Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment
Recruiting
Phase 4Interventional Study
Helicobacter Pylori
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
414 (estimated)
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine · Other
Who this trial is looking for
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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.
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Eligibility Criteria
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 ind…
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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