PRO-ACT: Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 6
- 主要终点
- Proportion of Participants With HCV RNA Level Below Limits of Quantification (LOQ)
研究概览
简要总结
In this study, subjects that do not have Hepatitis C virus (HCV) will be transplanted with livers or kidneys from donors who do have HCV. Medications that are used to treat HCV will be given to the study subjects shortly after transplant to protect them from developing the problems HCV can cause to the liver.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥ 18 year-old), wait-listed for primary kidney or liver transplant without a potential suitable living donor or for simultaneous liver kidney transplant;
- •HCV non-infected at the time of transplant. Subjects who were previously HCV infected but who have had documented SVR12 are eligible to participate;
- •Agree to use two methods of birth control during the study;
- •Donor characteristics: serum HCV NAT-positive and negative for hepatitis B surface antigen. For liver transplant: pre-donation liver biopsy with no fibrosis (F0) or minimal fibrosis (F1). For kidney transplant: kidney donor profile index < 85%.
排除标准
- •Donor and/or recipient HIV infection
- •Subject pregnant or nursing
- •Donor and/or recipient Hepatitis B surface antigen positive
- •Kidney-pancreas transplant
- •Single organ liver recipients who received hemodialysis for more than 7 days prior to liver transplantation
- •Kidney recipients: on dialysis for > 5 years at time of Screening; subjects sensitized with panel reactive antibody > 80%; for single organ kidney transplant, subjects with advanced liver fibrosis (Knodell stage 3) or cirrhosis
- •Individuals being treated with and needing to continue rifabutin, rifampin, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St. John's wort (Hypericum perforatum), medium- or high-dose rosuvastatin or atorvastatin, or high-dose proton pump inhibitors (See Concomitant Medications).
- •Individuals treated with amiodarone within 42 days of organ transplant.
研究组 & 干预措施
Treatment Arm
Single Arm: Sofosbuvir/Velpatasvir
Dosage: 400mg/100mg. Once daily for 12 weeks.
干预措施: Sofosbuvir/Velpatasvir (Drug)
Treatment Arm
Single Arm: Sofosbuvir/Velpatasvir
Dosage: 400mg/100mg. Once daily for 12 weeks.
干预措施: Sofosbuvir/Velpatasvir/Voxilaprevir (Drug)
结局指标
主要结局
Proportion of Participants With HCV RNA Level Below Limits of Quantification (LOQ)
时间窗: 12 weeks after end of treatment
The primary outcome was sustained virologic response, defined as HCV RNA below the lower limit of quantification 12 weeks after treatment completion (SVR12). Secondary outcomes included the proportion of patients with SVR24 defined as HCV RNA \< lower limit of quantification 24 weeks after the end of treatment; with viral relapse defined as HCV RNA \<LLOQ at end of treatment with subsequent quantifiable HCV RNA; and with on-treatment virologic breakthrough defined as \> 1 log increase in viral RNA after treatment week 1. Safety was measured as the adverse events and serious adverse events attributed by the investigator to HCV infection or antiviral therapy; the proportion of recipients who prematurely discontinued antiviral therapy before the planned end of treatment; and patient and graft survival at 6 months post-transplant.
次要结局
- Safety as Measured by the Proportion of Participants Who Prematurely Discontinue Antiviral Therapy Before the Planned End of Treatment(12 weeks after start of treatment)