HEPATITIS C CLINICAL TRIAL-CLINICAL CENTERS

本项目旨在开发实用、安全、有效的手段 预防慢性肝病患者肝病进展的研究 丙型肝炎病毒(HCV)感染。大约800名患者患有 对阿尔法治疗无效的慢性丙型肝炎患者 干扰素(与利巴韦林联合或不与利巴韦林联合使用)和有显著纤维化的患者 将参加一项关于肝活检的有效性和安全性的研究 持续的长期抗病毒治疗(长达四年)。这个 该试验的目的是评估持续治疗与 长期的抗病毒治疗可以减缓肝病的进展， 预防或防止肝硬变恶化，失代偿， 肝细胞癌的发生与肝性死亡 疾病。该试验还将评估肝炎的自然病史。 C和预测疾病进展或与疾病进展相关的因素。这个 主要的焦点将是评估抗病毒治疗是否，尽管不是 导致根除丙型肝炎病毒，可以抑制肝细胞损伤， 坏死和纤维化。患有慢性丙型肝炎的患者 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.