Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy for Hp Eradication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-28

Study Completion Date

2026-12-31

Brief Summary

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1. Compare the efficacies and safety of 14-day bismuth-amoxicillin-vonoprazan tiple therapy, 14-day vonoprazan dual therapy and 14-day rabeprazole triple therapy in the first-line treatment of H. pylori infection.
2. To investigate the impacts of antibiotic resistance of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H. pylori treatments.

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Detailed Description

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For this multi-center, randomized, open-label, superiority trial, we will recruit 780 adult patients with H. pylori infection from ten medical centers or regional hospitals in Taiwan. Using a computer generated randomized sequence, we randomly allocate patients (1:1:1; block size of six) to either 14-day bismuth-amoxicillin-vonoprazan triple therapy, 14-day vonoprazan dual therapy, or 14-day rabeprazole-triple therapy. Patients are asked to return at the second week to assess drug adherence and adverse events. Post-treatment H. pylori status is assessed by 13C-urea breath test at week 6. Participants with failure of H. pylori eradication will randomly receive either 14-day vonoprazan-based or 14-day esomeprazole-based bismuth quadruple therapy. Finally, the rates of eradication and adverse events will be compared between groups by chi-square test. Additionally, the effects of antibiotic resistances of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of above first-line and second-line anti-H. pylori treatments are assessed by multivariate analysis.

Conditions

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Helicobacter Pylori Eradication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. bismuth-amoxicillin-vonoprazan triple therapy
2. vonoprazan-amoxicillin dual therapy
3. proton pump inhibitor-based standard triple therapy

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bismuth-amoxicillin-vonoprazan triple therapy

vonoprazan 20mg twice a day + amoxicillin 750mg four times a day + tripotassium dicitrate bismuthate 300mg four times a day

Group Type ACTIVE_COMPARATOR

vonoprazan, amoxicillin, tripotassium dicitrate bismuthate

Intervention Type DRUG

bismuth-amoxicillin-vonoprazan triple therapy

vonoprazan-amoxicillin dual therapy

vonoprazan 20mg twice a day + amoxicillin 750mg，Four times a day

Group Type ACTIVE_COMPARATOR

vonoprazan, amoxicillin

Intervention Type DRUG

vonoprazan-amoxicillin dual therapy

proton pump inhibitor-based standard triple therapy

rabeprazole 20mg twice a day + amoxicillin 1gm twice a day + clarithromycin 500mg twice a day

Group Type ACTIVE_COMPARATOR

rabeprazole, amoxicillin, clarithromycin

Intervention Type DRUG

proton pump inhibitor-based standard triple therapy

Interventions

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rabeprazole, amoxicillin, clarithromycin

proton pump inhibitor-based standard triple therapy

Intervention Type DRUG

vonoprazan, amoxicillin, tripotassium dicitrate bismuthate

bismuth-amoxicillin-vonoprazan triple therapy

Intervention Type DRUG

vonoprazan, amoxicillin

vonoprazan-amoxicillin dual therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

(1) At least 18 years old. (2) Subjects infected with Helicobacter pylori.

Exclusion Criteria

1. Those who have ever received Helicobacter pylori sterilization treatment.
2. Those who are allergic to the drugs used in this research.
3. Those who have had stomach surgery.
4. Those with severe liver cirrhosis or uremia or malignant tumors.
5. Women who are pregnant or breastfeeding.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No