JPRN-jRCT2021200029进行中(未招募)3 期
A0003 Eye Drops 0.55% Phase III Study in Cystinosis Patients
Ito Shuichi0 个研究点目标入组 14 人开始时间: 2020年12月7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
- 14
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
- ot applicable 至 ot applicable(—)
- 性别
- All
入选标准
- •Considered by the investigator or the sub-investigator being eligible for study participation, based on the results of screening tests conducted within 8 weeks before administration of A0003 Eye Drops 0.55%
- •Whose leukocyte cystine concentration measured before initiation of Cysteamine treatment was > 1 nmol/1/2 cystine/mg protein or who was diagnosed with cystinosis
- •Cystine crystal deposits in whose cornea was detected by slit lamp examination conducted at screening tests
- •Has ability to or intend to comply with the 4 times daily instillation regimen
排除标准
- •Patients who have used Cysteamine eye drops within 1 year before administration of A0003 Eye Drops 0.55%
- •Patients with uncontrolled hepatic disorder, cardiovascular disease, neurologic disease, or a cancer complication
- •Patients with a history of hypersensitivity to Cysteamine, benzalkonium chloride, disodium edetate, carmellose sodium, citric acid monohydrate, or penicillamine
研究者
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