Optimizing Keverprazan and Amoxicillin Therapy for Helicobacter Pylori Eradication

Optimization of Keverprazan-amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection：a Multicenter, Prospective, Randomized Controlled Study

This study is testing a new combination of Keverprazan and different doses of amoxicillin to see if it can effectively get rid of Helicobacter Pylori infection in people.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 477 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Eighth Affiliated Hospital, Sun Yat-sen University (Academic / other)
• Locations: 4 sites (Guangzhou, Guangdong and 3 other locations)
• Trial ID: NCT06734260 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a dual therapy combining Keverprazan, a new potassium acid blocker, with varying doses of amoxicillin to eradicate Helicobacter Pylori infection. The study aims to compare the eradication rates of two different dosing regimens over a treatment period of 10 days. By utilizing Keverprazan, which offers a stronger and longer-lasting acid suppression compared to traditional proton pump inhibitors, the trial seeks to improve patient compliance and reduce adverse reactions associated with current treatment regimens. Participants will be closely monitored to assess the efficacy and safety of the treatment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 who are Helicobacter Pylori positive and require eradication therapy.

Not a fit: Patients who are pregnant, lactating, or have known allergies to the study medications will not benefit from this trial.

Why it matters

Potential benefit: If successful, this therapy could provide a more effective and safer option for eradicating Helicobacter Pylori, potentially reducing related health complications.

How similar studies have performed: While the use of Keverprazan is relatively novel, previous studies have shown promising results with similar approaches in Helicobacter Pylori eradication.

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

Where this trial is running

Guangzhou, Guangdong and 3 other locations

• The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• Puning Overseas Chinese Hospital — Puning, Guangdong, China (Recruiting)
• Eighth Affiliated Hospital,Sun Yet-san University — Shenzhen, Guangdong, China (Recruiting)
• Xiangyang Hospital of Traditional Chinese Medicine — Xiangyang, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Honglei Chen, MD

Conditions Helicobacter Pylori Eradication Rate