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临床试验/NCT04508907
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

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年9月10日最近更新:
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

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bashar Aqel

Principal Investigator

Mayo Clinic

研究点 (1)

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