A Proof of Concept Study of Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of Participants With Undetectable HCV RNA at SVR12
研究概览
简要总结
Proof of concept, open-label single center study for the donation of HCV positive kidneys to HCV negative patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.
详细描述
The study objective is to determine if the administration of grazoprevir and elbasvir (with or without ribavirin) for 12-16 weeks after kidney transplantation prevents the spread of HCV infection from a donor kidney with known HCV genotype 1 or 4 infection to a HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post 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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must meet Massachusetts General Hospital (MGH) transplant center criteria and already be listed for isolated kidney transplant
- •No available living kidney donor
- •Has ≤ 730 days (two years) of accrued transplant waiting time if blood type A and ≤ 1095 days of accrued transplant waiting time if blood type B or O.
- •On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate <15mL/min/1.73m2 at the time of screening
- •Weight ≥ 50kg
- •Serum alanine transaminase (ALT) within normal limits
排除标准
- •AB blood type
- •Body mass index (BMI > 35
- •History of liver disease
- •Pregnant or nursing (lactating) women
- •Cardiomyopathy (LV ejection fraction < 50%)
- •Positive crossmatch or positive donor specific antibodies
- •Human immunodeficiency virus (HIV) positive
- •Hepatitis C virus (HCV) RNA positive
- •Hepatitis B virus (HBV) surface antigen positive
- •Any contraindication to kidney transplant per MGH center protocol
研究组 & 干预措施
Elbasvir/grazoprevir for HCV+ kidney transplant recipients
Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor
Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV).
干预措施: elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) (Drug)
结局指标
主要结局
Number of Participants With Undetectable HCV RNA at SVR12
时间窗: 12 weeks post-treatment (24 weeks post-transplant)
Sustained virologic response at 12-weeks post-treatment (SVR12), as defined by negative HCV viral load, after 12-16 weeks of elbasvir/grazoprevir treatment in patients who receive a kidney transplant from a deceased donor infected with HCV.
次要结局
- Number of Subjects With Undetectable Serum HCV RNA at Study Day 7, 14, 28, 56, 84, 112, 168, 252, 365(1 year post transplant)
研究者
Raymond Chung
Director, Hepatology, Massachusetts General Hospital
Massachusetts General Hospital