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

Kaohsiung Medical University

Status: Enrolling

Conditions: Helicobacter Pylori Eradication

Treatments: Drug: vonoprazan, amoxicillin, tripotassium dicitrate bismuthate; Drug: vonoprazan, amoxicillin; Drug: rabeprazole, amoxicillin, clarithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT06349486

KMUHIRB-F(II)-20230179

Details and patient eligibility

About

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.

Full 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.

Enrollment: 390 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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390 participants in 3 patient groups

bismuth-amoxicillin-vonoprazan triple therapy

Active Comparator group

Description:

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

Treatment:

Drug: vonoprazan, amoxicillin, tripotassium dicitrate bismuthate

vonoprazan-amoxicillin dual therapy

Active Comparator group

Description:

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

Treatment:

Drug: vonoprazan, amoxicillin

proton pump inhibitor-based standard triple therapy

Active Comparator group

Description:

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

Treatment:

Drug: rabeprazole, amoxicillin, clarithromycin