Actively Recruiting
Optimization of Keverprazan-amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection
Led by Eighth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-12-05
477
Participants Needed
4
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Optimization of Keverprazan-amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years
- Signed informed consent approved by the ethics committee
- Able to understand and follow study requirements and attend all visits
- Tested positive for Helicobacter pylori and require eradication therapy or have failed first eradication treatment
- Agree to use appropriate contraception during the study if applicable
You will not qualify if you...
- Participated in other clinical studies within 4 weeks before screening
- Pregnant or lactating women
- Known allergy to keverprazan, esomeprazole, penicillins, macrolide antibiotics, nitrofuran antibiotics, or bismuth
- History of drug or alcohol abuse exceeding specified limits in the past year
- History or presence of Zollinger-Ellison syndrome or gastric acid hypersecretion
- Previous surgery affecting gastric acid secretion or drug absorption (except minor surgeries)
- Symptoms indicating possible malignant gastrointestinal lesions unless ruled out by endoscopy
- History of malignancy within 5 years (except cured skin basal cell carcinoma or cervical carcinoma in situ)
- Acute upper gastrointestinal bleeding, active ulcer, or mucosal injury seen on endoscopy
- Uncontrolled or unstable major organ diseases that may affect safety or study results
- Planned hospitalization for surgery during the study
- Use of H2-receptor antagonists or PPIs within 14 days before screening
- Use of antibiotics, bismuth, or antibacterial traditional Chinese medicines within 28 days before screening
- Abnormal laboratory test results exceeding defined limits
- Clinically significant abnormal electrocardiogram including severe arrhythmia or significant conduction issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
2
Puning Overseas Chinese Hospital
Puning, Guangdong, China, 515300
Actively Recruiting
3
Eighth Affiliated Hospital,Sun Yet-san University
Shenzhen, Guangdong, China, 518033
Actively Recruiting
4
Xiangyang Hospital of Traditional Chinese Medicine
Xiangyang, Hubei, China, 441000
Actively Recruiting
Research Team
H
Honglei Chen, MD
CONTACT
S
Shanshan Wei, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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