EUCTR2015-000962-76-SE进行中（未招募）1 期
Single-dose study testing a rivaroxaban dry powder formulation for oral suspension in children from 6 months to 12 years with previous thrombosis - Phase 1 granules for oral suspension
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Children with an age between 6 months and <12 years who
- •have completed anticoagulant treatment at least 10 days prior
- •to the planned study drug administration
- •2. Normal prothrombin time (PT) and activated partial
- •thromboplastin time (aPTT) within 10 days prior to planned
- •study drug administration
- •3. Written informed consent provided and, if applicable, child
- •assent provided
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 48
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Active bleeding or high risk for bleeding, contraindicating
- •anticoagulant therapy
- •2. Planned invasive procedures, including removal of central
- •lines, within 24 hours before and after single dose intake
- •3. An estimate glomerular filtration rate (eGFR)
- •< 30 mL/min/1.73m2
- •4. Hepatic disease which is associated either with: coagulopathy
- •leading to a clinically relevant bleeding risk, or alanine
- •aminotransferase (ALT) > 5x upper limit of normal (ULN), or
- •total bilirubin > 2x ULN with direct bilirubin > 20% of the
- •5. Platelet count < 50 x 109/L
- •6. Hypertension defined as systolic and/or diastolic blood
- •pressure >95th percentile for age)
- •7. Concomitant use of strong inhibitors of both CYP3A4 and
- •P-glycoprotein, e.g., all human immunodeficiency virus
- •protease inhibitors and the following azole-antimycotic
- •agents: ketoconazole, itraconazole, voriconazole, and
- •posaconazole, if used systemically (fluconazole is allowed)
- •8. Concomitant use of strong inducers of CYP3A4, e.g.,
- •rifampicin, rifabutin, phenobarbital, phenytoin and
- •carbamazepine
- •9. Inability to cooperate with the study procedures
- •10. Hypersensitivity to rivaroxaban
- •11. Participation in a study with an investigational drug other than
- •rivaroxaban or a medical device within 30 days prior to
研究者
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