JPRN-jRCT2051190075进行中（未招募）3 期
Efficacy and safety of Valganciclovir in patients with symptomatic congenital cytomegalovirus disease: A multicenter, open-label, single-arm study
ozu Kandai0 个研究点目标入组 25 人开始时间: 2019年11月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
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
- >= 3weeks old 至 <= 2month old（—）
- 性别
- All
入选标准
- •(1)Confirmation of CMV nucleic acid from urine by PCR tests within 21days of age
- •(2)Symptomatic congenital CMV disease, as central nervous system by one or more of the following
- •1)Microcephaly
- •2)Hydrocephalus / Ventricular enlargement
- •3)Periventricular calcification
- •4)Cortical hypoplasia / white matter disorder.
- •5)Retinal choroiditis
- •6)Abnormal ABR
- •(3)<60 days of age at informed consent
- •(4)Gestational age > 32 weeks at birth
- •(5)Weight at study enrolment > 1,800 grams
- •(6)Signed informed consent from parent(s) or legal guardian(s)
排除标准
- •(1)Patients with bacterial infection requiring antibiotics
- •(2) Documented renal insufficiency, as noted by a creatinine clearance > 1.5 mg/dl at time of study enrollment
- •(3)Anencephalopathy and hydrocephalus by other causes
- •(4)Neutrophil count < 500/mm3 or the Platelet count < 25,000/mm3
- •(5)Infants known to be born to women who are HIV positive and HIV positive infants
- •(6)Patients who are judged as inappropriate by a study investigator or sub-investigators.
研究者
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