Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Phase 4
Started
2024-02-19
Last updated
2025-08-14
Condition(s) studied
Helicobacter Pylori
Investigational drug(s) / intervention(s)
Keverprazan 10 daysKeverprazan 14 daysRabeprazole
Keverprazan 10 days: Keverprazan dual therapy for 10 days (K10 group):
Keverprazan 20 mg per dose, twice daily (bid) + Amoxicillin 1 g per dose, three times (tid) daily, for 10 days.
Keverprazan 14 days: Keverprazan dual therapy for 14 days (K14 group): Keverprazan 20 mg, bid + Amoxicillin 1 g, tid, for 14 days.
Rabeprazole: Rabeprazole quadruple therapy for 14 days (R14 group): Rabeprazole sodium 10 mg + Amoxicillin 1 g + Clarithromycin 500 mg + Colloidal pectin bismuth 200 mg, bid, for 14 days.
Study summary
This is an open-label, randomized controlled study. The study plans to enroll 414 subjects with Helicobacter pylori infection, who will be randomly assigned to the experimental group (Keverprazan dual therapy for 10 days or Keverprazan dual therapy for 14 days) or the control group (Rabeprazole quadruple therapy for 14 days) at a ratio of 1:1:1.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria
1. Adult patients aged 18 to 65 years old, regardless of gender;
2. H. pylori positive, diagnosed a 13C-urea breath test (13C-UBT), ¹⁴C-urea breath test (¹⁴C-UBT), H\&E staining or bacterial culture;
3. No previous history of H. pylori eradication therapy;
4. Subjects able to independently complete the recording of the subject diary card;
5. Subjects who fully understand the trial content, voluntarily participate in the trial, can complete the trial process, and sign the informed consent form.
Exclusion Criteria
1. Use of acid-suppressing drugs such as proton pump inhibitors (PPIs), potassium-competitive acid blocker (P-CAB), H2 receptor antagonists, etc., within 2 weeks before enrollment, or use of antibiotics within 4 weeks before enrollment;
2. Active peptic ulcer with complications such as bleeding, perforation, obstruction, canceration, etc.;
3. Previous history of esophageal or gastric surgery;
4. Severe systemic diseases, including diseases of major organs dysfunction such as (cardiac, pulmonary, cerebral), hepatic or renal impairment, malignant neoplasms , or other diseases;
5. Participants with allergies or hypersensitivity to keverprazan, rabeprazole, amoxicillin, clarithromycin, bismuth agents, including its excipients (such as mannitol, microcrystalline cellulose, crospovidone, hypromellose, magnesium stearate, etc.);
6. Female participants who are pregnant, breastfeeding;
7. Long-term alcohol abuse or any other conditions that increase the risk of treatment-related adverse events;
8. Participation in other studies within the past 3 months, inability to clearly express oneself, or inability to cooperate with investigators;
9. Deemed unsuitable for participation in the study by the investigator for any other reason.
Primary outcome measure(s)
H. pylori eradication rate 6-8 weeks after the end of eradication treatment — 8-10weeks Efficacy Endpoints:
The primary efficacy endpoint is the proportion of subjects achieving successful Helicobacter pylori eradication 6-8 weeks after completion of first-line therapy. Eradication rates will be reported with two-sided 95% confidence intervals (CIs) calculated using the Clopper-Pearson method. Inter-group differences will be estimated along with their 95% CIs using the Miettinen-Nurminen method. Inter-group comparisons will be performed using the chi-square test or Fisher's exact test, as appropriate.
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
Zhejiang
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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