The Effectiveness and Safety of TMF in the Treatment of Chronic Hepatitis B Patients With Normal ALT.

Summary

This is a multicenter, randomized, open, blank controlled trial ，in order to evaluate the effectiveness and safety of Amibufenamide（TMF） in the treatment of chronic hepatitis B virus infection patients with normal ALT .

Timeline

Start

2022-06-08

Primary completion

2024-04-30

Completion

2028-04-30

Outcome

Met primary endpoint

paper the TMF group achieved HBV DNA levels <20 IU/mL compared with the control group (74.2% vs. 9.0%, P < 0.001). PMID 40937079 ↗

Publications

• Background 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.
• Results Gui H, Shen Y, Tan L, Hu P, Qian F, Wu X, Qiu Y, Zheng S, Lv J, Shi Y, Li J, Jiang Y, Hu Z, Nie F, Huo Y, Qu L, Xie Q. Interim Analysis of 48-week Tenofovir Amibufenamide Treatment in Chronic Hepatitis B Patients with Normal Alanine Aminotransferase Levels: The PROMOTE Study. J Clin Transl Hepatol. 2025 Jul 28;13(7):568-577. doi: 10.14218/JCTH.2025.00162. Epub 2025 Jun 30.

Drugs

Indications