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

Not Applicable

Recruiting

• Conditions: Helicobacter Pylori Eradication
• Interventions: Drug: vonoprazan, amoxicillin; Drug: vonoprazan, amoxicillin, tripotassium dicitrate bismuthate; Drug: rabeprazole, amoxicillin, clarithromycin

• Registration Number: NCT06349486
• Lead Sponsor: Kaohsiung Medical University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-11-28
• Status Verified: 2024-04
• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Study First Posted: 2024-04-05
• Last Update Posted: 2024-04-05
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 780

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vonoprazan-amoxicillin dual therapy	vonoprazan, amoxicillin	vonoprazan 20mg twice a day + amoxicillin 750mg，Four times a day
bismuth-amoxicillin-vonoprazan triple therapy	vonoprazan, amoxicillin, tripotassium dicitrate bismuthate	vonoprazan 20mg twice a day + amoxicillin 750mg four times a day + tripotassium dicitrate bismuthate 300mg four times a day
proton pump inhibitor-based standard triple therapy	rabeprazole, amoxicillin, clarithromycin	rabeprazole 20mg twice a day + amoxicillin 1gm twice a day + clarithromycin 500mg twice a day

Primary Outcome Measures

Name	Time	Method
the eradication rate of Helicobacter pylori	8 week after finishing study drugs	evalute eradication outcome by 13C urea breath test

Secondary Outcome Measures

Name	Time	Method
genotype analysis	1 day	CYP3A4, CYP2C19 and IL-1B -511 genotypes

Trial Locations

Locations (1)

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan