Single-dose Study Testing Rivaroxaban Granules for Oral Suspension Formulation in Children From 2 Months to 12 Years With Previous Thrombosis
Single-dose Study Testing Rivaroxaban Granules for Oral Suspension Formulation in Children From 2 Months to 12 Years With Previous Thrombosis
To characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability
Inclusion Criteria:
Children with an age ≥2 months and weight between 3 and <12 kg, who have completed anticoagulant treatment at least 10 days prior to the planned study drug administration.
Normal PT and aPTT within 10 days prior to planned study drug administration
Written informed consent provided and, if applicable, child assent provided
Exclusion Criteria:
Active bleeding or high risk for bleeding, contraindicating anticoagulant therapy
Planned invasive procedures, including removal of central lines, within 24 hours before and after single dose intake
An estimate glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
Hepatic disease which is associated either with:
Platelet count < 50 x 10^9/L
Hypertension (defined as systolic and/or diastolic blood pressure >95th percentile for age)
Concomitant use of strong inhibitors of both CYP3A4 and P-glycoprotein, e.g., all human immunodeficiency virus protease inhibitors and the following azoleantimycotic agents: ketoconazole, itraconazole, voriconazole, and posaconazole, if used systemically (fluconazole is allowed)
Concomitant use of strong inducers of CYP3A4, e.g., rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
Inability to cooperate with the study procedures
Hypersensitivity to rivaroxaban
Participation in a study with an investigational drug other than rivaroxaban or a medical device within 30 days prior to treatment
History of gastrointestinal disease or surgery associated with impaired absorption
HUS, 00029, Finland