Tegoprazan-Amoxicillin Dual Therapy vs. Bismuth Quadruple Therapy for H. Pylori Infection (TATH-1)

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-10-31

Brief Summary

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Standard eradication therapies using proton pump inhibitors (PPIs) require double doses to achieve sufficient acid suppression, yet failure rates remain high due to antibiotic resistance. Tegoprazan, a P-CAB agent, inhibits gastric acid more effectively than PPIs. This study hypothesizes that Tegoprazan-based dual therapy can achieve superior or non-inferior eradication rates compared to standard quadruple therapy. The study evaluates the antibacterial effect of Tegoprazan combined with high-dose Amoxicillin in H. pylori-infected patients.

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Detailed Description

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Note on Protocol Amendment and Registration Update: The study protocol was amended in November 2023 to include a randomized comparison of Tegoprazan 50 mg QD versus BID (within the TAT arm) and to adjust the Amoxicillin dosage to 1000 mg TID. Important Explanation: Although this amendment was approved by the Ethics Committee and implemented immediately, the update to the ClinicalTrials.gov registry was delayed due to an administrative oversight by the research team. The inclusion of the BID arm and the secondary randomization were pre-planned and executed strictly according to the protocol, not as a post-hoc analysis.

Study Description: Helicobacter pylori infection is a major cause of gastric diseases. Currently, Bismuth Quadruple Therapy (BQT) is the recommended first-line treatment in China. However, the efficacy of BQT is increasingly challenged by antibiotic resistance (especially to clarithromycin) and complex dosing regimens, which can reduce patient compliance.

Tegoprazan is a novel potassium-competitive acid blocker (P-CAB) that provides rapid, potent, and durable acid suppression, theoretically creating an ideal environment for amoxicillin to eradicate H. pylori. Unlike proton pump inhibitors (PPIs), Tegoprazan does not require activation by acid and is less influenced by CYP2C19 genetic polymorphisms.

This prospective, randomized, multicenter study aims to compare the efficacy, safety, and compliance of 14-day Tegoprazan-Amoxicillin Dual Therapy (TAT) versus Esomeprazole-based Bismuth Quadruple Therapy (BQT) in treatment-naïve patients. The study hypothesizes that the TAT regimen is superior or non-inferior to the standard BQT regimen in eradicating H. pylori infection.

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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Tegoprazan 50 mg, tablets, orally, qd

Tegoprazan 50 mg, tablets, orally, qd given in combination with amoxicillin 1000mg capsules, orally, tid for up to 2 weeks.

Intervention Type DRUG

Esomeprazole 20mg BID

esomeprazole 20 mg, tablets, orally, bid given in combination with amoxicillin 1000mg，clarithromycin 500mg bid，colloidal bismuth pectin 200mg bid for up to 2 weeks.

OR esomeprazole 20 mg, tablets, orally, bis in die given in combination with amoxicillin 750mg capsules, orally, quarter die for up to 2 weeks.

Intervention Type DRUG

Tegoprazan 50 mg, tablets, orally, bid

Tegoprazan 50 mg, tablets, orally, bid given in combination with amoxicillin 1000mg capsules, orally, tid for up to 2 weeks.

Intervention Type DRUG

amoxicillin +clarithromycin+colloidal bismuth pectin BID

amoxicillin 1000mg，clarithromycin 500mg bid，colloidal bismuth pectin 200mg bid for up to 2 weeks

Intervention Type DRUG

amoxicillin 1000mg tid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients aged ≥18 years with Hp-positive first sterilization were included in this study.
2. Before treatment, the existence of Helicobacter pylori can be confirmed by one or more of the following methods: rapid urease test, Hp culture, 13C urea breath test, 14C urea breath test and stool Hp antigen test.

Exclusion Criteria

1. acute upper gastrointestinal bleeding.
2. active gastric or duodenal ulcer.
3. acute gastric or duodenal mucosal lesions.
4. previous eradication treatment of Helicobacter pylori.
5. penicillin/furazolidone allergy.
6. surgery that may affect gastric acid secretion (upper gastrointestinal resection or vagotomy).
7. Zollinger-Ellison syndrome or other hypergastric acid secretion diseases.
8. severe neurological, cardiovascular, pulmonary, liver,renal, metabolic,gastrointestinal, urological, etc.
9. Any fertile woman must use proper contraception.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No