Use of Direct-acting Antiviral Therapy to Prevent Spread of HCV Infection for Patients Receiving a HCV Positive Kidney Transplant as a HCV Negative Recipient
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Undetectable HCV RNA
研究概览
简要总结
Open label single center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.
详细描述
The study objective is to determine if the administration of direct acting antivirals for 12-16 weeks after kidney transplantation prevents the spread of HCV infection from donor kidney with known HCV infection (all genotypes) to an 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
- Non Randomized
- 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
- •Donor meets MGH transplant center criteria and already listed for isolated kidney transplant
- •No available living kidney donor
- •Recipient has ≤ 730 days of accrued transplant waiting time
- •Recipient chronic hemodialysis or peritoneal dialysis
- •Recipient must agree to birth control.
- •°.Weigh ≥ 50kg
- •Serum ALT within normal limits
- •Subject's Insurance company approves payment for DAA therapy post-kidney transplant
排除标准
- •AB Blood type
- •HCV genotype 1
- •BMI > 35
- •Any liver disease in recipient
- •Pregnant or nursing (lactating) women
- •Known allergy or intolerance to tacrolimus that would require administration of cyclosporine
- •Albumin < 3g/dl or
- •Platelet count < 75 x 103/mL
- •Positive crossmatch or positive donor specific antibodies
- •HCV RNA positive
- •Hepatitis B surface antigen positive
- •Patients with primary focal segmental glomerulosclerosis (FSGS)
- •Any contra-indication to kidney transplantation per our center protocol
研究组 & 干预措施
HCV treatment - no viral resistance
Based on the genotype and negative viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier
干预措施: Zepatier (Drug)
HCV treatment - viral resistance
Based on the genotype and positive viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier plus Sofosbuvir
干预措施: Zepatier plus Sofosbuvir (Drug)
结局指标
主要结局
Undetectable HCV RNA
时间窗: 12 weeks post treatment
Negative HCV viral load 12 weeks after last dose of treatment
次要结局
未报告次要终点
研究者
Raymond T. Chung, MD
Director, Hepatology, Massachusetts General Hospital
Massachusetts General Hospital