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 名患者参加了这项 I 期多中心试验，评估 po 缬更昔洛韦的药代动力学。 这 3 名患者的结果将与全球招募的总共 25 名患者进行汇总，以确定缬更昔洛韦的剂量，该剂量与 5 mg/kg IV 更昔洛韦或 3 mg po qd 口服更昔洛韦相当。 3名患者接受了研究，没有出现任何明显的副作用，所有样本采集和评估均令人满意。 研究已经完成。