NCT07122024

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 414 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Study duration: Starting from the date of ethics approval and clinical registration completion, the project will last for 1 year. If you agree to participate in this study, you will be assigned to one of the three treatment groups through randomization (with a 33% probability for each group), with 138 subjects in each group. The study is divided into a screening phase and a treatment phase, with a total of 4 visit points: Screening period: -7 to 0 days 1. Obtain informed consent; 2. Collect demographic information and baseline characteristics of the subject; 3. Record medical history and current treatment, concomitant medications (including prescription and over-the-counter drugs); 4. Vital signs, physical examination; 5. H. pylori test; 6. Review inclusion and exclusion criteria; 7. Eligible subjects will be randomized to receive assigned treatment based on randomization numbers. Visit period V2 (telephone visit): K10 group: 10 days (±3 days), K14 group: 14 days (±3 days), R14 group: 14 days (±3 days) 1. Vital signs, physical examination; 2. Record concomitant medications; 3. Record adverse events after medication. Visit period V3: 9 weeks (±7 days) 1\) Vital signs, physical examination; 2) H. pylori test; 3) Record concomitant medications; 4) Record adverse events after medication.

Conditions

• Helicobacter Pylori

Interventions

Type	Name	Description
DRUG	Keverprazan 10 days	Keverprazan dual therapy for 10 days (K10 group): Keverprazan 20 mg per dose, twice daily (bid) + Amoxicillin 1 g per dose, three times (tid) daily, for 10 days.
DRUG	Keverprazan 14 days	Keverprazan dual therapy for 14 days (K14 group): Keverprazan 20 mg, bid + Amoxicillin 1 g, tid, for 14 days.
DRUG	Rabeprazole	Rabeprazole quadruple therapy for 14 days (R14 group): Rabeprazole sodium 10 mg + Amoxicillin 1 g + Clarithromycin 500 mg + Colloidal pectin bismuth 200 mg, bid, for 14 days.

Timeline

• Start date: 2024-02-19
• Primary completion: 2025-08-31
• Completion: 2025-12-30
• First posted: 2025-08-14
• Last updated: 2025-08-14

Locations

1 site across 1 country: China