Single-dose pilot study of oral rivaroxaban in pediatric subjects with venous thromboembolism - ND

• Conditions: Venous thromboembolism.; MedDRA version: 9.1Level: LLTClassification code 10049909

• Registration Number: EUCTR2009-017313-30-IT
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-12
• Last Update Posted: 18 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Subjects must fulfill all of the following criteria before being included in the treatment period: • Pediatric subjects =6 months and <18 years of age at the time of administration of study drug who have completed treatment of VTE, but are considered to have a risk for recurrence • Pediatric subjects who can take oral medication • Written informed consent (and age appropriate assent) as per local requirements • Clinically stable pediatric subjects who can be treated on an ambulatory basis.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects are to be excluded from the study if they display any of the following criteria: • Any condition requiring ongoing anticoagulation • Known bleeding disorder • Any major or clinically relevant bleed during the previous VTE treatment • Abnormal coagulation test results within 7 days prior to study drug administration (Visit 2) • Planned invasive procedures (including removal of central lines) 24 hours before and after single dose • Participation in a therapeutic study with a new investigational drug within 30 days prior to study drug administration (Visit 2) • Severe renal impairment, eg calculated creatinine clearance <30 mL/min for children > 12 years (for Cockcroft-Gault see Section 14.6) (13) • AST, ALT, and GGT >3 x upper limit of normal (ULN), bilirubin >2 x ULN, any active hepatitis, any history of hepatitis B or C • Known bacterial endocarditis • Life expectancy <3 months • Platelet count <150 x 109/L • Hypertension (as defined by >95th percentile for age) (see Section 14.7) (14) • Concomitant use of strong CYP3A4 inhibitors such as HIV protease inhibitors (indinavir, nelfinavir, ritonavir, atazanavir, lopinavir, amprenavir, saquinavir, delavirdine, tipranavir, darunavir, saquinavir), macrolid/ketolid, antibiotics (clarithromycin, erythromycin, telithromycin, troleandomycin), antimycotic agents [itraconazole, posaconazole, variconazole, ketoconazole (topical formulations are allowed)], the antidepressant nefazodone • Pregnancy or lactation in menstruating girls • Previous assignment to treatment during this study • Close affiliation with the investigational site, eg a close relative of the investigator, dependent person (eg employee or student of the investigational site) • Medical disorder, condition, or history of such that would impair the subject`s ability to participate or complete this study in the opinion of the investigator or the sponsor • History of gastrointestinal disease (eg Crohn`s disease) which could result in impaired absorption of the study drug • Any other disease or condition which may influence the physiological metabolic turnover (eg endocrine diseases, febrile condition, severe infections) • Febrile illness within 7 days prior to study drug administration (Visit 2) • History of severe allergies, non-allergic drug reactions, or multiple drug allergies • Hypersensitivity to the investigational drug and/or to inactive constituents • Concomitant use of drugs that influence the coagulation system, eg antiplatelet drugs (such as acetylsalicylic acid, ticlopidine, and clopidogrel, abciximab, tirofiban, and integrelin) or other anticoagulants (anti-thrombins, unfractionated heparin, low molecular weight heparin, hirudin, coumarin-type anticoagulants such as phenprocoumon and warfarin) within 10 days prior to study drug administration (Visit 2) • Concomitant use of strong cytochrome P450 3A4 inducers, eg rifampicin, rifabutin dexamethasone, phenobarbital, primidone, phenytoin, carbamazepine, St. John`s wort (Hypericum perforatum) within 14 days prior to study drug administration (Visit 2) • Change in subject`s chronic medication within 14 days prior to study drug administration (Visit 2)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified