Clinical Trial

Optimization of Keverprazan-amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection

Recruiting Phase 3
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Summary
Eradication of HP can significantly improve and reduce HP-related diseases. A 10-14 day quadruple regimen containing bismuth as first-line treatment, achieving an eradication rate of more than 85%. However, some disadvantages of these quadruple regimens, such as severe adverse reactions, high medical costs and low compliance, prevent their application in clinical practice. High-dose proton pump inhibitors (PPI) combined with amoxicillin can be used as the first-line treatment for HP eradication, with good efficacy and compliance and low rate of adverse reactions. However, the acid inhibition effect of PPI mainly depends on the degree of individual metabolism of proton pump,which might influence the eradication effect. Keverprazan, a new competitive potassium acid blocker(P-CAB), is not affected by gene polymorphism, and has the advantage of stronger and longer inhibition effect on gastric acid compared with PPIs. This study aimed to evaluate two different doses of therapy (1 g b.i.d. vs. 1.0 g t.i.d.) and two different durations of therapy (14 vs.10 days) to gain insights of the effectiveness of Keverprazan-amoxicillin dual therapy .
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-12-12.
Trial Details
NCT Number NCT06734260
Lead Sponsor Eighth Affiliated Hospital, Sun Yat-sen University
Conditions Helicobacter Pylori Eradication Rate
Enrollment 477 participants
Start Date 2024-09-10
Primary Completion 2025-11-10 (estimated)
Study Completion 2026-01-10 (estimated)
Updated on ClinicalTrials.gov 2025-12-05