Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
With
Janssen Research & Development, LLC
Age
0–12
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
* Gestational age at birth of at least 37 weeks
* Oral feeding/ nasogastric/ gastric feeding for at least 10 days
Normal PT and aPTT within 10 days prior to planned study drug administration
Written informed consent provided and, if applicable, child assent provided
You may not be if
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:
* coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase (ALT) \> 5x upper level of normal (ULN), or
* total bilirubin \> 2x ULN with direct bilirubin \> 20% of the total.
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
Clareo Health | Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in Children
