NCT06605378招募中不适用
A Cross-Sectional, Observational Study of the Prevalence of Adenoviral-Specific Antibodies and Inflammatory Cytokines in Participants With Chronic Granulomatous Disease
Ensoma57 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2024年11月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 57
- 主要终点
- Total adenoviral-specific antibody (TAb) titer
研究概览
简要总结
This research study is designed to assess the prevalence of specific antibodies and inflammatory cytokines in adult and pediatric participants with CGD.
详细描述
In this observational study, blood samples will be collected from adult and pediatric patients with CGD. The level of circulating adenovirus antibodies and inflammatory cytokines will be measured to characterize the prevalence of these markers in this population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant must have been diagnosed with CGD based on the referring physician's confirmation that NADPH oxidase activity is ≤5% (i.e., the percentage of dihydrorhodamine-positive [DHR+] cells is ≤5% by flow cytometry) OR based on confirmed pathogenic mutation in a CGD associated gene (CYBB, CYBA, NCF1, NCF2, NCF4, or CYBC1).
- •The participant or the participant's legally authorized guardian or representative (if applicable) must be capable of giving signed informed consent.
- •The participant (with assistance from the participant's legally authorized guardian/representative or primary caregiver, if applicable) must be capable of complying with the requirements and restrictions listed in the protocol and informed consent form (ICF).
排除标准
- •The participant has undergone an allogeneic bone marrow transplant or investigational gene therapy.
- •The participant is unable to comply with the sample collection procedure based on investigator judgment.
结局指标
主要结局
Total adenoviral-specific antibody (TAb) titer
时间窗: 1 Day
Level of total adenoviral-specific antibody in blood
Adenoviral-specific neutralizing antibody (NAb) titer
时间窗: 1 Day
Level of adenoviral-specific neutralizing antibodies in blood
次要结局
- Circulating inflammatory cytokine levels(1 Day)
研究者
研究点 (57)
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