Prevention of Transmission of Hepatitis C Virus (HCV) From HCV-Viremic Organ Donor to HCVNegative Organ Transplant Recipient - Pilot Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Percentage of participants with Sustained Virological Response
研究概览
简要总结
This trial will be done in participants who undergo transplantation of heart, kidney or lung at University of California, San Diego (UCSD) and receive a hepatitis C infected donor organ. In this trial, the plan is to start hepatitis C treatment just before transplant surgery and treat for a short one-week course to see if hepatitis C infection can be prevented in the transplant recipient. The plan is to perform this trial in 10 participants and if successful, the next step is to try to make it standard of care as prevention of infection is better than treating hepatitis C after discharge from transplant surgery (which is usually a 12 week standard treatment).
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 aged 18 years or greater
- •participants actively listed for heart, lung and/or kidney transplant
- •participants have already consented to receive HCV-viremic organs as part of the institution's clinical practice protocol (involves education and informed consent), and are able to sign informed consent for this research study.
排除标准
- •participants who have a prior history of HCV infection regardless of treatment status, pre-existing human immunodeficiency virus (HIV) or hepatitis B virus (HBV) infection
- •participants who are not able to sign informed consent for this research study
- •participants who have not agreed to accept HCV+ organs as part of the UCSD clinical practice protocol
- •participants who are listed for a liver transplant (either as a single organ or combined organ transplant).
研究组 & 干预措施
Treatment Arm
干预措施: glecaprevir/pibrentasvir (GLE/PIB) (Drug)
结局指标
主要结局
Percentage of participants with Sustained Virological Response
时间窗: 91 days
The primary outcome is the percentage of patients sustained virological response (SVR) at day 91 after completion of a 7-day course of GLE/PIB.
次要结局
- Percentage of participants with treatment-related Serious Adverse Events(91 days)
研究者
Saima Aslam
Associate Professor
University of California, San Diego