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

Not Applicable

Recruiting

• Conditions: Helicobacter Pylori
• Interventions: Drug: Keverprazan 10 days; Drug: Keverprazan 14 days; Drug: Rabeprazole

• Registration Number: NCT07122024
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Study Timeline

• Study Start: 2024-02-19
• Study First Submitted: 2025-06-03
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-09
• Last Update Submitted: 2025-08-09
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 414

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Keverprazan Dual Therapy for 10 Days	Keverprazan 10 days	Keverprazan 20 mg per dose, twice daily (bid) + Amoxicillin 1 g per dose, three times (tid) daily, for 10 days.
Keverprazan Dual Therapy for 14 Days	Keverprazan 14 days	Keverprazan 20 mg, bid + Amoxicillin 1 g, tid, for 14 days.
Rabeprazole Quadruple Therapy for 14 Days	Rabeprazole	Rabeprazole sodium 10 mg + Amoxicillin 1 g + Clarithromycin 500 mg + Colloidal pectin bismuth 200 mg, bid, for 14 days.

Primary Outcome Measures

Name	Time	Method
H. pylori eradication rate 6-8 weeks after the end of eradication treatment	8-10weeks	Efficacy Endpoints: The primary efficacy endpoint is the proportion of subjects achieving successful Helicobacter pylori eradication 6-8 weeks after completion of first-line therapy. Eradication rates will be reported with two-sided 95% confidence intervals (CIs) calculated using the Clopper-Pearson method. Inter-group differences will be estimated along with their 95% CIs using the Miettinen-Nurminen method. Inter-group comparisons will be performed using the chi-square test or Fisher's exact test, as appropriate.

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events (TEAEs)	From first dose of study drug until 8 weeks after last dose	Through the incidence, severity (per CTCAE v5.0), and drug-drug interactions of adverse events (AEs) occurring from the start of medication until 8 weeks after the end of medication.

Trial Locations

Locations (1)

The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China