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Completed

NCT Number: NCT01145859

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

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.

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Key information

Conditions

Venous Thrombosis Cardiovascular Diseases Embolism and Thrombosis Pediatrics Thrombosis Vascular Diseases

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

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

Primary outcomes

  1. Pharmacokinetics parameters (AUC and Cmax)

    Time frame: From Day 1 to Day 2

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

    Time frame: From Day 1 to Day 2

Secondary outcomes

  1. Safety and tolerability of rivaroxaban in pediatric subjects

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jun 17, 2010
Registry last updated
Aug 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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