Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection

Summary

A multi-center, randomized, double-blind, bismuth-containing quadruple active comparator-controlled Phase 3 clinical study to evaluate the efficacy and safety of Rifasutenizol in combination with rabeprazole and amoxicillin in the primary treatment of participants with H. pylori infection using an adaptive design with sample size re-estimation.

Timeline

Start

2023-05-18

Primary completion

2023-12-24

Completion

2024-03-26

Outcome

Met primary endpoint

paper In the modified intention-to-treat analysis, the H pylori eradication rate in the RTT group was non-inferior to that in the BCTT group PMID 40945526 ↗

Publications

• Song Z, Zhou L, Wang W, Lan C, Tang T, Xie J, Fan H, Wang X, Zuo X, Zhu Y, Liu C, Gu Y, Feng H, Gao X, Zhang Q, Zhang H, Chen J, Geng G, Ma Z; EVEREST-HP Study Group. Rifasutenizol-based triple therapy versus bismuth plus clarithromycin-based triple therapy for first-line treatment of Helicobacter pylori infection in China (EVEREST-HP): a phase 3, multicentre, randomised, triple-dummy, double-blind, controlled, non-inferiority trial. Lancet Infect Dis. 2026 Jan;26(1):101-110. doi: 10.1016/S1473-3099(25)00438-4. Epub 2025 Sep 10.

Drugs

Indications