Expanding the Pool in Lung Transplantation: The Use of Hepatitis C Positive Donor Lungs in Hepatitis C Negative Recipients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- HCV Viremia
研究概览
简要总结
To perform a study (20 patients) utilizing Hepatitis C positive (HCV Ab+/NAT -) donor lungs for hepatitis C negative recipients with post-operative surveillance and treatment only if a recipient infection occurs.
详细描述
The investigators are proposing a study of efficacy, in which positive donors will be used for HCV negative patients. Following lung transplantation patients will undergo HCV antibody, virus PCR, and liver function testing. Recipients whom test positive for HCV viremia for 2 consecutive tests at any point will complete 12 weeks of Sofosbuvir/velpatasvir therapy.
This initial study would enroll 20 patients and utilize donors that are young, otherwise healthy whom are Hepatitis C antibody positive but Nucleic Acid Amplification Testing (NAT) negative (HCV Ab+/NAT-). The recipients would be limited to those patients who have previously consented to receive a high risk lung transplant, consented to participant in this study, and who are physiologically optimized for transplantation (e.g., low risk for lung transplantation).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who sign the informed consent for this study
- •Patients whom agree to receive a PHS high risk organ
- •Patients listed for heart transplantation
- •Age 18-65
排除标准
- •Patients who do not sign informed consent for this study
- •HIV Seropositivity
- •HBV Seropositivity (HBcAb and/or HBsAg positive)
- •Abnormal liver enzymes - 3 times the normal liver function values (Bilirubin, INR, AST, ALT)
- •Acute or chronic renal insufficiency (creatinine clearance <50 ml/min) or history of dialysis
- •Patients on ECMO
- •Respiratory insufficiency requiring mechanical respiratory support (ventilator, BiPAP)
- •Liver insufficiency
- •Prior history of hepatitis C
- •Allergy to Sofosbuvir/velpatasvir
- •Pregnancy
研究组 & 干预措施
Lung Transplant
Patients will be transplanted with HCV positive lung. Recipients whom test positive for HCV viremia for 2 consecutive tests at any point will complete 12 weeks of Epclusa (Sofosbuvir/velpatasvir).
干预措施: Epclusa (Drug)
结局指标
主要结局
HCV Viremia
时间窗: at 2 years
Incidence of HCV Viremia
Liver Function Testing
时间窗: at 2 years
Assessment of Hepatic function
Seroconversion
时间窗: at 2 years
Rate of HCV seroconversion
Survival
时间窗: at 2 years
Survival rates
次要结局
- Rejection(at 2 years)
- Waitlist(at 2 years)
研究者
Pablo Sanchez
Assistant Professor
University of Pittsburgh