A Phase 3, Open-Label, Randomized, Multicenter, Controlled Trial To Evaluate The Pharmacokinetics And Pharmacodynamics Of Edoxaban And To Compare The Efficacy And Safety Of Edoxaban With Standard Of Care Anticoagulant Therapy In Pediatric Subjects From Birth To Less Than 18 Years Of Age With Confirmed Venous Thromboembolism (VTE)

Daiichi Sankyo Inc0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 3 期
状态: 招募中
发起方: Daiichi Sankyo Inc

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•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 < 2.0.
•4. 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 with edoxaban treatment. Pediatric subjects with appropriate intellectual maturity will berequired to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.
•5. 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

排除标准

•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. 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 Ã? the upper limit of normal (ULN) or total bilirubin > 2 Ã? ULN with direct bilirubin > 20% of the total at Screening Visit.
•5. Subjects with glomerular filtration rate (GFR) < 30% of normal for age and size. as determined by the Schwartz formula.
•6. Subjects with stage 2 hypertension defined as blood pressure (BP) systolic and/or diastolic confirmed > 99th percentile + 5 mmHg
•7. Subject with thrombocytopenia < 50 Ã? 109/L at Screening Visit. Subjects with a history of heparin induced thrombocytopenia may be enrolled in the study at the Investigatorâ??s discretion.
•8. Life expectancy less than the expected study treatment duration (3 months).
•9. Subjects who are known to be pregnant or breastfeeding.
•10. 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.

研究者

发起方

Daiichi Sankyo Inc

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