Clinical considerations in the design of clinical trial for innovative hepatitis B drugs
10.3760/cma.j.cn501113-20200722-00412
- VernacularTitle:乙型肝炎创新药物临床试验设计的临床考量
- Author:
Junqi NIU
1
;
Hong ZHANG
;
Hong YOU
;
Yanhua DING
;
Ruihua DONG
;
Jinlin HOU
;
Jidong JIA
Author Information
1. 吉林大学第一医院肝胆胰内科&I期药物临床试验病房，长春 130021
- Keywords:
Hepatitis B;
Drug;
Clinical trial design
- From:
Chinese Journal of Hepatology
2020;28(8):654-657
- CountryChina
- Language:Chinese
-
Abstract:
The research and development of chronic hepatitis B (CHB) therapeutic drugs has been undergoing rapid development in recent years in order to achieve the World Health Organization's goal of eliminating viral hepatitis as a major public health threat by 2030. The focus of early stage clinical trials (including the first human trial) is the selection of subjects, study design, dose selection, administration method, dose escalation, monitoring, observation and reporting procedures for adverse events/reactions (tolerability evaluation), and criteria for subjects to continue and discontinue administration. Therefore, quantitative pharmacology knowledge is required to analyze the relationship between in vivo drug exposure, efficacy and adverse reactions, and the inclusion of exploratory indicators such as HBV RNA, hepatitis B virus core-related antigen (HBcrAg), etc., to analyze the mechanism and target of innovative drugs and the efficacy of cccDNA in anti-hepatocytes. On the other hand, Phase II-III clinical trials prioritize the optimal dose, efficacy and safety indicators to verify the efficacy and safety of new drugs in a wider range of subjects. This paper refers to the relevant domestic and foreign literature, combined with the author's practical experience in early clinical research, and then briefly introduces the clinical issues that should be paid attention to in the design of clinical trials of CHB innovative drugs.
