Comparison of Vonoprazan-based Versus Lansoprazole-based Triple Therapy, High Dose Dual Therapy, Bismuth and Non-bismuth Quadruple Therapy in the First-line Treatment of Helicobacter Pylori Infection

NCT04713670 | Recruiting Phase 4

• 1 other identifier: 202004063MINA
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Bismuth quadruple therapy is currently the recommended first-line regimen for Helicobacter pylori (H. pylori) infection in regions with high clarithromycin resistance. Recent randomized trials showed that 7-day vonoprazan-based triple therapy is superior to 7-day lansoprazole-based triple therapy in Japanese. A recent trial further showed that 7-day vonoprazan-based high dose amoxicillin dual therapy was non-inferior to 7-day vonoprazan-based triple therapy in Japanese. However, whether vonoprazan based dual, triple, and quadruple therapies are superior or non-inferior to lansoprazole based triple or quadruple therapy remains unknown. Objective: The investigators aimed to compare the efficacy and safety of 14-day vonoprazan-based dual therapy, triple therapy, bismuth quadruple therapy, reverse hybrid therapy, and lansoprazole-based bismuth quadruple therapy and triple therapy in the first-line treatment of H. pylori infection in this pilot study. Methods: Using a block randomization with a block size of 16 in a 1:1 ratio, 1200 eligible adult subjects aged 20 years or greater with at least two positive tests for H. pylori infection will be randomized to receive one of the following regimens: (A) vonoprazan-based triple therapy for 14 days (T-V14): vonoprazan 20mg twice daily, clarithromycin-XL 500mg twice daily, amoxicillin 1000mg twice daily for 14 days ; or (B) vonoprazan-based triple therapy for 7 days (T-V7): vonoprazan 20mg twice daily, clarithromycin-XL 500mg twice daily, amoxicillin 1000mg twice daily for 7 days ; or (C): vonoprazan-based dual therapy for 14 days (D-V14): vonoprazan 20mg twice daily, amoxicillin 750mg every 8 hour for 14 days; (D): vonoprazan-based high dose dual therapy for 14 days (HD-V14): vonoprazan 20mg twice daily, amoxicillin 750mg four times a day for 14 days; or (E) vonoprazan-based bismuth quadruple therapy for 14 days (BQ-V14) vonoprazan 20mg twice daily, bismuth tripotassium dicitrate 300 mg three times a day, tetracycline 500mg three times a day, and metronidazole 500mg three times a day for 14 days; or (F) vonoprazan-based reverse hybrid therapy for 14 days (RH-V14): vonoprazan 20mg twice daily, and amoxicillin 1000mg twice daily for 14 days, plus clarithromycin-XL 500mg twice daily and metronidazole 500mg twice daily for the first 7 days ; or (G) lansoprazole-based bismuth quadruple therapy for 14 days (BQ-L14) lansoprazole 30mg twice daily, bismuth tripotassium dicitrate 300 mg three times a day, tetracycline 500mg three times a day, and metronidazole 500mg three times a day for 14 days; or (H) lansoprazole-based triple therapy for 14 days (T-L14): lansoprazole 30mg twice daily, clarithromycin-XL 500mg twice daily, amoxicillin 1000mg twice daily for 14 days. Subjects who fail after first-line therapy will be randomized to receive either vonoprazan-based levofloxacin triple therapy (LT-V14) containing vonoprazan 20mg twice daily, levofloxacin 250mg twice daily, and amoxicillin 1000mg twice daily for 14 days or vonoprazan-based levofloxacin reverse hybrid therapy (LRH-V14) containing vonoprazan 20mg twice daily, and amoxicillin 1000mg twice daily for 14 days, plus levofloxacin 250mg twice daily and metronidazole 500mg twice daily for the first 7 days. The minimum inhibitory concentrations will be determined by agar dilution test. 23S ribosomal RNA and gyrase A mutations will be determined by PCR methods followed by direct sequencing in a subgroup of patients. The TWB2.0 SNP array will be used for genotyping of genome wide single nucleotide polymorphism. Outcome analysis: The primary outcome is the eradication rate in the first-line treatment. The secondary outcomes are the compliance, frequency of adverse events, the overall eradication rate after two treatments.

Conditions

H. Pylori Infection

Keywords

H.pylori; vonoprazan; lansoprazole; triple therapy; high dose dual therapy; bismuth quadruple

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the eradication rate in the first-line treatment.

  At least 6 weeks after the end of treatment, the carbon 13-breath test will be used to evaluate whether the eradication is successful. The eradication rate in each group will be presented as "%"

  Up to 8-12 weeks

Secondary Outcomes (1)

• The secondary outcomes are the compliance and frequency of adverse events.

  Up to 8-12 weeks

Study Arms (8)

(A) T-V14

EXPERIMENTAL

Drug: (A) T-V14

(B) T-V7

EXPERIMENTAL

Drug: (B) T-V7

(C) D-V14

EXPERIMENTAL

Drug: (C) D-V14

(D) HD-V14

EXPERIMENTAL

Drug: (D) HD-V14

(E) BQ-V14

EXPERIMENTAL

Drug: (E) BQ-V14

(F) RH-V14

EXPERIMENTAL

Drug: (F) RH-V14

(G) BQ-L14

EXPERIMENTAL

Drug: (G) BQ-L14

(H) T-L14

EXPERIMENTAL

Drug: (H) T-L14

Interventions

(A) T-V14 DRUG

vonoprazan(vocinti)-based triple therapy for 14 days (T-V14)

(A) T-V14

(B) T-V7 DRUG

vonoprazan(vocinti)-based triple therapy for 7 days (T-V7)

(B) T-V7

(C) D-V14 DRUG

vonoprazan(vocinti)-based dual therapy for 14 days (D-V14)

(C) D-V14

(D) HD-V14 DRUG

vonoprazan(vocinti)-based high dose dual therapy for 14 days (HD-V14)

(D) HD-V14

(E) BQ-V14 DRUG

vonoprazan(vocinti)-based bismuth quadruple therapy for 14 days (BQ-V14)

(E) BQ-V14

(F) RH-V14 DRUG

vonoprazan(vocinti)-based reverse hybrid therapy for 14 days (RH-V14)

(F) RH-V14

(G) BQ-L14 DRUG

lansoprazole(takepron)-based bismuth quadruple therapy for 14 days (BQ-L14)

(G) BQ-L14

(H) T-L14 DRUG

lansoprazole(takepron)-based triple therapy for 14 days (T-L14)

(H) T-L14

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with naive H. pylori infection
• Subjects with over 20 years old

You may not qualify if:

• Younger than 20 years old
• Ever received H. eradication therapy
• ever received total or subtotal gastrectomy in the past
• Severe chronic disease, such as end stage renal disease, liver cirrhosis, incurable malignant tumors
• Women who are pregnant or breastfeeding
• Those who are not suitable to receive study drugs: such as a history of allergies to study drugs or serious side effects, etc.
• Patients with chronic hepatitis (AST or ALT \>40 IU/L)
• Subjects who cannot sign informed consent by themselves

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Interventions

Fumigant 93; Protons

Intervention Hierarchy (Ancestors)

Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Jyh-Ming Liou, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei-Jyh Chen, MD

CONTACT

88623123456; migichen@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: January 19, 2021
• Study Start: March 10, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

TW (1)