Comparison of Keverprazan Hydrochloride-Amoxicillin Dual Therapy and Susceptibility-Guided Quadruple Therapy for Helicobacter Pylori Rescue Treatment

• Status: NOT_YET_RECRUITING
• Trial end date: 2027-12-31

Summary

This study aims to evaluate the efficacy and safety of Keverprazan Hydrochloride combined with Amoxicillin in dual therapy compared to susceptibility-guided quadruple therapy in the treatment of Helicobacter pylori (H. pylori) infections requiring rescue therapy. H. pylori is a common infectious disease associated with peptic ulcers, gastric cancer, and mucosa-associated lymphoid tissue lymphoma. However, the increasing resistance of H. pylori to antibiotics has reduced the eradication rates of standard therapies.

Potassium-competitive acid blockers (P-CABs), such as Keverprazan Hydrochloride, provide faster and more sustained gastric acid suppression compared to traditional proton pump inhibitors (PPIs), making them a promising option for H. pylori treatment. This multicenter, randomized controlled trial will provide critical evidence comparing the effectiveness of Keverprazan-based dual therapy to susceptibility-guided quadruple therapy, aiming to establish optimized rescue therapy guidelines for H. pylori eradication.

• Phase: PHASE3

Details

• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Collaborators: Bao'an District People's Hospital of Shenzhen; Eighth Affiliated Hospital, Sun Yat-sen University; Foshan Fuxing Chancheng Central Hospital; Guangzhou First People's Hospital; Longgang District People's Hospital of Shenzhen; The Seventh Affiliated Hospital of Sun Yat-sen University
• Treatments: Amoxicillin