Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects
Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism
2 other identifiers
interventional
59
9 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2010
Longer than P75 for phase_1
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2010
CompletedFirst Posted
Study publicly available on registry
June 17, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedAugust 6, 2015
August 1, 2015
4.7 years
June 16, 2010
August 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Safety and tolerability of rivaroxaban in pediatric subjects
Day 1, day 2 plus 7 days follow up
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Janssen Research & Development, LLCcollaborator
Study Sites (36)
Unknown Facility
Little Rock, Arkansas, 72202-3500, United States
Unknown Facility
Los Angeles, California, 90027-6089, United States
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
Orange, California, 92868, United States
Unknown Facility
Gainesville, Florida, 32610, United States
Unknown Facility
St. Petersburg, Florida, 33701, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Detroit, Michigan, 48201-2196, United States
Unknown Facility
New Hyde Park, New York, 11040, United States
Unknown Facility
Chapel Hill, North Carolina, 27514, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Cleveland, Ohio, 44106-6007, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15224, United States
Unknown Facility
Brisbane, Queensland, 4029, Australia
Unknown Facility
Parkville, Victoria, 3052, Australia
Unknown Facility
Vienna, Vienna, 1090, Austria
Unknown Facility
Linz, 4020, Austria
Unknown Facility
Edmonton, Alberta, T6G 1C9, Canada
Unknown Facility
Hamilton, Ontario, L8N 3Z5, Canada
Unknown Facility
Toronto, Ontario, M5G 1X8, Canada
Unknown Facility
Clermont-Ferrand, 63003, France
Unknown Facility
Montpellier, 34059, France
Unknown Facility
Paris, 75015, France
Unknown Facility
Toulouse, 31059, France
Unknown Facility
Lübeck, Schleswig-Holstein, 23538, Germany
Unknown Facility
Crumlin, Dublin, 12, Ireland
Unknown Facility
Jerusalem, 9112001, Israel
Unknown Facility
Tel Litwinsky, 5262000, Israel
Unknown Facility
Genova, 16147, Italy
Unknown Facility
Milan, 20122, Italy
Unknown Facility
Pavia, 27100, Italy
Unknown Facility
Torino, 10126, Italy
Unknown Facility
Basel, Canton of Basel-City, 4056, Switzerland
Related Publications (3)
Willmann S, Thelen K, Kubitza D, Lensing AWA, Frede M, Coboeken K, Stampfuss J, Burghaus R, Muck W, Lippert J. Pharmacokinetics of rivaroxaban in children using physiologically based and population pharmacokinetic modelling: an EINSTEIN-Jr phase I study. Thromb J. 2018 Dec 4;16:32. doi: 10.1186/s12959-018-0185-1. eCollection 2018.
PMID: 30534008DERIVEDKubitza D, Willmann S, Becka M, Thelen K, Young G, Brandao LR, Monagle P, Male C, Chan A, Kennet G, Martinelli I, Saracco P, Lensing AWA. Exploratory evaluation of pharmacodynamics, pharmacokinetics and safety of rivaroxaban in children and adolescents: an EINSTEIN-Jr phase I study. Thromb J. 2018 Dec 4;16:31. doi: 10.1186/s12959-018-0186-0. eCollection 2018.
PMID: 30534007DERIVEDWillmann S, Becker C, Burghaus R, Coboeken K, Edginton A, Lippert J, Siegmund HU, Thelen K, Muck W. Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban. Clin Pharmacokinet. 2014 Jan;53(1):89-102. doi: 10.1007/s40262-013-0090-5.
PMID: 23912563DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2010
First Posted
June 17, 2010
Study Start
November 1, 2010
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
August 6, 2015
Record last verified: 2015-08