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RECRUITING
NCT06734260
PHASE3

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

Sponsor: Eighth Affiliated Hospital, Sun Yat-sen University

View on ClinicalTrials.gov

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

Interventions

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

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