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

Phase 1

Completed

• Conditions: Pediatrics; Venous Thrombosis
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939)

• Registration Number: NCT01145859
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Study Start: 2010-11
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-05
• Last Update Posted: 2015-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Rivaroxaban (Xarelto, BAY59-7939)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Safety and tolerability of rivaroxaban in pediatric subjects	Day 1, day 2 plus 7 days follow up