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Optimization of Keverprazan-amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection
Sponsor: Eighth Affiliated Hospital, Sun Yat-sen University
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 .
Official title: Optimization of Keverprazan-amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection:a Multicenter, Prospective, Randomized Controlled Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
477
Start Date
2024-09-10
Completion Date
2026-01-10
Last Updated
2025-12-05
Healthy Volunteers
Yes
Conditions
Interventions
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
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
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
Locations (4)
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Puning Overseas Chinese Hospital
Puning, Guangdong, China
Eighth Affiliated Hospital,Sun Yet-san University
Shenzhen, Guangdong, China
Xiangyang Hospital of Traditional Chinese Medicine
Xiangyang, Hubei, China