Actively Recruiting
Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-08-14
414
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Keverprazan-amoxicillin dual therapy compared to Rabeprazole quadruple therapy for treating Helicobacter pylori infection. This open-label, randomized controlled study plans to enroll 414 adults aged 18 to 65 years who have tested positive for H. pylori and have not received prior eradication therapy. Participants will be randomly assigned to one of three groups to compare different treatment durations and regimens. The study includes three treatment groups: one receiving Keverprazan 20 mg twice daily plus Amoxicillin 1 g three times daily for 10 days, another receiving the same dual therapy for 14 days, and a control group receiving Rabeprazole 10 mg, Amoxicillin 1 g, Clarithromycin 500 mg, and colloidal pectin bismuth 200 mg twice daily for 14 days. Participants will be randomized equally into these groups and followed over the course of their assigned treatment. Participants will attend a screening visit to provide consent, medical history, and baseline information, including tests for H. pylori. Follow-up includes a telephone visit during treatment to check vital signs, medication use, and any side effects. A final visit 9 weeks after treatment completion will include physical exams and repeat H. pylori testing to assess eradication. Researchers will monitor adverse events and treatment adherence throughout the study, with the primary goal of measuring H. pylori eradication 6 to 8 weeks after treatment ends.
CONDITIONS
Brief Title
Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 to 65 years old, regardless of gender
- Confirmed Helicobacter pylori infection diagnosed by 13C-urea breath test, 14C-urea breath test, H&E staining, or bacterial culture
- No previous history of H. pylori eradication therapy
- Ability to independently complete a subject diary card
- Understands the trial and voluntarily agrees to participate and complete the study process with signed informed consent
You will not qualify if you...
- Use of acid-suppressing drugs (PPIs, P-CAB, H2 receptor antagonists) within 2 weeks before enrollment or antibiotics within 4 weeks before enrollment
- Active peptic ulcer with complications such as bleeding, perforation, obstruction, or canceration
- History of esophageal or gastric surgery
- Severe systemic diseases, including major organ dysfunction, liver or kidney impairment, or malignant tumors
- Allergies or hypersensitivity to study drugs or their excipients
- Pregnant or breastfeeding women
- Long-term alcohol abuse or other conditions increasing treatment risk
- Participation in other studies within past 3 months or inability to cooperate with investigators
- Considered unsuitable for study participation by the investigator for any other reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 to 14 days
Participants receive assigned drug therapy for Helicobacter pylori infection, either Keverprazan dual therapy for 10 days, Keverprazan dual therapy for 14 days, or Rabeprazole quadruple therapy for 14 days.
1 visit (in-person) and 1 telephone visit during treatment
Duration - Approximately 9 weeks
Participants are monitored for safety and Helicobacter pylori eradication after completing treatment.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
J
JUN YE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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