NL-OMON44043撤回2 期
7-day study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties<br>of oral rivaroxaban in children from birth to less than 6 months with arterial or venous<br>thrombosis - EINSTEIN Junior Phase l/ll in children from birth to less than 6 months.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Bayer
- 入组人数
- 1
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. Children from birth to less than 6 months with documented symptomatic or asymptomatic venous or arterial thrombosis who have been treated with anticoagulant therapy for at least 5 days.
- •2. Gestational age at birth of at least 37 weeks.
- •3. Hemoglobin, platelets, creatinine, ALT and total and direct bilirubin assessed within
- •10 days prior to enrollment.
- •4. Oral feeding/nasogastric/gastric feeding for at least 10 days.
- •5. Informed consent provided.
- •6. Body weight >2600 g.
排除标准
- •1. Active bleeding or high risk for bleeding contraindicating anticoagulant therapy, including history of intra-ventricular bleeding.
- •2. Symptomatic progression of thrombosis during preceding anticoagulant treatment.
- •3. Planned invasive procedures, including lumbar puncture and removal of nonperipherally placed central lines during study treatment.
- •4. Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase (ALT) > 5x upper level of normal (ULN) or total bilirubin (TB) > 2x ULN with direct bilirubin > 20% of the total
- •5. Creatinine > 1.5 times of normal.
- •6. Uncontrolled hypertension defined as > 95th percentile.
- •7. History of gastrointestinal disease or surgery associated with impaired absorption.
- •8. Platelet count <100 x 109/L.
- •9. Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), e.g. all human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically (fluconazole is allowed).
- •10. Concomitant use of strong inducers of CYP3A4, e.g. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine.
- •11. Indication for anticoagulant therapy other than current thrombosis.
- •12. An indication for continued antiplatelet therapy or non-steroid anti-inflammatory drug (NSAID) therapy. Incidental use is allowed.
- •13. Hypersensitivity to rivaroxaban or its excipients.
- •14. Participation in a study with an investigational drug or medical device within 30 days prior to enrollment.
研究者
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