NCT04041843已完成2 期
A Pilot Study of an Oral Anticoagulant "Apixaban" for theTreatment of Venous Thromboembolism in Children and Adolescents
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- venous thromboembolism (VTE) formation
研究概览
简要总结
Patients who have developed a venous thrombosis will receive apixaban to treat and prevent a secondary thromboembolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents with a newly diagnosed primary VTE.
- •Treatment with apixaban has to begin within 72 hours of the diagnosis of VTE.
- •Patients who have received heparin at the beginning of their diagnosis and are willing to switch to apixaban, are allowed to do so within 72 hours of their treatment. Patients who are switched to apixaban are not allowed to receive any other systemic anticoagulant therapy.
- •VTE confirmed by diagnostic imaging.
- •Children with body weight of ≥ 40 kg and are able to tolerate medication by mouth or administered via an NG or GT tube.
- •Adequate liver function: AST and/or ALT <5 times ULN, and/or Direct bilirubin <2 times ULN
- •Platelet count of at least ≥ 30,000/ul.
- •Adequate renal function: >30% of GFR for age
- •Female subjects of childbearing potential must not be nursing or pregnant with negative urine pregnancy test within 72 hours prior to dosing with study medication.
- •Signed written informed consent
排除标准
- •Current or recent (within 3 months) apixaban administration.
- •Patient is unable to tolerate medications by oral route or by n/g administration, peptic ulcer disease, intestinal obstruction, toxic megacolon, typhlitis, or short gut syndrome.
- •History of primary bleeding disorder and first degree family history of bleeding disorder.
- •Active bleeding or high risk of bleeding at the time of study entry.
- •History of significant head injury and/or any history of intracranial hemorrhage.
- •Conditions predispose to intracranial bleed; e.g. brain tumor, brain metastasis.
- •Uncontrolled Grade 3 or 4 severe hypertension.
- •History of allergy to apixaban or factor Xa inhibitors.
研究组 & 干预措施
Abixaban
Experimental
Apixaban 10 mg twice daily p.o. for seven days followed by 5 mg twice daily p.o. for children and adolescents weighting ≥40 kg who have been diagnosed with a thrombosis.
干预措施: Apixaban (Drug)
结局指标
主要结局
venous thromboembolism (VTE) formation
时间窗: 7-90 days
No new VTE
次要结局
- Doppler ultrasound vein imaging(day 8-15)
研究者
研究点 (1)
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