aPTT and anti-factor Xa)

Time frame: From Day 1 to Day 2

Secondary Outcomes

Safety and tolerability of rivaroxaban in pediatric subjects

Time frame: Day 1, day 2 plus 7 days follow up

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.