Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)

Exclusion Criteria

• •1. Subjects with active bleeding or high risk of bleeding contraindicating treatment with LMWH, SP Xa inhibitors, VKAs, or direct oral anticoagulants (DOACs; identified high risk of bleeding during prior experimental administration of DOACs).
• •2. Subjects who have been or are being treated with thrombolytic agents, thrombectomy or insertion of a caval filter for the newly identified index VTE.
• •3. Administration of antiplatelet therapy is contraindicated in both arms except for low dose aspirin defined as 1-5 mg/Kg/day with maximum of 100 mg/day.
• •4. Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded.
• •5. Subjects with hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk (aPTT \> 50 seconds or international normalized ratio \[INR\] \> 2.0 not related to anticoagulation therapy) or alanine aminotransferase (ALT) \> 5 × the upper limit of normal (ULN) or total bilirubin \> 2 × ULN with direct bilirubin \> 20% of the total at Screening Visit.
• •6. Subjects with glomerular filtration rate (GFR) \< 30% of normal for age and size as determined by the Schwartz formula.
• •7. Subjects with stage 2 hypertension defined as blood pressure (BP) systolic and/or diastolic confirmed \> 99th percentile + 5 mmHg.
• •8. Subject with thrombocytopenia \< 50 × 109/L at Screening Visit. Subjects with a history of heparin-induced thrombocytopenia may be enrolled in the study at the Investigator's discretion.
• •9. Life expectancy less than the expected study treatment duration (3 months).
• •10. Subjects who are known to be pregnant or breastfeeding.
• •11. Subjects with any condition that, as judged by the Investigator, would place the subject at increased risk of harm if he/she participated in the study, including contraindicated medications.
• •12. Subjects who participated in another clinical study or treated with an experimental therapy with less than a 30 day washout period prior to identifying the qualifying index VTE.