EUCTR2018-002984-24-GB进行中（未招募）1 期
Open-label, Single-arm, Multicenter Study to Assess the Safety of Cystadrops® in Pediatric Cystinosis Patients from 6 Months to Less Than 2 Years Old [SCOB2 Study] - SCOB2
RECORDATI Rare Diseases SAR0 个研究点目标入组 5 人开始时间: 2019年7月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patient aged from 6 months to less than 2 years old
- •2.Cystinosis diagnosed patients confirmed by the physician and with presence of corneal cystine crystal deposits assessed during ophthalmic examination
- •3.Evidence of a signed and dated informed consent document indicating that parents/ legally acceptable representatives had been informed of all pertinent aspects of the study (if required by regulation)
- •4.Parents/ legally acceptable representatives who are willing to comply with regular visits and ophthalmic exams
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Contraindications to any of the Cystadrops® components
- •2.Participation in another ophthalmic investigational study or intent to participate during the course of the study
- •3.Any medical condition that would, in the opinion of the Investigator, interfere with the evaluation of the study objectives
研究者
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