INTRON A VS INTRON A + RIBAVIRIN IN RELAPSED HEPATITIS C

内含子 A 与内含子 A 利巴韦林治疗复发性丙型肝炎的比较

• 批准号: 6307334
• 负责人: John G. McHutchison
• 金额: $ 2.74万
• 依托单位: SCRIPPS RESEARCH INSTITUTE, THE
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2001-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6307334
• 关键词: clinical research; clinical trials; combination chemotherapy; hepatitis C; hepatitis C virus; human subject; human therapy evaluation; immunotherapy; interferon alpha; microorganism disease chemotherapy; relapse /recurrence; ribavirin

This study addresses the efficacy and safety of interferon alpha-2b compared to interferon alpha-2b and ribavirin in hepatitis C patients who had previously responded to interferon but relapsed after therapy was stopped. The biochemical and virological response to treatment are measured at two time points: at the end of treatment and six months posttreatment sustained response. Secondary endpoints include improvement in liver biopsy at posttreatment, time to response and time to relapse. Based on these markers, this randomized clinical trial preliminary data suggests the treatment with combined therapy brings improvement in sustained responses of 50-60% compared to 26-30% of interferon alpha 2b alone. Future studies will focus on the need to provide optimal treatment during the initial course of therapy based on the finding that retreatment of initial responders who relapse is associated with a lower end of treatment response than previously reported.

本研究探讨了干扰素α-2b与干扰素α-2b和利巴韦林在既往对干扰素有反应但停药后复发的丙型肝炎患者中的疗效和安全性。 在两个时间点测量对治疗的生物化学和病毒学应答：治疗结束时和治疗后6个月的持续应答。 次要终点包括治疗后肝活检的改善、至缓解时间和至复发时间。 基于这些标志物，这项随机临床试验的初步数据表明，与单独使用干扰素α 2b的26-30%相比，联合治疗的持续应答改善了50-60%。 未来的研究将重点关注在初始疗程期间提供最佳治疗的必要性，这是基于复发的初始应答者的再治疗与治疗应答终点低于先前报告的结果。