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

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.

NCT Number	NCT06760065
Lead Sponsor	Sixth Affiliated Hospital, Sun Yat-sen University Collaborators: Guangzhou First People's Hospital, The Seventh Affiliated Hospital of Sun Yat-sen University, Longgang District People's Hospital of Shenzhen, Eighth Affiliated Hospital, Sun Yat-sen University, Shenzhen Baoan District People's Hospital, Foshan Fuxing Chancheng Central Hospital
Conditions	Helicobacter Pylori Infection Helicobacter Pylori Eradication Patient Education
Enrollment	316 participants
Start Date	2025-01-15
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-01-09