Single-dose pilot study of oral rivaroxaban in pediatric subjects with venous thromboembolism
- Conditions
- Venous thromboembolism.
- Registration Number
- EUCTR2009-017313-30-AT
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 48
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
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
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to investigate pharmacokinetics and pharmacodynamics of single oral doses of rivaroxaban in paediatric subjects in order to obtain weight adjusted doses with equivalent exposure compared to 10 mg and 20 mg doses in adults.;Secondary Objective: The secondary objective of this study is to assess safety and tolerability of rivaroxaban in paediatric subjects.;Primary end point(s): None
- Secondary Outcome Measures
Name Time Method