A Prospective Single-Arm Observational Study of Maribavir for the Treatment of Post Hematopoietic Stem Cell Transplantation Cytomegalovirus Infection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- CMV viremia clearance rate
研究概览
简要总结
The main aim of this study is to check the effectiveness and safety of maribavir for the treatment of CMV infection after HSCT in Chinese patients in real-world settings.
The participants will be treated with maribavir for up to 8 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hematopoietic Stem Cell Transplant Recipients
- •Adult patients with an expected survival of ≥4 weeks.
- •Confirmed CMV infection, including CMV viremia and CMV disease.
- •Fully understand the content of the trial, voluntarily participate and complete the trial, and voluntarily sign the informed consent form.
排除标准
- •Participants who meet any of the following criteria are not eligible for this study:
- •Patients currently participating in other CMV-related clinical studies, such as those receiving anti-CMV drug treatment or involved in CMV vaccine clinical studies.
- •At screening, liver function tests show: AST > 5×ULN, or ALT > 5×ULN, or total bilirubin ≥ 3.0×ULN.
- •Patients with psychiatric disorders or severe psychological conditions that may affect the ability to provide informed consent or participate in follow-up consultations.
- •Participants deemed unsuitable for inclusion by the investigator.
研究组 & 干预措施
Participants with CMV Infection
Participants will receive maribavirv tablets, 400 mg, orally twice a day(bid) for up to 8 weeks treatment period.
干预措施: maribavir (Drug)
结局指标
主要结局
CMV viremia clearance rate
时间窗: At Week 4
The proportion of patients who had confirmed clearance of CMV viremia in plasma (defined as two consecutive CMV-DNA tests below the preemptive treatment threshold after treatment) after 4 weeks of treatment.
CMV disease remission rate
时间窗: At Week 4
The proportion of patients who achieved remission of CMV disease after 4 weeks of treatment.
次要结局
- Number of participants with AEs(From first dose of study drug up to week 8)
- CMV DNA undetected time(From first dose of study drug up to week 8)
- CMV viremia clearance at the end of 8 weeks of treatment(At Week 8)
- Number of participants with all-cause mortality(From first dose of study drug up to week 8)