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

This study is currently recruiting participants.
Verified April 2014 by Bayer
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01145859
First received: June 16, 2010
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Venous Thrombosis
Pediatrics
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Pharmacokinetics parameters (AUC and Cmax) [ Time Frame: From Day 1 to Day 2 ] [ Designated as safety issue: No ]
  • Pharmacodynamics parameters (PT, aPTT and anti-factor Xa) [ Time Frame: From Day 1 to Day 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of rivaroxaban in pediatric subjects [ Time Frame: Day 1, day 2 plus 7 days follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: November 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Rivaroxaban (Xarelto, BAY59-7939)
Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145859

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Show 35 Study Locations
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01145859     History of Changes
Other Study ID Numbers: 12892, 2009-017313-30
Study First Received: June 16, 2010
Last Updated: April 7, 2014
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Ethikkommission
Austria: Federal Office for Safety in Health Care
Canada: Ethics Review Committee
Canada: Health Canada
Israel: Ethics Commission
Israel: Ministry of Health
Italy: Ethics Committee
Italy: National Institute of Health
United States: Food and Drug Administration
United States: Institutional Review Board
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ireland: Irish Medicines Board
Switzerland: Swissmedic

Keywords provided by Bayer:
Venous Thrombosis
Pediatrics

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism

ClinicalTrials.gov processed this record on April 21, 2014