Study of the Efficacy and Safety of HS-10234 in Patients With Chronic Hepatitis B Virus Infection

Summary

The primary objective of this study is to compare the safety and efficacy of HS-10234 versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with chronic hepatitis B virus (HBV) infection.

Timeline

Start

2018-08-16

Primary completion

2020-05-31

Completion

2024-06-07

Publications

• Liu ZH, Jin QL, Zhang YX, Gong GZ, Wu GC, Yao LF, Wen XF, Gao ZL, Huang Y, Yang DK, Chen EQ, Mao Q, Lin SD, Shang J, Gong HY, Zhong LH, Yin HF, Wang FM, Hu P, Zhang XQ, Gao QJ, Xia P, Li C, Niu JQ, Hou JL; TMF Study Group. [Safety profile of tenofovir amibufenamide therapy extension or switching in patients with chronic hepatitis B: a phase Ⅲ multicenter, randomized controlled trial]. Zhonghua Gan Zang Bing Za Zhi. 2024 Oct 20;32(10):893-903. doi: 10.3760/cma.j.cn501113-20240807-00366. Chinese.
• Liu ZH, Jin QL, Zhang YX, Gong GZ, Wu GC, Yao LF, Wen XF, Gao ZL, Huang Y, Yang DK, Chen EQ, Mao Q, Lin SD, Shang J, Gong HY, Zhong LH, Yin HF, Wang FM, Hu P, Zhang XQ, Gao QJ, Jin CN, Li C, Niu JQ, Hou JL; TMF Study Group. [Efficacy evaluation of extending or switching to tenofovir amibufenamide in patients with chronic hepatitis B: a phase Ⅲ randomized controlled study]. Zhonghua Gan Zang Bing Za Zhi. 2024 Oct 20;32(10):883-892. doi: 10.3760/cma.j.cn501113-20240807-00365. Chinese.
• Liu Z, Jin Q, Zhang Y, Gong G, Wu G, Yao L, Wen X, Gao Z, Huang Y, Yang D, Chen E, Mao Q, Lin S, Shang J, Gong H, Zhong L, Yin H, Wang F, Hu P, Wu Q, Pan C, Jia W, Li C, Sun C, Niu J, Hou J; TMF Study Group. 96-Week Treatment of Tenofovir Amibufenamide and Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients. J Clin Transl Hepatol. 2023 Jun 28;11(3):649-660. doi: 10.14218/JCTH.2022.00058. Epub 2022 Nov 1.
• Liu Z, Jin Q, Zhang Y, Gong G, Wu G, Yao L, Wen X, Gao Z, Huang Y, Yang D, Chen E, Mao Q, Lin S, Shang J, Gong H, Zhong L, Yin H, Wang F, Hu P, Xiao L, Li C, Wu Q, Sun C, Niu J, Hou J; TMF Study Group. Randomised clinical trial: 48 weeks of treatment with tenofovir amibufenamide versus tenofovir disoproxil fumarate for patients with chronic hepatitis B. Aliment Pharmacol Ther. 2021 Nov;54(9):1134-1149. doi: 10.1111/apt.16611. Epub 2021 Sep 29.

Drugs

Indications