Early Treatment With Sofosbuvir (SOF) and Ledipasvir (LDV) to Prevent HCV Recurrence After Liver Transplantation (OLT)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Sustained Virological Response (SVR12)
研究概览
简要总结
The study is a single centre, single arm, open-label, proof of concept study enrolling 20 adult primary liver transplant recipients with genotype 1 HCV infection. Subjects will receive Sofosbuvir (SOF) and Ledipasvir (LDV) starting at time of liver transplantation (OLT) and continues for 12 weeks. Subjects will be receive 24 week post-treatment follow up.
详细描述
Hepatitis C viral infection (HCV) leading to end-stage liver disease is the leading indication for liver transplant worldwide. HCV recurrence following liver transplantation is universal, associated with 100-fold increase in viremia levels, and runs at an accelerated course, leading to graft cirrhosis in up to 30% of patients within 5 years. Successful eradication of HCV post transplant normalizes the long term survival of HCV positive liver transplant recipients. This study aims to treat HCV infection starting at the time of transplant. The study is a single centre, single arm, open-label,proof of concept study enrolling 20 adult primary liver transplant recipients with genotype 1 HCV infection. Subjects will receive Sofosbuvir (SOF) 400 mg and Ledipasvir (LDV) 90 mg as a fixed dose combination (FDC) tablet starting at time of liver transplantation (OLT) and continues for 12 weeks. Subjects will receive 24 week post-treatment follow up. The study will investigate if the patient has achieved sustained virological response (SVR) 12 weeks after cessation of treatment (SVR12). Furthermore, safety and efficacy of this treatment regimen beginning at the time of transplant will be investigated.
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
- •Recipient of a first (primary) live or deceased (after brain or cardiac death) donor liver transplant
- •Willing and able to provide written informed consent
- •Male or Female, age 18-70 years old
- •Medical MELD score ≤30 at time of transplant (calculated based on serum bilirubin, creatinine and INR, i.e. not taking exception points into account)
- •Quantifiable HCV RNA at time of listing or transplant evaluation
- •HCV genotype 1a or 1b infection
- •Female patients must have a negative pregnancy test at enrolment
排除标准
- •Liver re-transplantation
- •Recipients of multiple solid organ transplants
- •Estimated GFR <30ml/min at time of transplant
- •Participants transplanted for fulminant hepatic failure
- •Participants co-infected with HBV or HIV
- •Previous treatment with a Sofosbuvir or Ledipasvir containing regimen
- •Participation in an interventional clinical trial within 1 month prior to enrolment
- •Known allergies or hypersensitivity to Sofosbuvir or Ledipasvir
- •Pregnancy and/or lactation
研究组 & 干预措施
SOF and LDV
Single arm: All participants will be started on Sofosbuvir (SOF) 400 mg and Ledipasvir (LDV) 90 mg as a fixed dose combination (FDC) tablet p.o. once daily with or without food starting at the time of liver transplantation (OLT), i.e. first doses given immediately prior to OLT, and continuing for 12 weeks.
干预措施: Sofosbuvir (SOF) and Ledipasvir (LDV) (Drug)
结局指标
主要结局
Sustained Virological Response (SVR12)
时间窗: 12 weeks after cessation of treatment
Defined as HCV RNA in serum below lower limit of quantification (LLOQ)
次要结局
- Sustained Virological Response (SVR24)(24 weeks after cessation of treatment)