A Single-center Pilot Study Evaluating a Preemptive Short Course of Glecaprevir/Pibrentasvir in Hepatitis C Positive to Negative Kidney Transplantation
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in the Percentage of Incidence of sustained clearance of HCV (cure) 12 weeks after treatment of viremia
研究概览
简要总结
The purpose of this research study is to evaluate the feasibility of a 2 week course of glecaprevir/pibrentasvir (Mavyret) starting immediately prior to transplantation to treat hepatitis C virus (HCV) in kidney transplant recipients who receive a kidney from a donor with HCV.
详细描述
This is a prospective, open-label, single-center, pilot study. The patient population will include 20 patients who are on the kidney transplant waitlist at NYU Langone Health, are hepatitis C virus (HCV) negative, are willing to accept an organ from an HCV positive donor, and consent to participate in this trial. Study subjects will receive a kidney transplant from a deceased donor who tested positive for HCV as confirmed by nucleic acid amplification testing (NAT) per standard of care. All study subjects will receive a two week course of preemptive therapy with glecaprevir/pibrentasvir (Mavyret®), starting on postoperative day (POD) 0 prior to the transplant. If HCV RNA is undetectable after 2 weeks of therapy, Mavyret will be discontinued and study subjects will be followed with an intensive HCV monitoring protocol. If HCV RNA is detectable after 2 weeks of therapy, Mavyret will be continued to complete a full course of 8 weeks per standard of care. All patients will undergo close monitoring and surveillance for HCV viremia post-transplant to ensure that sustained virologic response (SVR) is achieved.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Listed for kidney transplantation at NYU Langone Health and willing to accept HCV positive donor organs
- •Able to complete routine post-transplant visits and study visits for a minimum of 1 year after transplantation
- •Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Stategy (REMS) after transplant due to increased risk of birth defects and/or miscarriage
- •Both men and women must agree to use at least one barrier method of contraception after transplant to prevent any secretion exchange
- •Able and willing to provide informed consent
- •Receive an organ offer for a kidney from a deceased donor that:
- •Is HCV NAT positive
- •Meets all standard criteria for organ acceptability at NYU Langone Transplant Institute
排除标准
- •HCV RNA positive or history of previously treated HCV
- •Evidence of active hepatitis B infection or on active antiviral treatment of HBV
- •HIV positivity
- •Pregnant or nursing (lactacting) women
- •Current use of atazanavir or rifampin
- •Known hypersensitivity to glecaprevir and/or pibrentasvir
- •Current or history of decompensated liver disease
- •Recipients of dual organs (i.e. simultaneous liver and kidney transplant, simultaneous kidney and pancreas transplant, or simultaneous heart and kidney transplant)
- •Receive an organ offer for a kidney from a deceased donor that is:
- •Confirmed HIV positive
- •Confirmed HBV positive (positive hepatitis B surface antigen, and/or detectable hepatitis B virus DNA)
- •Known to have previously failed DAA therapy for treatment for HCV
- •HCV antibody positive, but NAT negative
研究组 & 干预措施
Study group
All study subjects will receive glecaprevir/pibrentasvir (Mavyret®) 300/120 mg orally x 14 days, starting on POD 0 prior to transplantation of the HCV positive kidney. If HCV RNA is detectable after 2 weeks of therapy, Mavyret® will be continued to complete a full course of 8 weeks per standard of care. Safety monitoring and frequent surveillance for HCV viremia will occur for all subjects throughout the duration of the study. The kidney transplantation procedure and routine post-transplant management will be performed per standard of care.
干预措施: Glecaprevir/pibrentasvir (Drug)
结局指标
主要结局
Change in the Percentage of Incidence of sustained clearance of HCV (cure) 12 weeks after treatment of viremia
时间窗: Visit 2 (Day 1) , Visit 3 (Day 3) , Visit 4 (Day 7), Visit 5 (Day 13), Visit 16 (Day 365)
Measured in percentage of patients with SVR after treatment for HCV after kidney transplant. SVR will be defined as the absence of detectable HCV RNA Quantitative (PCR) testing 12 weeks after the completion of the treatment course.
次要结局
- Percentage of Overall patient and graft survival at 1 year post-transplant(Visit 1 (Day 0), Visit 16 (Day 365))
- Change in the Allograft function(Visit 1 (Day 0), Visit 16 (Day 365))
- Time course to transplantation (median)(Screening vist, Visit 1 (Day 0))
- Time course of clearance of viremia after treatment initiation(Visit 1 (Day 0) to Visit 16 (Days 364))
- Percentage of Incidence of treatment failure/treatment resistant strains of HCV(Visit 1 (Day 0), Visit 5 (Day 13), Visit 9 (Day 56))
- Percentage of Incidence and grade of biopsy-proven rejection(Visit 1 (Day 0), Visit 16 (Day 365))
- Percentage of Incidence HCV viremia post-transplant and after 2 weeks of treatment(Visit 1 (Day 0), Visit 5 (Day 13), Visit 16 (Day 365))
- Time course of exposure to development of clinically detectable viremia in those who develop viremia(Visit 1 (Day 0) to Visit 16 (Days 364))