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
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Adults aged 18 to 65 years, any gender
- Confirmed Helicobacter pylori infection diagnosed by 13C-urea breath test, H&E staining, or bacterial culture
- No prior history of H. pylori eradication therapy
- Able to independently complete a diary card
- Understands the trial, agrees to participate voluntarily, and can complete the study with informed consent
You will not qualify if you...
- Use of acid-suppressing drugs (PPIs, P-CAB, H2 receptor antagonists) within 2 weeks or antibiotics within 4 weeks prior to enrollment
- Active peptic ulcer with complications such as bleeding, perforation, obstruction, or cancer
- History of esophageal or gastric surgery
- Severe systemic diseases including cardiac, pulmonary, cerebral dysfunction, hepatic or renal impairment, or cancer
- Allergies or hypersensitivity to study drugs or their excipients
- Pregnant or breastfeeding females
- Long-term alcohol abuse or other conditions increasing treatment risk
- Participation in other studies within 3 months or inability to cooperate with investigators
- Any other reasons judged by the investigator as unsuitable for participation
AI-Screening
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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
CONTACT
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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