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

RecruitingPhase 4Ages 18 Years - 65 YearsAllSecond Affiliated Hospital, Zhejiang University, …
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Keverprazan 10 days
  • Keverprazan 14 days
  • Rabeprazole
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Where

1 site
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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