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
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To determine the safety of ITX 5061 in liver transplant recipients
研究概览
简要总结
This is a phase I pilot study to determine the safety and preliminary efficacy of a novel hepatitis C virus (HCV) entry inhibitor (ITX 5061) in patients with HCV infection undergoing liver transplantation.
详细描述
Hepatitis C virus (HCV) infection is common and treatment options at present are limited. Recurrence of HCV infection after liver transplantation is inevitable and disease progression is rapid when compared with disease in the non-transplanted liver.
Studies of ITX 5061 in vitro have shown it to be a potent inhibitor of HCV entry into hepatocytes, through blocking the interaction of the virus with scavenger receptor BI suggesting it may reduce graft re-infection rates after liver transplant.
There are no studies of treatments to block host receptors for HCV and the investigators hypothesize that ITX 5061 will modulate HCV kinetics in the early phase post liver transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old, ≤ 65 years old
- •Plasma HCV RNA positive at time of listing for liver transplantation
- •Accepted for liver transplantation for any of:
- •End-stage liver disease due to HCV infection
- •End-stage liver disease due to HCV infection and alcohol related liver disease (ALD)
- •HCC due to HCV
排除标准
- •Refusal or inability to give informed consent
- •Viral co-infection with either hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •Pregnancy or breastfeeding
- •Women, of child-bearing potential, who are not willing to practice effective contraception
- •Men, sexually active with women of child-bearing potential, who are not willing to practice effective contraception
- •Any situation that in the Investigator's opinion may interfere with optimal study participation
- •Participation in any clinical study of an investigational agent within 30 days of recruitment
- •Transplantation with a donor organ from a HCV positive individual
研究组 & 干预措施
ITX 5061
Liver Transplantation as per Standard of Care + ITX5061
干预措施: ITX 5061 (Drug)
结局指标
主要结局
To determine the safety of ITX 5061 in liver transplant recipients
时间窗: 90 days
Safety will be assessed by determination of the frequency of: * perioperative events: including transfusion requirements and vasopressor requirements * post-operative events: including primary graft non-function, hepatic artery thrombosis, acute cellular rejection and infective complications
次要结局
- To determine whether any change in early viral kinetics is sustained(90 days)
- To determine whether treatment leads to an alteration in HCV RNA kinetics in the first week after liver transplantation(One week)