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.
Adult patients aged 18 to 65 years old, regardless of gender;
H. pylori positive, diagnosed a 13C-urea breath test (13C-UBT), ¹⁴C-urea breath test (¹⁴C-UBT), H&E staining or bacterial culture;
No previous history of H. pylori eradication therapy;
Subjects able to independently complete the recording of the subject diary card;
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;
Active peptic ulcer with complications such as bleeding, perforation, obstruction, canceration, etc.;
Previous history of esophageal or gastric surgery;
Severe systemic diseases, including diseases of major organs dysfunction such as (cardiac, pulmonary, cerebral), hepatic or renal impairment, malignant neoplasms , or other diseases;
Parallel
Keverprazan 10 days
DrugKeverprazan 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
DrugKeverprazan dual therapy for 14 days (K14 group): Keverprazan 20 mg, bid + Amoxicillin 1 g, tid, for 14 days.
Rabeprazole
DrugRabeprazole 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.
H. pylori eradication rate 6-8 weeks after the end of eradication treatment
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.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Through the incidence, severity (per CTCAE v5.0), and drug-drug interactions of adverse events (AEs) occurring from the start of medication until 8 weeks after the end of medication.
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