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Clinical Trials in China / NCT07122024
Recruiting Phase 4

Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment

NCT07122024 · tracked via the Priya Life Science China tracker
Sponsor
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)

Trial sites (1)

FacilityCityRegionStatus
The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

Other trials for the same condition

Official registry record

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.

View NCT07122024 on ClinicalTrials.gov ↗ ← All trials in China