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

NCT07122024 | Recruiting Phase 4

• 2 other identifiers: Keverprazan Helicobacter pyloFK2024-6926
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori

Outcome Measures

Primary Outcomes (1)

• H. pylori eradication rate 6-8 weeks after the end of eradication treatment

  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.

  8-10weeks

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  From first dose of study drug until 8 weeks after last dose

Study Arms (3)

Keverprazan Dual Therapy for 10 Days

EXPERIMENTAL

Keverprazan 20 mg per dose, twice daily (bid) + Amoxicillin 1 g per dose, three times (tid) daily, for 10 days.

Drug: Keverprazan 10 days

Keverprazan Dual Therapy for 14 Days

ACTIVE COMPARATOR

Keverprazan 20 mg, bid + Amoxicillin 1 g, tid, for 14 days.

Drug: Keverprazan 14 days

Rabeprazole Quadruple Therapy for 14 Days

ACTIVE COMPARATOR

Rabeprazole sodium 10 mg + Amoxicillin 1 g + Clarithromycin 500 mg + Colloidal pectin bismuth 200 mg, bid, for 14 days.

Drug: Rabeprazole

Interventions

Keverprazan 10 days DRUG

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.

Also known as: Amoxicillin

Keverprazan Dual Therapy for 10 Days

Keverprazan 14 days DRUG

Keverprazan dual therapy for 14 days (K14 group): Keverprazan 20 mg, bid + Amoxicillin 1 g, tid, for 14 days.

Also known as: Amoxicillin

Keverprazan Dual Therapy for 14 Days

Rabeprazole DRUG

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.

Also known as: Amoxicillin Clarithromycin Colloidal pectin bismuth

Rabeprazole Quadruple Therapy for 14 Days

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Subjects who fully understand the trial content, voluntarily participate in the trial, can complete the trial process, and sign the informed consent form.

You may not qualify if:

• 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;
• Participants with allergies or hypersensitivity to keverprazan, rabeprazole, amoxicillin, clarithromycin, bismuth agents, including its excipients (such as mannitol, microcrystalline cellulose, crospovidone, hypromellose, magnesium stearate, etc.);
• Female participants who are pregnant, breastfeeding;
• Long-term alcohol abuse or any other conditions that increase the risk of treatment-related adverse events;
• Participation in other studies within the past 3 months, inability to clearly express oneself, or inability to cooperate with investigators;
• Deemed unsuitable for participation in the study by the investigator for any other reason.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Interventions

Amoxicillin; Rabeprazole

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Study Officials

• QIN DU

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

• JUN YE

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JUN YE

CONTACT

13858168852; wzmcyejun@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Treatment

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: August 14, 2025
• Study Start: February 19, 2024
• Primary Completion: August 31, 2025
• Study Completion: December 30, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2025.12
• Access Criteria: Authorization from the PrincipalInvestigator (Pl) of this study is required

Locations

CN (1)