Abstract
The discovery of hepatitis B virus (HBV) has provided a scientific basis for the diagnosis, prevention and treatment of chronic hepatitis B (CHB). The universalization of neonatal hepatitis B vaccine has greatly reduced the HBsAg positive load rate of the Chinese population. Antiviral therapy based on interferon and / or nucleos(t)ide analogues had effectively inhibited HBV replication, improved liver inflammation, liver fibrosis, and reduced the incidence of liver cirrhosis and hepatocellular carcinoma. However, the existing treatment methods can achieve the clinical cure goal of negative HBsAg. In recent years, direct antiviral drugs for HBV life cycle and immunomodulatory drugs for antiviral response have entered an active stage of research and development. Clinical trials that are well-designed, standardized, analyzed, and interpreted are the key to the success of the research and development of a clinical cure for hepatitis B. It is hoped that the experts in hepatology, clinical pharmacology and methodology will work together to promote the research and development process of new drugs for clinical cure of hepatitis B by adopting new clinical trial design, new endpoint indicators, new data management and quality control technology.