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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6
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
- 年龄范围
- 2 至 11（—）
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
- •>1.5x ULN with direct bilirubin >20% of the total at screening)
- •10. Known contraindication to ASA (subjects participating in Part B only)
- •11. Known allergies, hypersensitivity, or intolerance to rivaroxaban or its excipients
- •12. Inability to cooperate with study procedures
- •13. Combined P-glycoprotein (P-gp) and strong cytochrome P450 3A4 (CYP3A4) inhibitors (such as but not limited to ketoconazole, telithromycin, or protease inhibitors) use within 4 days before enrollment, or planned use during the study. Itraconazole use within 7 days before enrollment or
- •planned use during the study.
- •14. Combined P-gp and strong CYP3A4 inducers (such as but not limited to rifampin/rifampicin,
- •rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, or St. John's Wort) use within
- •2 weeks before enrollment, or planned use during the study.
- •15. Planned use of drugs that are moderate CYP3A4 inhibitors (such as erythromycin) during the Initial PK, PD, and Safety Assessment Period of Part A only
- •16. Participation in a clinical study with an investigational drug or medical device in the previous 30 days prior to enrollment
- •17. Any condition for which, in the opinion of the investigator, participation would not be in the best
- •interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the
- •protocol-specified assessments
- •18. Family member of an employee of the investigator or study site with direct involvement in the
- •proposed study or other studies under the direction of that investigator or study site.
研究者
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