NCT05593588进行中（未招募）2 期
Senolytics as a Novel Treatment for Interstitial Lung Disease in Common Variable Immunodeficiency (CVID)
Avni Joshi1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年4月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in immunophenotyping of peripheral T lymphocytes
研究概览
简要总结
The purpose of this study is to determine if the supplement, Fisetin, can be used as a treatment option for common variable immunodeficiency (CVID) by comparing its efficacy to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have received a diagnosis of CVID according to the international consensus document (ICON) at least 30 days before enrollment.
- •Physician diagnosis of possible GLILD associated with CVID.
- •IgA results.
- •Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile. (A negative pregnancy test for women whose menopausal status is determined by self-reported absence of menstrual periods in the past 12 months will be required within 72 hours prior to randomization).
- •Patient must be able and willing to comply with the requirements of this study protocol.
排除标准
- •Unable or unwilling to give informed consent.
- •Presence of any condition that the Investigator or the subject's attending physician believes would put the subject at risk or would preclude the patient from successfully completing the trial.
- •Pregnant and/or lactating. Women of childbearing potential (WCBP) must have a negative pregnancy test within 72 hours prior to randomization.
- •WCBP who are unwilling to abstain from sex or use an adequate method of contraception from the time of the first IP administration through 48 hours after the last IP administration.
- •Men who are unwilling to abstain from sex with WCBP or use an adequate method of contraception from the time of the first IP administration through 48 hours after the last IP administration.
- •Prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia.
- •Patient currently hospitalized or under immediate consideration for hospitalization.
- •Current use of tobacco products or as per clinical judgement.
- •Current excessive caffeine intake (400 mg or more per day).
研究组 & 干预措施
Placebo Group
Placebo Comparator
Subjects will receive placebo for 2 cycles of 2 consecutive days (first on days 0 & 1 and then repeated on days 28 & 29)
干预措施: Placebo (Drug)
Fisetin Group
Experimental
Subjects will receive the supplement, Fisetin, for 2 cycles of 2 consecutive days (first on days 0 & 1 and then repeated on days 28 & 29)
干预措施: Fisetin (Drug)
结局指标
主要结局
Change in immunophenotyping of peripheral T lymphocytes
时间窗: Baseline, 6 months
Measured by percentage of activated CD4+25+ T cells
次要结局
- Change in 6 minute walk test(Baseline, 6 months)
- Change in radiologic imaging in subjects(Baseline, 3 months, 6 months)
- Adverse Events(6 months)
- Change in quality of life(Baseline, 6 months)
- Use of MRI imaging for assessment of GLILD(6 months)
- Infectious complications(6 months)
- Change in Forced Vital Capacity (FVC)(Baseline, 6 months)
研究者
Avni Joshi
Regulatory Sponsor and Principal Investigator
Mayo Clinic
研究点 (1)
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