Helicobacter Pylori InfectionPhase 4TATH-1NCT05647278
Tegoprazan-Amoxicillin Dual Therapy vs. Bismuth Quadruple Therapy for H. Pylori Infection (TATH-1)
A Phase 4 study testing Tegoprazan 50 mg, tablets, orally, qd, Esomeprazole 20mg BID and Tegoprazan 50 mg, tablets, orally, bid in people with Helicobacter Pylori Infection, run by Zhang Xiaofeng,MD at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Tegoprazan 50 mg, tablets, orally, qd, Esomeprazole 20mg BID and Tegoprazan 50 mg, tablets, orally, bid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 31 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years with Hp-positive first sterilization were included in this study.
- 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.
Who cannot join
- acute upper gastrointestinal bleeding.
- active gastric or duodenal ulcer.
- acute gastric or duodenal mucosal lesions.
- previous eradication treatment of Helicobacter pylori.
- penicillin/furazolidone allergy.
- surgery that may affect gastric acid secretion (upper gastrointestinal resection or vagotomy).
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- Zollinger-Ellison syndrome or other hypergastric acid secretion diseases.
- severe neurological, cardiovascular, pulmonary, liver,renal, metabolic,gastrointestinal, urological, etc.
- Any fertile woman must use proper contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tegoprazan-Amoxicillin Dual Therapy Versus Esomeprazole-Based Bismuth Quadruple Therapy for First-Line Helicobacter Pylori Eradication: A Prospective, Randomized, Multicenter, Superiority Study (TATH-1)
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.
Read the detailed 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.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Tegoprazan 50 mg, tablets, orally, qd, Esomeprazole 20mg BID, Tegoprazan 50 mg, tablets, orally, bid, amoxicillin +clarithromycin+colloidal bismuth pectin BID, amoxicillin 1000mg tid
- Keywords
- Helicobacter pylori, Eradication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegoprazan 50 mg, tablets, orally, qdDrug
Tegoprazan 50 mg, tablets, orally, qd given in combination with amoxicillin 1000mg capsules, orally, tid for up to 2 weeks.
Esomeprazole 20mg BIDDrug
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.
Tegoprazan 50 mg, tablets, orally, bidDrug
Tegoprazan 50 mg, tablets, orally, bid given in combination with amoxicillin 1000mg capsules, orally, tid for up to 2 weeks.
amoxicillin +clarithromycin+colloidal bismuth pectin BIDDrug
amoxicillin 1000mg，clarithromycin 500mg bid，colloidal bismuth pectin 200mg bid for up to 2 weeks
amoxicillin 1000mg tidDrug
amoxicillin 1000mg tid
| Study group | Role | What they receive |
|---|---|---|
| Tegoprazan 50mg QD | Experimental | Tegoprazan 50 mg once daily plus Amoxicillin 1000mg TID for up to 2 weeks Receives: Drug: Tegoprazan 50 mg, tablets, orally, qd; Drug: amoxicillin 1000mg tid |
| Esomeprazole 20 mg BID | Active comparator | 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. Receives: Drug: Esomeprazole 20mg BID; Drug: amoxicillin +clarithromycin+colloidal bismuth pectin BID |
| Tegoprazan 50 mg BID | Experimental | Tegoprazan 50 mg twice daily plus Amoxicillin plus Amoxicillin 1000mg TID for up to 2 weeks Receives: Drug: Tegoprazan 50 mg, tablets, orally, bid; Drug: amoxicillin 1000mg tid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post- Treatment
HP infection status will be determined by ^13C Urea Breath Test (^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory.
Measured: Week 4-8 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Nov 2023
- Primary completion30 Sep 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhang Xiaofeng,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhang Xiaofeng,MD, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647278
- Sponsor's protocol ID
- 2022-184
- Acronym
- TATH-1
- Status last verified
- Jan 2026
- First submitted
- 23 Nov 2022
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tegoprazan-Amoxicillin Dual Therapy Versus Esomeprazole-Based Bismuth Quadruple Therapy for First-Line Helicobacter Pylori Eradication: A Prospective, Randomized, Multicenter, Superiority Study (TATH-1)
- ClinicalTrials.gov ID
- NCT05647278
- Acronym / sponsor ID
- TATH-1 / 2022-184
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Eradication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Zhang Xiaofeng,MDUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tegoprazan 50mg QD | Experimental | Drug: Tegoprazan 50 mg, tablets, orally, qd, Drug: amoxicillin 1000mg tidTegoprazan 50 mg once daily plus Amoxicillin 1000mg TID for up to 2 weeks |
| Esomeprazole 20 mg BID | Active comparator | Drug: Esomeprazole 20mg BID, Drug: amoxicillin +clarithromycin+colloidal bismuth pectin BIDesomeprazole 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. |
| Tegoprazan 50 mg BID | Experimental | Drug: Tegoprazan 50 mg, tablets, orally, bid, Drug: amoxicillin 1000mg tidTegoprazan 50 mg twice daily plus Amoxicillin plus Amoxicillin 1000mg TID for up to 2 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged ≥18 years with Hp-positive first sterilization were included in this study.
- 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.
Key exclusion criteria (9 listed)
- acute upper gastrointestinal bleeding.
- active gastric or duodenal ulcer.
- acute gastric or duodenal mucosal lesions.
- previous eradication treatment of Helicobacter pylori.
- penicillin/furazolidone allergy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tegoprazan 50 mg, tablets, orally, qdTegoprazan 50 mg, tablets, orally, qd given in combination with amoxicillin 1000mg capsules, orally, tid for up to 2 weeks. | Drug | Tegoprazan 50mg QD |
| Esomeprazole 20mg BIDesomeprazole 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. | Drug | Esomeprazole 20 mg BID |
| Tegoprazan 50 mg, tablets, orally, bidTegoprazan 50 mg, tablets, orally, bid given in combination with amoxicillin 1000mg capsules, orally, tid for up to 2 weeks. | Drug | Tegoprazan 50 mg BID |
| amoxicillin +clarithromycin+colloidal bismuth pectin BIDamoxicillin 1000mg，clarithromycin 500mg bid，colloidal bismuth pectin 200mg bid for up to 2 weeks | Drug | Esomeprazole 20 mg BID |
| amoxicillin 1000mg tidamoxicillin 1000mg tid | Drug | Tegoprazan 50 mg BID, Tegoprazan 50mg QD |
Primary outcome
Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post- Treatment
Time frame: Week 4-8 post-treatment
HP infection status will be determined by ^13C Urea Breath Test (^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tegoprazan 50 mg, tablets, orally, qd, Esomeprazole 20mg BID and Tegoprazan 50 mg, tablets, orally, bid in people with Helicobacter Pylori Infection, run by Zhang Xiaofeng,MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post- Treatment (time frame: Week 4-8 post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.