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临床试验/JPRN-jRCT2021200029
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

发起方
Ito Shuichi

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