PEG IFN VS ROFERON A FOR CHRONIC HEPATITIS C WITH CIRRHOSIS

PEG IFN 与 ROFERON A 治疗慢性丙型肝炎伴肝硬化的比较

• 批准号: 6307380
• 负责人: PAUL J POCKROS
• 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/6307380
• 关键词: chronic disease /disorder; clinical research; dosage; hepatitis C; human subject; human therapy evaluation; immunotherapy; interferon alpha; liver cirrhosis; liver disorder chemotherapy; polyethylene glycols

This study compares the safety and efficacy of 2 doses (90 and 180 micrograms) of PEG-interferon alpha-2a given once a week with a standard thrice weekly regimen of 3MIU of Roferon-A in cirrhotic patients with chronic hepatitis C. In a subgroup of patients, PEG-IFN pharmacokinetics will be evaluated by repeated blood sampling over the first week after the first injections, monthly during the treatment period, and for 2 weeks after the final injection.

本研究比较了慢性丙型肝炎肝硬化患者每周一次注射 2 剂（90 微克和 180 微克）的 PEG-干扰素 α-2a 与每周三次 3MIU Roferon-A 的标准治疗方案的安全性和有效性。在一个患者亚组中，将通过在第一次注射后第一周内重复采血来评估 PEG-IFN 药代动力学， 治疗期间每月一次，以及最后一次注射后两周。