GANCICLOVIR & ORAL VALGANCICLOVIR, ORAL & IV GANCICLOVIR IN LIVER TRANSPLANT

更昔洛韦

• 批准号: 6264989
• 负责人: CARLOS V PAYA
• 金额: $ 2.01万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6264989
• 关键词: antiviral agents; clinical research; clinical trial phase I; dosage; ganciclovir; human subject; human therapy evaluation; intravenous administration; liver transplantation; microorganism disease chemotherapy; oral administration; pharmacokinetics

A total of 3 patients were enrolled in this phase I multicenter trial evaluating the pharmacokinetics of po valganciclovir. Results from these 3 patients are to be pooled with a total of 25 patients recruited worldwide to define the dose of valganciclovir that is comparable to either 5 mg/kg IV ganciclovir or 3 mg po qd of oral ganciclovir. The 3 patients were studied without any significant side effects and all the sample collection and evaluation was satisfactory. The study is complete.

共有3例患者参加了这项评价口服缬更昔洛韦药代动力学的I期多中心试验。 将这3例患者的结果与全球招募的25例患者合并，以确定与5 mg/kg IV更昔洛韦或3 mg po qd口服更昔洛韦相当的缬更昔洛韦剂量。 3例患者均接受了研究，无任何明显副作用，所有样本采集和评估均令人满意。 研究已经完成。