Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE) (NCT02798471) | Clinical Trial Compass
CompletedPhase 3
Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
United States290 participantsStarted 2017-03-27
Plain-language summary
This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to compare the efficacy and safety of edoxaban against standard of care in pediatric subjects with confirmed VTE.
Who can participate
Age range1 Day ā 17 Years
SexALL
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Inclusion criteria
ā. 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.
ā. Pediatric subjects with the presence of documented VTE confirmed by appropriate diagnostic imaging and requiring anticoagulant therapy for at least 90 days.
ā. Subjects must have received at least 5 days of heparin 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 international normalized ratio (INR) \< 2.0.
ā. Subject and/or parent(s)/legal guardian(s) or legally acceptable representative is informed and provides signed consent for the child to participate in the study.
ā. Female subjects who have menarche must test negative for pregnancy at Screening and must consent to avoid becoming pregnant by using an approved contraception method throughout the study.
Exclusion criteria
ā. 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).
ā. Subjects who have been or are being treated with thrombolytic agents, thrombectomy or insertion of a caval filter for the newly identified index VTE.
ā. 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.
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What they're measuring
1
Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Timeframe: Randomization to Month 3
2
Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Timeframe: Randomization to Month 3
3
Number of Participants With No Change or Extension of Thrombotic Burden During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
. Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded.
ā. 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 Ć the upper limit of normal (ULN) or total bilirubin \> 2 Ć ULN with direct bilirubin \> 20% of the total at Screening Visit.
ā. Subjects with glomerular filtration rate (GFR) \< 30% of normal for age and size as determined by the Schwartz formula.
ā. Subjects with stage 2 hypertension defined as blood pressure (BP) systolic and/or diastolic confirmed \> 99th percentile + 5 mmHg.
ā. Subject with thrombocytopenia \< 50 Ć 109/L at Screening Visit. Subjects with a history of heparin-induced thrombocytopenia may be enrolled in the study at the Investigator's discretion.