HEPATITIS C CLINICAL TRIAL-CLINICAL CENTERS

丙型肝炎临床试验临床中心

• 批准号: 6077034
• 负责人: Jules Leonard Dienstag
• 金额: $ 15.24万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-05-01 至 2007-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6077034
• 关键词: HEPATITIS; CLINICAL; TRIAL; CENTERS

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.

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（HCV）感染患者的肝脏疾病进展。 大约800名对α干扰素治疗（联合或不联合利巴韦林）无效且肝活检显示明显纤维化的慢性丙型肝炎患者将参加一项连续长期抗病毒治疗（长达4年）的疗效和安全性研究。该试验的目的是评估长期抗病毒治疗的连续治疗是否可以减缓肝病的进展，预防肝硬化或预防肝硬化恶化，失代偿，肝细胞癌（HCC）的发展和肝病死亡。 该试验还将评估丙型肝炎的自然史以及预测疾病进展或与疾病进展相关的因素。 主要的重点将是评估抗病毒治疗，尽管不能根除HCV，是否可以抑制肝细胞损伤，坏死和纤维化。 既往接受过α干扰素治疗且无持续病毒学和生化应答的慢性丙型肝炎患者将有资格进入试验。