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

• ClinicalTrials.gov Identifier: NCT01145859
• Recruitment Status: Completed
• First Posted: June 17, 2010
• Last Update Posted: August 6, 2015
• Sponsor: Bayer
• Collaborator: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Venous Thrombosis; Pediatrics	Drug: Rivaroxaban (Xarelto, BAY59-7939)	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 59 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism
• Study Start Date: November 2010
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: July 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Arkansas

Little Rock, Arkansas, United States, 72202-3500

United States, California

Los Angeles, California, United States, 90027-6089

Los Angeles, California, United States, 90095

Orange, California, United States, 92868

United States, Florida

Gainesville, Florida, United States, 32610

St. Petersburg, Florida, United States, 33701

United States, Illinois

Chicago, Illinois, United States, 60611

United States, Indiana

Indianapolis, Indiana, United States, 46202

Indianapolis, Indiana, United States, 46260

United States, Michigan

Detroit, Michigan, United States, 48201-2196

United States, New York

New Hyde Park, New York, United States, 11040

United States, North Carolina

Chapel Hill, North Carolina, United States, 27514

Durham, North Carolina, United States, 27710

United States, Ohio

Cleveland, Ohio, United States, 44106-6007

United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Pittsburgh, Pennsylvania, United States, 15224

Australia, Queensland

Brisbane, Queensland, Australia, 4029

Australia, Victoria

Parkville, Victoria, Australia, 3052

Austria

Linz, Austria, 4020

Wien, Austria, 1090

Canada, Alberta

Edmonton, Alberta, Canada, T6G 1C9

Canada, 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

Lübeck, Schleswig-Holstein, Germany, 23538

Ireland

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, Basel-Stadt, Switzerland, 4056

Sponsors and Collaborators

Bayer

Janssen Research & Development, LLC

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Willmann S, Thelen K, Kubitza D, Lensing AWA, Frede M, Coboeken K, Stampfuss J, Burghaus R, Mück 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.

Kubitza D, Willmann S, Becka M, Thelen K, Young G, Brandão 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.

Willmann S, Becker C, Burghaus R, Coboeken K, Edginton A, Lippert J, Siegmund HU, Thelen K, Mück 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.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01145859
• Other Study ID Numbers: 12892; 2009-017313-30 ( EudraCT Number )
• First Posted: June 17, 2010
• Last Update Posted: August 6, 2015
• Last Verified: August 2015

Keywords provided by Bayer:

Venous Thrombosis; Pediatrics

Additional relevant MeSH terms:

Thrombosis; Venous Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Rivaroxaban; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anticoagulants