IV HBIG PHARMACOKINETIC STUDY

IV HBIG 药代动力学研究

• 批准号: 6279433
• 负责人: TIMOTHY L PRUETT
• 金额: $ 3.19万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6279433
• 关键词: clinical research; clinical trial phase I; hepatitis B; human subject; human therapy evaluation; immunoglobulins; immunotherapy; intravenous administration; liver transplantation; pharmacokinetics

A new intravenous preparation of hepatitis B immune globulin (HBIG) will be compared to the currently marketed intramuscular product. Both drugs will be infused intravenously in a double blinded crossover design to determine the pharmacokinetic elimination of the anti-HBs activity from patient serum. This data will be evaluated to determine the appropriate dosing of the new product for use in hepatitis B liver transplant recipients.

一种新的静脉注射B型肝炎免疫球蛋白（HBIG）制剂， 与目前市售的肌内注射产品进行比较。 两种药物 将以双盲交叉设计静脉输注， 测定抗-HBs活性的药代动力学消除， 病人血清 将对这些数据进行评估，以确定适当的 新产品用于B型肝炎肝移植的剂量 受惠人士