venous thromboembolism VTE
Conditions
Interventions
Edoxaban treatment will be dispensed to the subject on a monthly visit
schedule. The oldest cohort (12 to
Sponsors
Daiichi Sankyo, Inc.
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: Subjects must satisfy all of the following criteria to be included in the study: 1. Male or female pediatric subjects between birth (defined as 38 weeks gestational age) and less than 18 years of age at the time of consent. 2. Pediatric subjects with the presence of documented VTE confirmed by appropriate diagnostic imaging and requiring anticoagulant therapy for at least 90 days. 3. Subjects must have received at least 5 days of heparin (LMWH or SP Xa inhibitors or UFH according to the edoxaban label for VTE treatment) therapy prior to randomization to treat the newly identified index VTE. In addition, prior to being randomized to edoxaban or SOC, subjects initially treated with VKA are recommended to have an INR
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be disqualified from entering the study: 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 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) 99th percentile + 5 mmHg. 8. Subject with thrombocytopenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the composite endpoint consisting of incidence of symptomatic recurrent venous thromboembolic disease, death as result of VTE, and no change or extension of thrombotic burden (as defined in the protocol) during the first 3-months period. | — |
Secondary
| Measure | Time frame |
|---|---|
| A composite endpoint consisting of the incidence of symptomatic recurrent venous thromboembolic disease, death as a result of VTE, and no change or extension of thrombotic burden from randomization to the date of the last dose of study drug + 30 days. | — |
Countries
Netherlands
Outcome results
None listed