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

Zhang Xiaofeng,MD

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Tegoprazan 50 mg, tablets, orally, qd; Drug: Esomeprazole 20mg BID; Drug: amoxicillin 1000mg tid; Drug: Tegoprazan 50 mg, tablets, orally, bid; Drug: amoxicillin +clarithromycin+colloidal bismuth pectin BID

Study type: Interventional

Funder types: Other

Identifiers

NCT05647278

2022-184

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 370 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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370 participants in 3 patient groups

Tegoprazan 50mg QD

Experimental group

Description:

Tegoprazan 50 mg once daily plus Amoxicillin 1000mg TID for up to 2 weeks

Treatment:

Drug: amoxicillin 1000mg tid

Drug: Tegoprazan 50 mg, tablets, orally, qd

Esomeprazole 20 mg BID

Active Comparator group

Description:

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.

Treatment:

Drug: amoxicillin +clarithromycin+colloidal bismuth pectin BID

Drug: Esomeprazole 20mg BID

Tegoprazan 50 mg BID

Experimental group

Description:

Tegoprazan 50 mg twice daily plus Amoxicillin plus Amoxicillin 1000mg TID for up to 2 weeks

Treatment:

Drug: Tegoprazan 50 mg, tablets, orally, bid

Drug: amoxicillin 1000mg tid