Non-interventional, Prospective Study to Evaluate the Impact of CMV Replication Over Hepatitis C Recurrence in Liver Transplant Recipients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 179
- 试验地点
- 13
- 主要终点
- Effect of CMV replication over hepatitis C recurrence
研究概览
简要总结
The relationship between cytomegalovirus infection and recurrence of hepatitis C in liver transplant recipients remains controversial. Although some studies (Teixeira et al., 2000; Singh et al., 2005)have not found an association between recurrence of hepatitis C and CMV infection, studies such as Rosen et al. show that 50% of patients with CMV infection suffered cirrhosis durig follow-up period, while between not-infected patients the rate was 11%. To clarify this question, a non-interventional study will be carried out in order to assess if CMV replication is a risk factor for graft dysfunction in liver transplant recipients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Men or women who underwent liver transplantation after hepatopathy caused by HCV, confirmed by pre-transplantation detection of HCV RNA
- •Age > 18 years old
排除标准
- •Patients co-infected with HBV or HIV
- •Patients who show other causes of liver disease
结局指标
主要结局
Effect of CMV replication over hepatitis C recurrence
时间窗: 48 weeks after transplantation
viral charge of HCV will be assessed 48 weeks after transplantation
次要结局
- Effect of CMV replication over fibrosis in graft after Hepatitis C recurrence after transplantation(1 year)
- Effect of CMV recurrence over graft and patient survival(1 year)
- Relationship between viral charge of CMV and HCV during study period(1 year)