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

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

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

Sponsors & Collaborators

• Eighth Affiliated Hospital, Sun Yat-sen University

  lead OTHER

Principal Investigators

• Shanshan Wei, MD · The Eighth Affiliated Hospital,sun Yet-san University

• Huizhen Xiong · The Eighth Affiliated Hospital,sun Yet-san University

• Meifang Ye · The Eighth Affiliated Hospital,sun Yet-san University

• Jianfeng Zhong · The Eighth Affiliated Hospital,sun Yet-san University

• Wei Liu · The Eighth Affiliated Hospital,sun Yet-san University

• Fang Liu · The Eighth Affiliated Hospital,sun Yet-san University

• Ting Zhou · The Eighth Affiliated Hospital,sun Yet-san University

• Qiucheng Li · The Eighth Affiliated Hospital,sun Yet-san University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-09-10

Primary Completion

2025-11-10

Completion

2026-01-10

Countries

• China

Study Locations