NCT06734260

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

Optimization of Keverprazan-amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection：a Multicenter, Prospective, Randomized Controlled Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 477 (estimated)
• Sponsor: Eighth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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 .

Conditions

• Helicobacter Pylori Eradication Rate

Interventions

Type	Name	Description
DRUG	Keverprazan Hydrochloride tablets + high dose amoxicillin	Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral Amoxicillin 1000mg/ time, 3 times/day, oral, for 14 day
DRUG	Keverprazan Hydrochloride tablets + low dose amoxicillin	Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral Amoxicillin 1000mg/ time, 2 times/day, oral, for 14 day
DRUG	Keverprazan Hydrochloride tablets + high dose amoxicillin（H-KA-10d）	Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral Amoxicillin 1000mg/ time, 3 times/day, oral, for 10 day

Timeline

• Start date: 2024-09-10
• Primary completion: 2025-11-10
• Completion: 2026-01-10
• First posted: 2024-12-16
• Last updated: 2025-12-05

Locations

4 sites across 1 country: China