Hepatitis C Positive Organ to Recipient Hepatitis C Negative Longitudinal Transplant Study (HERCULES)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Time to Transplant
研究概览
简要总结
Compare wait list mortality and time to liver, heart or kidney transplant for registrants listed to consider allografts from Hepatitis C Virus (HCV) Nucleic Amplification Testing (NAT)+ donors versus those who are not . The umbrella protocol has been set up to include heart and kidney transplant recipients.
详细描述
The research project will take place within each transplant center and can be incorporated into routine pre- and post-transplant care (i.e., no extra visits are needed). Enrolling in this study will enable patients to accept offers of HCV NAT+ livers, in addition to the regular waitlist. All other transplant eligibility criteria have to be met per routine care. The multi-site project will establish a biorepository and prospective data collection with the goal of obtaining more generalizable results than single-center studies alone can.
Patients who enroll in the study but receive an HCV- organ instead, will be (data collection only) as part of the study.
Aims are to evaluate sustained virologic response (SVR) rates post-transplant with Direct Acting Anti-Viral (DAA) therapy, as well as long-term patient and graft outcomes.
Evaluate the financial impact of timely transplant and DAA therapy compared to traditional wait time health care expenditure.
Create a blood and tissue biorepository for future evaluation of HCV NAT+ allografts and their outcomes
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients > or = 18 years of age
- •Actively listed for Liver Transplant (LT) or Simultaneous Liver and Kidney (SLK)
- •Current HCV NAT- status
- •Review by multi-disciplinary transplant team that patient is appropriate for listing for HCV NAT+ liver offers
排除标准
- •Unwilling to consent to post transplant DAA therapy
- •Hepatitis B Virus (HBV) viremia
- •Donor Inclusion Criteria:
- •Deceased Donor organs
- •HBV cAb donors will be considered on a case by case basis based on specific recipient factors and plan for post-transplant prophylaxis
- •Donor Exclusion Criteria:
- •Bilirubin >3
- •Positive nucleotide testing for HBV
- •Radiographic, laboratory or other clinical evidence of portal hypertension
- •Fibrosis on pre-procurement liver biopsy fibrosis > F1 or fibroscan >7 (if both are done and discordant, use biopsy to determine eligibility
结局指标
主要结局
Time to Transplant
时间窗: 5 years
Number of days between date of adding patient to the waitlist and transplant date comparing waitlist registrants listed to accept HCV NAT+ donor organs with those followed per standard of care (not accepting HCV NAT+ donor organs).
次要结局
- Wait list Mortality(5 years)