SH229 Tablets Combined With Daclatasvir Dihydrochloride Tablets in Treatment Adult Patients With Chronic Hepatitis C

Summary

Phase II: Exploring the efficacy and safety of different doses of SH229 tablets combined with fixed-dose Daclatasvi dihydrochloride (DCV) tablets in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a basis for the design and implementation of phase III clinical trials. Phase III: Confirmation of the efficacy and safety of SH229 tablets combined with Daclatasvi dihydrochloride (DCV) tablets in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a sufficient basis for drug registration and clinical use.

Timeline

Start

2019-03-29

Primary completion

2019-12

Completion

2020-08

Publications

• Hua R, Kong F, Li G, Wen X, Zhang Y, Yang X, Meng C, Xie W, Jiang Y, Wang X, Han X, Huang Y, Mao Q, Wang J, Guan Y, Chen J, Ma Y, Xiong Q, Ma H, Yan X, Rao H, Zhao Y, Sun T, Zhu L, Mao X, Lian J, Deng G, Xin Y, Wang Y, Ye Y, Xu B, Gao H, Tan Y, Li D, Yang D, Su M, Zhang X, Min J, Shi X, Wei L, Niu J. Alfosbuvir plus Daclatasvir for Treatment of Chronic Hepatitis C Virus Infection in China. Infect Dis Ther. 2023 Nov;12(11):2595-2609. doi: 10.1007/s40121-023-00872-4. Epub 2023 Oct 19.
• Hua R, Kong F, Wen X, Xiong Q, Chen J, Meng C, Ma H, Tan Y, Huang Y, Jiang Y, Guan Y, Mao X, Wang J, Xin Y, Gao H, Xu B, Li C, Wu Q, Zhang X, Wang Z, Zhao L, Zhang Y, Li G, Niu J. Efficacy and safety of alfosbuvir plus daclatasvir in Chinese patients with hepatitis C virus genotypes 1, 2, 3, and 6 infection: An open-label, phase 2 study. J Viral Hepat. 2022 Jun;29(6):455-464. doi: 10.1111/jvh.13650. Epub 2022 Apr 8.

Drugs

Indications