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

Abstract

Abstract: 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 American 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.

Key words: chronic hepatitis B, new medicinal products, design of clinical trials

YANG Huan. Guidance for the evaluation and design of clinical trials of new medicinal products in treatment of chronic hepatitis B[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2008, 13(2): 121-130.

References

[1] 中华医学会肝病学分会, 中华医学会感染病学分会. 慢性乙型肝炎防治指南[J]. 中华内科杂志, 2006, 45(2):162-170.
[2] 庄辉. 加强慢性乙型肝炎的抗病毒治疗[J]. 中华实验和临床病毒学杂志, 2007, 21(2):101.
[3] EMEA. Guideline on the Clinical Evaluation of Medicincal Products Intended for Treatment of Hepatitis B, Adoption by CHMP[S]. February. 2006.
[4] Lok AS, Mc Mahon BJ. AASLD Practice Guidelines: Chronic hepatitis B[J]. Hepatology, 2007, 45(2):507-539.
[5] 贾继东, 郑欢伟. 慢性乙型肝炎抗病毒治疗的新规范[J]. 药品评价, 2007, 4(3):129-130.
[6] 罗生强, 张玲霞. 美国2007 年慢性乙型肝炎临床实践指南介绍[J]. 中华肝脏病杂志, 2007, 15(6):477-480.
[7] 陈国民, 袁平戈. 免疫药物在乙型病毒性肝炎中的作用[J]. 药品评价, 2007, 4(3):146-149.
[8] Perrillo RP, Gish RG, PetersM, et al. Chronic hepatitis B:a critical appraisal of current approaches to therapy[J]. Clin Gastroenterol Hepatol, 2006, 4(2):233-248.
[9] Perrillo RP. Therapy for hepatitis B-viral suppression or eradication[J]. Hepatelogy, 2006, 43(Suppl 1):S182-S193.
[10] Liaw YF, Leung N, Guan R, et al. Asian-Pacific consensus statement on the management of chronic hepatitis B:a 2005 update[J]. Liver Int, 2005, 25(3):472-489.
[11] Lok AS, McMahon BJ, Practice Guildelines Committee, et al. Chronic hepatitis B:update of recommendations[J]. Hepatology, 2004, 39(3):857-861.
[12] 中华医学会传染病与寄生虫病学分会、肝病学分会. 病毒性肝炎防治方案[J]. 中华肝脏病杂志, 2000, 8(6):342-329.
[13] Lin YL. Clinical trial design issues for chronic hepatitis B[J]. Drug Inf J, 2004, 38(3):287-291.
[14] 卫生部药政局. 抗肝炎药物临床研究指导原则[M]//新药(西药)临床及临床前研究指导原则汇编. 1993:21-27.