NCT07706166尚未招募4 期
An Interventional Study of Letermovir for Primary Prophylaxis of Cytomegalovirus Infection in Moderate Risk (R+) Abdominal Solid Organ Transplant Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Efficacy of letermovir as a prophylaxis of CMV
研究概览
简要总结
The purpose of this clinical trial is to find out whether a medication, called letermovir, can help prevent a virus called cytomegalovirus (CMV) in participants who receive a kidney or liver transplant and who have already been exposed the CMV.
Participants will take letermovir for 84 days.
详细描述
This study is being done to see if letermovir prevents CMV reactivation in seropositive participants with a kidney or liver transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Adults who are at moderate risk for CMV after transplant (CMV IGG+, including D+/R+ or D-/R+)
- •Adults who received a kidney transplant, liver transplant, or any combination thereof
排除标准
- •Known contraindication to letermovir or its excipients
- •Current participation in another CMV related study
- •Unwilling or unable to participate in the study protocol
研究组 & 干预措施
Receive letermovir
Experimental
Participants will take letermovir
干预措施: Letermovir (Drug)
结局指标
主要结局
Efficacy of letermovir as a prophylaxis of CMV
时间窗: 84 days
Efficacy will be measured through comparative rates of antiviral failure. Failure will be defined as withdrawal due to intolerance or breakthrough viral replication to a viral load \>1000 IU/mL.
次要结局
- Percentage of participants who develop cytomegalovirus-specific cell-mediated immunity(84 days)
研究者
研究点 (1)
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