A Single-center Pilot Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Incidences of Viremia After Receiving a Lung Transplant From a Donor Who Tests Positive for Hepatitis C
研究概览
简要总结
Patients who are Hepatitis C Negative (HCV negative) and are on the waiting list for a lung transplant at NYULH who consent to participate in this study will receive a lung transplant from a deceased donor that is HCV positive. Patients will initiate treatment for HCV with the pan-genotypic agent, Mavyret, on the day of surgery and will complete the full 8-week treatment course. Patients will be monitored post-transplant for the development of viremia, and for the time course of clearance of viremia among those who develop viremia.
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
- 是
入选标准
- •Recipient criteria:
- •Listed for an isolated lung transplant at NYU Langone Health
- •Between 18-70 years of age
- •Able to travel to the NYU Langone Health for routine post-transplant visits and study visits for a minimum of 6 months after transplantation
- •No active illicit substance abuse
- •Weight at least 40kg
- •Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to the increased risk of birth defects and/or miscarriage
- •Both men and women must agree to use at least one barrier method after transplant to prevent any secretion exchange
- •Able and willing to provide informed consent
- •Donor criteria:
- •Detectable HCV RNA by nucleic acid test (NAT) or positive anti-HCV antibody
- •Donor lung meets standard NYU Langone Health clinical criteria for procurement
排除标准
- •Recipient criteria:
- •HIV positive
- •HCV RNA positive or history of previously treated HCV
- •Evidence of active hepatitis B infection or on active antiviral treatment for HBV
- •Pregnant or nursing (lactating) women
- •Use of strong CYP3A inducers
- •Requires multi-organ transplant
- •Donor criteria:
- •Confirmed HIV positive
- •Confirmed HBV positive (positive hepatitis B surface antigen, and/or detectable Hepatitis B virus DNA)
- •Known previously failed treatment for HCV
- •Donor age >60 years
研究组 & 干预措施
Post Lung Transplant Patients
The lung transplantation will be performed per standard of care techniques,and all post-transplant management of the transplanted organ, including immunosuppression, will be carried out per standard of care.
干预措施: Mavyret (Drug)
结局指标
主要结局
Number of Incidences of Viremia After Receiving a Lung Transplant From a Donor Who Tests Positive for Hepatitis C
时间窗: 24 Months
Surveillance for the development of hepatitis C viremia post-transplant
Number of Patients With Sustained Virologic Response After Treatment
时间窗: 24 Months
HCV serologic testing to evaluate the presence of immunity to HCV or the evidence of prior infection with HCV.
次要结局
未报告次要终点