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临床试验/NCT03382847
NCT03382847已完成4 期

A Single-center Pilot Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Heart Transplant Recipients With Post-transplant Treatment of Hepatitis C Viremia With Mavyret

NYU Langone Health2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年1月5日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
25
试验地点
2
主要终点
Sustained Virologic Response After Treatment

研究概览

简要总结

Study subjects active on the waiting list for a heart transplant at the NYU Langone Transplant Institute who are hepatitis C (HCV) negative will receive a heart transplant from a donor who tests positive for HCV. The study will entail surveillance for the development of HCV viremia post-transplant. Patients who develop HCV viremia post-transplant will be treated with an FDA-approved, pan-genotypic direct acting antiviral drug, Mavyret. Patients who are treated with Mavyret will be monitored for clearance of viremia and for sustained virologic response.

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

性别
All
接受健康志愿者

入选标准

  • Listed for an isolated heart transplant at NYU Langone Health
  • 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 50kg
  • 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

排除标准

  • HIV positive
  • HCV RNA positive or history of previously treated HCV
  • Hepatitis B surface antigen positive or on active antiviral treatment for HBV
  • Pregnant or nursing (lactating) women
  • Use of strong CYP3A inducers

结局指标

主要结局

Sustained Virologic Response After Treatment

时间窗: 1 year

Percentage of patients with sustained virologic response after treatment for HCV after heart transplant.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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