Clinical trial NCT01145859: Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects
Official title: Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Venous Thrombosis
Pediatrics
Keywords: Venous Thrombosis
Pediatrics
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2010-06-17
Enrollment: 59
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility 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

Primary outcomes:
measure: Pharmacokinetics parameters (AUC and Cmax)
timeFrame: From Day 1 to Day 2
measure: Pharmacodynamics parameters (PT, aPTT and anti-factor Xa)
timeFrame: From Day 1 to Day 2
Secondary outcomes:
measure: Safety and tolerability of rivaroxaban in pediatric subjects
timeFrame: Day 1, day 2 plus 7 days follow up
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Detroit
country: United States
state: Michigan
city: New Hyde Park
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Brisbane
country: Australia
state: Queensland
city: Parkville
country: Australia
state: Victoria
city: Linz
country: Austria
city: Wien
country: Austria
city: Edmonton
country: Canada
state: Alberta
city: Hamilton
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: CLERMONT-FERRAND Cedex 1
country: France
city: Montpellier
country: France
city: Paris
country: France
city: TOULOUSE Cedex 9
country: France
city: Lübeck
country: Germany
state: Schleswig-Holstein
city: Crumlin
country: Ireland
state: Dublin
city: Jerusalem
country: Israel
city: Tel Hashomer
country: Israel
city: Genova
country: Italy
city: Milano
country: Italy
city: Pavia
country: Italy
city: Torino
country: Italy
city: Basel
country: Switzerland
state: Basel-Stadt
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Kubitza 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.
citation: Willmann 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.