Optimization of Keverprazan-amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection

Inclusion Criteria:

1. Aged 18 to 75 years;

2. Adult subjects who voluntarily signed written informed consent approved by theethics committee to consent to participate in this study before the start of anystudy procedure;

3. Subjects who can understand and comply with the protocol requirements and agree toattend all study visits;

4. During the screening phase, patients who were Hp positive and required Hperadication therapy as judged by the investigator, and patients who had failed Hperadication for the first time;

5. Participants agreed to use appropriate medical methods of contraception (exceptmedically sterilized status) during the study.

Exclusion Criteria:

1. Participated in other clinical studies within 4 weeks before screening; 2.Pregnant or lactating women; 3. Known allergy to keverprazan, esomeprazole,penicillins or other beta-lactams, macrolide antibiotics, nitrofuranantibiotics, or bismuth (including any relevant adjuvants). If skin sensitivitytesting (skin testing) was required, it was performed at visit 1 according toroutine medical practice; 4. Participants had a history of drug (including butnot limited to opioids) abuse or alcohol abuse (> 14 units of alcohol per week, 1 unit of alcohol ≈360mL of approximately 5% beer or 45 ml of approximately 40%spirits or 150 ml of approximately 12% wine) in the year before the screeningvisit; 5. The subjects had Zolie-Ellison syndrome, gastric acid hypersecretion,or a history of gastric acid hypersecretion; 6. The subject has undergoneprevious surgery or operation that may affect gastric acid secretion or drugabsorption, such as subtotal gastrectomy, total gastrectomy, vagotomy,intestinal resection, etc. Simple surgery for perforation, appendectomy,cholecystectomy, and endoscopic resection of benign tumors are acceptable; 7. "Warning" symptoms such as odynophagia, severe dysphagia, bleeding, weightloss, anemia, or hematochezia that might indicate the presence of a malignantGI lesion, unless a malignant lesion was ruled out by endoscopy; 8. A historyof malignancy within 5 years before screening (participants were allowed toparticipate if they had been cured of skin basal cell carcinoma or cervicalcarcinoma in situ); 9.. Upper gastrointestinal endoscopy showed acute uppergastrointestinal bleeding, active gastric or duodenal ulcer, acute gastric orduodenal mucosal injury; 10. According to the investigator's judgment, thesubject has uncontrolled and unstable liver, kidney, cardiovascular,respiratory, gastrointestinal, endocrine, hematological, central nervous systemor mental diseases, etc., and participating in the study may affect the safetyof the subject or the interpretation of the study results; 11. Subjects whoplan to be hospitalized for surgical treatment during the study; 12.H2-receptor antagonist or PPI use within 14 days prior to screening 13C-ureabreath test; During the screening period, antibiotics, bismuth and sometraditional Chinese medicine with antibacterial effect were taken within 28days before 13C-urea breath test; 13. Abnormal laboratory test results atscreening in any of the following: AST > upper limit of normal (ULN); ALT >Upper limit of normal (ULN); Total bilirubin > ULN; creatinine > 1.5 times ULN;
2. The subjects had clinically significant abnormal electrocardiogram (ECG),including severe arrhythmia, multifocal premature ventricular contractions (PVC), second degree or above atrioventricula