NL-OMON46927
已完成
3 期
A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure - Prevention of blood clots in children (2 to 8y) after Fontan procedure
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- single ventricle physiology
- 发起方
- Janssen-Cilag
- 入组人数
- 6
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Boys or girls 2 to 8 years of age with single ventricle physiology and who have completed the initial Fontan procedure within 4 months prior to enrollment
- •2\. Considered to be clinically stable by the investigator and able to tolerate oral or enteral administration of a suspension formulation and oral/enteral feedings
- •3\. Satisfactory initial post\-Fontan transthoracic echocardiographic screening as defined in the
- •Post\-Fontan Echocardiographic Examination Research Protocol
- •4\. Parent/legally acceptable representative must sign an informed consent form (ICF) and child assent will also be provided, if applicable, according to local requirements
排除标准
- •1\. Evidence of thrombosis, including those that are asymptomatic confirmed by post\-Fontan procedure transthoracic echocardiogram, or other imaging techniques, during the screening period of the study
- •2\. History of gastrointestinal disease or surgery associated with clinically relevant impaired absorption
- •3\. History of or signs/symptoms suggestive of protein\-losing enteropathy
- •4\. Active bleeding or high risk for bleeding contraindicating antiplatelet or anticoagulant therapy,
- •including a history of intracranial bleeding
- •5\. Indication for anticoagulant or antiplatelet therapy other than current study.
- •6\. Chronic use of nonsteroidal anti\-inflammatory drugs (NSAIDs)
- •7\. Platelet count \<50 x 109/L at screening
- •8\. Creatinine clearance (CrCl) \<30 mL/min/1\.73m2
- •9\. Known clinically significant liver disease (eg, cirrhosis, acute hepatitis, chronic active hepatitis, or alanine aminotransferase (ALT) \>3x upper limit of normal (ULN) with concurrent total bilirubin
结局指标
主要结局
未指定
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