NCT04508907进行中(未招募)4 期
Pilot Study for the Use of Shortened Preemptive Therapy With Glecaprevir/Pibrentasvir (G/P) and Ezetimibe in Hepatitis C Seronegative Solid Organ Transplant Recipients (Kidney, Heart, Lung and/or Pancreas) of Hepatitis C Viremic Donors
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中(未招募)
- 发起方
- Mayo Clinic
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Rate of prevention of HCV viremia in recipients of HCV viremic solid organs
研究概览
简要总结
This study is being done to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1: Pre-emptive Treatment Arm
Experimental
Single arm study were all recipients of HCV viremic organs will receive combination therapy.
干预措施: Mavyret (Drug)
结局指标
主要结局
Rate of prevention of HCV viremia in recipients of HCV viremic solid organs
时间窗: 3 months
The study will assess the percentage of patient who will not become HCV viremic using this preemptive treatment protocol.
Graft and patient survival
时间窗: 1 year
Study will assess the overall 1 year patient and graft survival.
次要结局
未报告次要终点
研究者
研究点 (1)
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