治疗慢性乙型肝炎创新性药物的临床试验设计及关注要点

Guidance for the evaluation and design of clinical trials of new medicinal products in treatment of chronic hepatitis B

由乙型肝炎病毒(HBV)感染造成的疾病负担是全球、尤其是我国面临的一大难题,慢性乙型肝炎治疗药物的研发领域近年正处于快速发展阶段。本文参考了美国肝病协会(AASLD)、欧洲肝病协会(EASL)、亚太地区肝病协会(APASL)最新有关对慢性乙型肝炎治疗的共识、欧盟抗乙型肝炎病毒治疗药物临床评价指南和我国的慢性乙型肝炎防治指南,针对我国慢性乙型肝炎创新性药物临床试验设计中关注的问题和临床研究如何评价提出建议和交流。

The global, especially our country＇s burden of disease of hepatitis B virus （HBV） is a difficult problem to us. Prospects for the development of new anti-HBV drugs in treatment of chronic hepatitis B have improved substantially during the last decade. The practice guidelines for chronic hepatitis B developed by the Ameriean Association for the Study of Liver Diseases （AASLD）, the European Association for the Study of the Liver （EASL）, and the Asian Pacific Association for the Study of the Liver （APASL） have been reviewed. Guideline on the clinical evaluation of medicinal products intended for treatment of hepatitis B and the practice guidelines for chronic hepatitis B have been studied. This article provided recommendations and discussions for sponsors on evaluation and design of clinical trials of new medicinal products in treatment of chronic hepatitis B.