NL-OMON36556撤回不适用
Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Paediatric Subjects with an Indwelling Central Venous Catheter - CV185-079
Bristol-Myers Squibb0 个研究点目标入组 4 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 4
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 17（—）
入选标准
- •1) Signed Written Informed Consent obtained from subject or subject*s legally acceptable representative (parents or guardians) according to local regulations and if mentally capable, assent from subject if required locally.
- •2) Subjects with stable disease with any type of functioning CVC in the upper or
- •lower venous system (e.g., jugular, subclavian; femoral vein) that is anticipated to
- •remain in the subject for the treatment portion of the study.
- •3) Male and female subjects > 37 weeks to <18 years of age
排除标准
- •1) Current or recent (within 3 months of study drug administration) gastrointestinal
- •disease or gastrointestinal surgery that could impact the absorption of the study drug (i.e. severe diarrhoea, ileus, or malabsorption syndrome).
- •2) Inability to tolerate oral medication or administration of medication via an enteral
- •3) Inability to tolerate central venous access.
- •4) Heparin-coated CVC
- •5) History or evidence of abnormal bleeding or coagulation disorder including those
- •in a first-degree relative
- •6) Any condition, in the opinion of the investigator, for which surgery is needed or
- •administration of an anticoagulant is contraindicated.
- •7) Presently receiving or the need for ongoing treatment with an anticoagulant or
- •antiplatelet agent.
- •8) Treatment with a potent inhibitor or inducer of CYP3A4 or P-gp within 2 weeks
- •of enrolment.
- •9) Any other sound medical, psychiatric and/or social reason as determined by the
- •investigator.
- •10) Abnormal baseline lab test findings as defined by the protocol
- •11) Evidence of organ dysfunction or any clinically significant deviation from normal
- •in physical examination, vital signs, or clinical laboratory determinations beyond
- •what is consistent with the target population.
- •12) History of allergy to apixaban or Factor Xa inhibitors or any other significant drug allergy (such as anaphylaxis or hepatotoxicity).
- •13) History of significant adverse reaction or major bleeding related adverse reaction
- •to other anticoagulant or antiplatelet agents
研究者
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