CTRI/2019/04/018361招募中3 期
An Open-Label, Randomised, Parallel group, Multicentre, Observational Trial To Evaluate Safety And Efficacy Of Edoxaban Tosylate In Children From 38 Weeks Gestational Age To Less Than 18 Years Of Age With Cardiac Diseases At Risk Of Thromboembolic Events - NA
试验速览
- 阶段
- 3 期
- 状态
- 招募中
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 eligible for the study:
- •1.Children with cardiac diseases who are at risk for thromboembolic complications and require at least 3 months antithrombotic anticoagulant prophylaxis.
- •Either one of the following:
- •a. Children with cardiac disease who have a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).
- •b. Children with cardiac disease who require (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.
- •Cardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis.1 Some examples of cardiac conditions at risk of
- •thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock- Taussig and Glenn surgery.
- •2. Male or female children between 1 and <18 years of age. Children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of
- •age in the edoxaban arm have been evaluated at the end of the 3-month treatment period.
- •3. 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 be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.
- •4. Female subjects of childbearing potential must test negative for pregnancy at Screening and must consent to avoid becoming pregnant by using a locally approved contraception method throughout the study.
排除标准
- •Subjects with evidence of the following up to randomization:
- •-Symptomatic venous or arterial TE
- •-Asymptomatic venous or arterial TE found by routine imaging
- •-Asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period.
- •Note: Valid echocardiograms are defined here as images taken within 5 weeks prior to Randomization Visit.
- •2. Subjects with mechanical heart valves.
- •3. Subjects with active bleeding or high risk of bleeding contraindicating treatment with anticoagulant.
- •4. Subjects with a contraindication to the use of heparin (UFH or LMWH) and/or VKA (see Appendix 17.4).
- •5. Co-administration of antithrombotic therapy is contraindicated in edoxaban arm and SOC arm except for low dose aspirin defined as 1 to 5 mg/kg/day with maximum of 100 mg/day (see Appendix 17.5).
- •6. Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded (see Appendix 17.5.6).
- •7. 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 (TBL) >2 Ã? ULN with direct bilirubin >20% of the total at Screening.
- •8. Subjects with estimated glomerular filtration rate (eGFR) <30% of normal for age and size (see Appendix 17.9).
- •9. Subjects with stage 2 hypertension defined as blood pressure (BP) systolic and/or diastolic confirmed >99th percentile plus 5 mmHg (see Appendix 17.10).
- •10. Subjects with thrombocytopenia (thrombocytes <50 Ã? 109/L).
- •11. Subjects with Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy.
- •12. Subjects with a life expectancy less than the expected study duration (3 months).
- •13. Subjects who are known to be pregnant or breastfeeding.
- •14. Subjects who are not using an approved method of contraception (
- •15. 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
- •16. Subject who participated in another clinical study or treated with an experimental therapy with less than a 30-day washout period prior to the Screening Visit.
研究者
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