Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-25 @ 4:35 AM
NCT ID:
NCT02564718
Eligibility Criteria:
Inclusion Criteria:
* Children from birth to less than 6 months with documented symptomatic or asymptomatic venous or arterial thrombosis who have been treated with anticoagulant therapy for at least 5 days.
* Gestational age at birth of at least 37 weeks.
* Hemoglobin, platelets, creatinine, ALT and total and direct bilirubin assessed within 10 days prior to enrollment.
* Oral feeding/nasogastric/gastric feeding for at least 10 days.
* Informed consent provided.
* Body weight \>2600 g
Exclusion Criteria:
* Active bleeding or high risk for bleeding contraindicating anticoagulant therapy, including history of intra-ventricular bleeding.
* Symptomatic progression of thrombosis during preceding anticoagulant treatment.
* Planned invasive procedures, including lumbar puncture and removal of non-peripherally placed central lines during study treatment.
* Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase (ALT) \> 5x upper level of normal (ULN) or total bilirubin (TB) \> 2x ULN with direct bilirubin \> 20% of the total.
* Creatinine \>1.5 times of normal.
* Uncontrolled Hypertension defined as \>95th percentile.
* History of gastrointestinal disease or surgery associated with impaired absorption.
* Platelet count \<100 x 109/L.
* Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), e.g. all human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically (fluconazole is allowed)
* Concomitant use of strong inducers of CYP3A4, e.g. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
* Indication for anticoagulant therapy other than current thrombosis.
* Indication for antiplatelet therapy or non-steroid anti-inflammatory drug (NSAID) therapy. Incidental use is allowed.
* Hypersensitivity to rivaroxaban or its excipients.
* Participation in a study with an investigational drug or medical device within 30 days prior to enrollment.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
6 Months
Study:
NCT02564718
Study Brief:
Protocol Section:
NCT02564718