Current status and considerations of clinical development of new drugs for the treatment of hepatitis D
10.13699/j.cnki.1001-6821.2024.03.033
- VernacularTitle:丁型病毒性肝炎治疗新药临床研发现状及考量
- Author:
Shu-Ning ZUO
1
;
Jian-Zhong ZHAO
Author Information
1. 国家药品监督管理局药品审评中心,北京 100163
- Keywords:
hepatitis D virus;
chronic hepatitis D;
new drug development;
clinical trial design
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(3):464-471
- CountryChina
- Language:Chinese
-
Abstract:
Relative to hepatitis B virus(HBV)monoinfection,HBV/hepatitis D virus(HDV)co-infection may be associated with more severe liver disease,leading to increased rates of cirrhosis,hepatocellular carcinoma,hepatic decompensation,and liver failure.The treatment of chronic HDV infection is essential and urgent.No drugs with established Efficacy and safety data have been approved for the treatment of chronic HDV infection.There are several new drugs are in clinical development stage now.We review the mechanism of action,research and development progress,and clinical trial design of new drugs currently in the clinical development stage,as well as the recommendations of regulatory agencies and academia for the clinical trial design of new drugs for the treatment of chronic HDV infection.And discuss the key points of confirmatory clinical trial design.
