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

Launched by EIGHTH AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Dec 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach to eliminate a common stomach infection called Helicobacter Pylori (HP), which can lead to various stomach issues. The researchers are testing a combination of a medication called Keverprazan with amoxicillin, comparing two different doses and treatment durations to see which is most effective in eradicating the infection. The goal is to find a treatment that is easier to take and has fewer side effects than current options.

To participate in this study, individuals must be between 18 and 75 years old and have tested positive for HP. They should be willing to follow the study guidelines and attend all required visits. Participants will be closely monitored during the treatment to ensure their safety and to check how well the therapy works. It's important to note that some individuals, such as those who are pregnant or have certain health conditions, may not be eligible to join. If you're considering participating, you will receive more details about what to expect throughout the trial, including any necessary tests and follow-up appointments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18 to 75 years;
• • 2. Adult subjects who voluntarily signed written informed consent approved by the ethics committee to consent to participate in this study before the start of any study procedure;
• • 3. Subjects who can understand and comply with the protocol requirements and agree to attend all study visits;
• • 4. During the screening phase, patients who were Hp positive and required Hp eradication therapy as judged by the investigator, and patients who had failed Hp eradication for the first time;
• • 5. Participants agreed to use appropriate medical methods of contraception (except medically 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, nitrofuran antibiotics, or bismuth (including any relevant adjuvants). If skin sensitivity testing (skin testing) was required, it was performed at visit 1 according to routine medical practice; 4. Participants had a history of drug (including but not 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 screening visit; 5. The subjects had Zolie-Ellison syndrome, gastric acid hypersecretion, or a history of gastric acid hypersecretion; 6. The subject has undergone previous surgery or operation that may affect gastric acid secretion or drug absorption, 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, weight loss, anemia, or hematochezia that might indicate the presence of a malignant GI lesion, unless a malignant lesion was ruled out by endoscopy; 8. A history of malignancy within 5 years before screening (participants were allowed to participate if they had been cured of skin basal cell carcinoma or cervical carcinoma in situ); 9.. Upper gastrointestinal endoscopy showed acute upper gastrointestinal bleeding, active gastric or duodenal ulcer, acute gastric or duodenal mucosal injury; 10. According to the investigator's judgment, the subject has uncontrolled and unstable liver, kidney, cardiovascular, respiratory, gastrointestinal, endocrine, hematological, central nervous system or mental diseases, etc., and participating in the study may affect the safety of the subject or the interpretation of the study results; 11. Subjects who plan to be hospitalized for surgical treatment during the study; 12. H2-receptor antagonist or PPI use within 14 days prior to screening 13C-urea breath test; During the screening period, antibiotics, bismuth and some traditional Chinese medicine with antibacterial effect were taken within 28 days before 13C-urea breath test; 13. Abnormal laboratory test results at screening 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; 14. The subjects had clinically significant abnormal electrocardiogram (ECG), including severe arrhythmia, multifocal premature ventricular contractions (PVC), second degree or above atrioventricula