Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of HCV recurrence post-transplant
研究概览
简要总结
This study will test the safety and tolerability of HCV Entry Inhibitor ITX 5061 in Liver Transplant Recipients with Hepatitis C infection. The investigators hypothesize that ITX 5061 oral monotherapy will be safe in adults during and after liver transplantation and that therapy will also inhibit HCV infection of newly transplanted livers in adults with prior HCV infection.
详细描述
All subjects will receive 28 days of ITX 5061 beginning at the time of transplant.
Dosing of ITX 5061 is as follows:
Day of Transplant prior to surgery: ITX 5061 300 mg Day of Transplant following surgery: ITX 5061 300 mg Post-Operative Days 1-6: ITX 5061 300 mg Post-Operative Days 7-27: ITX 5061 150 mg
Subjects will be monitored for HCV RNA levels, HDL cholesterol and ITX 5061 drug concentration levels.
A liver biopsy will be performed at 6 months post-transplant to assess for histological signs of HCV recurrence.
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 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-72
- •Patients accepted onto waiting list for liver transplantation for HCV related liver disease and receiving a deceased donor liver allograft
- •HCV RNA (+) at time of listing for transplantation. All HCV genotypes will be eligible
- •Patients with HCC and those receiving hepatitis B core (+) donor livers will be eligible
- •Standard immunosuppression protocol with tacrolimus, corticosteroid taper, and mycophenolate mofetil
排除标准
- •Viral co-infection (HBV/HIV)
- •Receipt of a HCV (+) donor allograft
- •Patients undergoing retransplantation for recurrent HCV
- •Multivisceral transplantation
- •Patients receiving anti-viral therapy at the time of LT
- •Live donor liver transplantation
研究组 & 干预措施
ITX 5061
Subjects will receive ITX 5061 for 28 days beginning at the time of liver transplantation for hepatitis C virus. 300mg will be administered on the day of surgery and for one week post transplant, followed by 150mg for an additional 21 days.
干预措施: ITX 5061 (Drug)
结局指标
主要结局
Incidence of HCV recurrence post-transplant
时间窗: 28 days
We hypothesize that ITX 5061 oral monotherapy will be safe in adults during and after liver transplantation and will inhibit HCV infection of newly transplanted livers in adults with prior HCV infection. The number of treated subjects who are infected at 28 days post-transplant will be compared to the historical control rate (95%).
次要结局
- Viral dynamics of serum HCV RNA(24 hours post-transplant)
- Change in serum HCV RNA(3 months after transplant)
- Levels of ITX 5061(28 days)
- Potential changes in plasma HCV E2(28 days)