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

Phase 4RecruitingNCT07122024

Second Affiliated Hospital, Zhejiang University, School of Medicine414 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Helicobacter Pylori

Interventions

Keverprazan 10 daysDRUG

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.

Keverprazan 14 daysDRUG

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

RabeprazoleDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria 1. Adult patients aged 18 to 65 years old, regardless of gender; 2. H. pylori positive, diagnosed a 13C-urea breath test (13C-UBT), ¹⁴C-urea breath test (¹⁴C-UBT), H\&E staining or bacterial culture; 3. No previous history of H. pylori eradication therapy; 4. Subjects able to independently complete the recording of the subject diary card; 5. Subjects who fully understand the trial content, voluntarily participate in the trial, can complete the trial process, and sign the informed consent form. Exclusion Criteria 1. 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; 2. Active peptic ulcer with complications such as bleeding, perforation, obstruction, canceration, etc.; 3. Previous history of esophageal or gastric surgery; 4. Severe systemic diseases, including diseases of major organs dysfunction such as (cardiac, pulmonary, cerebral), hepatic or renal impairment, malignant neoplasms , or other diseases; 5. 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.); 6. Female participants who are pregnant, breastfeeding; 7. Long-term alcohol abuse or any other conditions that increase the risk of treatment-related adverse events; 8. Participation in other studies within the past 3 months, inability to clearly express oneself, or inability to cooperate with investigators; 9. Deemed unsuitable for participation in the study by the investigator for any other reason.

Locations (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 8-10weeks

Secondary Outcomes

Incidence of Treatment-Emergent Adverse Events (TEAEs)

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.

Time frame: From first dose of study drug until 8 weeks after last dose

Central Contacts

JUN YE

CONTACT

13858168852 wzmcyejun@zju.edu.cn

Data from ClinicalTrials.gov

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