Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

Qualifiers

Adult patients aged 18 to 65 years old, regardless of gender;

H. pylori positive, diagnosed a 13C-urea breath test (13C-UBT), ¹⁴C-urea breath test (¹⁴C-UBT), H&E staining or bacterial culture;

No previous history of H. pylori eradication therapy;

Subjects able to independently complete the recording of the subject diary card;

Disqualifiers

Use of acid-suppressing drugs such as proton pump inhibitors (PPIs), potassium-competitive acid blocker (P-CAB), H2 receptor antagonists, etc., within 2 weeks before enrollment, or use of antibiotics within 4 weeks before enrollment;

Active peptic ulcer with complications such as bleeding, perforation, obstruction, canceration, etc.;

Previous history of esophageal or gastric surgery;

Severe systemic diseases, including diseases of major organs dysfunction such as (cardiac, pulmonary, cerebral), hepatic or renal impairment, malignant neoplasms , or other diseases;

Trial design

Treatments tested in this trial

  • Keverprazan 10 days
  • Keverprazan 14 days
  • Rabeprazole

Treatment groups

414 Participants
are divided into 3 treatment groups