HEPATITIS C CLINICAL TRIAL-CLINICAL CENTERS

该项目旨在开发实用、安全和有效的方法来预防慢性丙型肝炎病毒(丙型肝炎病毒)感染患者的肝病进展。大约800名慢性丙型肝炎患者对阿尔法干扰素治疗无效(使用或不使用利巴韦林)，并在肝脏活检中有明显的纤维化，将参加一项持续长期抗病毒治疗(长达四年)的有效性和安全性研究。该试验的目的是评估长期抗病毒治疗的持续治疗是否可以减缓肝病的进展，预防肝硬变或防止肝硬变恶化、失代偿、肝细胞癌(肝细胞癌)的发展和死于肝病。该试验还将评估丙型肝炎的自然病史以及预测或与疾病进展相关的因素。主要的焦点将是评估抗病毒治疗，尽管不能根除丙型肝炎病毒，但是否可以抑制肝细胞的损伤、坏死和纤维化。以前接受过α干扰素治疗但没有持续的病毒学和生化反应的慢性丙型肝炎患者将有资格进入试验。

This project is aimed at developing practical, safe and effective means of preventing the progression of liver disease in patients with chronic hepatitis C virus (HCV) infection. Approximately 800 patients with chronic hepatitis C who have failed to respond to therapy with alpha interferon (with or without ribavirin) and who have significant fibrosis on liver biopsy will be enrolled in a study of the efficacy and safety of a continuous long-term antiviral therapy (for as long as four years). The objective of the Trial is to evaluate whether continuous therapy with long-term antiviral therapy can slow the progression of liver disease, preventing cirrhosis or preventing worsening of cirrhosis, decompensation, development of hepatocellular carcinoma (HCC) and death from liver disease. The Trial will also evaluate the natural history of hepatitis C and the factors that predict or correlate with disease progression. The major focus will be to evaluate whether antiviral therapy, despite not leading to eradication of HCV, can suppress hepatocellular injury, necrosis and fibrosis. Patients with chronic hepatitis C who have previously been treated with alpha interferon without a sustained virological and biochemical response will be eligible to enter the Trial.