既往治疗过的严重 B 型血友病的 I/II 期研究-猫眼课题宝

既往治疗过的严重 B 型血友病的 I/II 期研究

批准号：

6278964

负责人：

AMY SHAPIRO

金额：

$1.68万

依托单位：

INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS

依托单位国家：

美国

项目类别：

财政年份：

1997

资助国家：

美国

项目状态：

已结题

起止时间：

1997-12-01 至 1998-11-30

来源：

https://reporter.nih.gov/project-details/6278964

关键词：

blood disorder chemotherapy clinical research clinical trial phase I coagulation factor IX hemophilia B human subject human therapy evaluation pharmacokinetics recombinant proteins

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英文摘要

The primary objectives of the study are to assess the safety and efficacy of rhFIX in previously treated patients. Secondary objectives are to estimate the pharmacokinetic parameters, including recovery and half-life, of rhFIX administered as an intravenous infusion, to evaluate the pharmacokinetic parameters of rhFIX in comparison to pooled human plasma product Mononine to evaluate the efficacy and safety of rhFIX in treating acute bleeding episodes and to evaluate the efficacy and safety of rhFIX in controlling bleeding during and after surgical procedures.

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