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

August 5, 2015 updated by: Bayer

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4029
    • Victoria
      • Parkville, Victoria, Australia, 3052
  • Austria
      • Linz, Austria, 4020
      • Wien, Austria, 1090
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1C9
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
      • Toronto, Ontario, Canada, M5G 1X8
  • France
      • CLERMONT-FERRAND Cedex 1, France, 63003
      • Montpellier, France, 34059
      • Paris, France, 75015
      • TOULOUSE Cedex 9, France, 31059
  • Germany
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
  • Ireland
    • Dublin
      • Crumlin, Dublin, Ireland, 12
  • Israel
      • Jerusalem, Israel, 9112001
      • Tel Hashomer, Israel, 5262000
  • Italy
      • Genova, Italy, 16147
      • Milano, Italy, 20122
      • Pavia, Italy, 27100
      • Torino, Italy, 10126
  • Switzerland
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4056
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202-3500
    • California
      • Los Angeles, California, United States, 90095
      • Los Angeles, California, United States, 90027-6089
      • Orange, California, United States, 92868
    • Florida
      • Gainesville, Florida, United States, 32610
      • St. Petersburg, Florida, United States, 33701
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Indiana
      • Indianapolis, Indiana, United States, 46260
      • Indianapolis, Indiana, United States, 46202
    • Michigan
      • Detroit, Michigan, United States, 48201-2196
    • New York
      • New Hyde Park, New York, United States, 11040
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Cleveland, Ohio, United States, 44106-6007
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics parameters (AUC and Cmax)
Time Frame: From Day 1 to Day 2
From Day 1 to Day 2
Pharmacodynamics parameters (PT, aPTT and anti-factor Xa)
Time Frame: From Day 1 to Day 2
From Day 1 to Day 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of rivaroxaban in pediatric subjects
Time Frame: Day 1, day 2 plus 7 days follow up
Day 1, day 2 plus 7 days follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

June 16, 2010

First Submitted That Met QC Criteria

June 16, 2010

First Posted (Estimate)

June 17, 2010

Study Record Updates

Last Update Posted (Estimate)

August 6, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12892
  • 2009-017313-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe