NCT05072912终止不适用
Screening Study to Identify Patients With Complement Factor I Deficiencies
Catalyst Biosciences1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2021年7月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Complement Factor I Deficiency Identification
研究概览
简要总结
This is screening study to identify patients with Complement Factor I deficiencies. The primary objective is to identify participants with CFI deficiencies and assess the prevalence in the screened population.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An individual must meet all the following criteria to be eligible to participate in this study:
- •A male or female ≥6 months of age who has been diagnosed with a complement-mediated disease in which a reasonable etiological association with CFI deficiency has been reported
- •Affirmation of participant's informed consent or LAR's willingness to provide informed consent with signature confirmation before any study-related activities. (Study-related activities are any procedures that would not have been performed during normal clinical management of the participant.) The participant (if a minor) must be willing to give written informed assent if the minor is within the age groups 7 to 11 years old and 12 to 17 years old.
排除标准
- •Diagnosis of age-related macular degeneration that is complement-related with no concurrent systemic complement involvement
结局指标
主要结局
Complement Factor I Deficiency Identification
时间窗: At Screening
Identification of participants with a CFI deficiency and percentage of those with a CFI deficiency versus total number of screened participants
次要结局
- Demographics, Disease Characteristics, Medication Use(At Screening)
研究者
研究点 (1)
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