Helicobacter InfectionPhase 3NCT07904429
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
A Phase 3 study testing Minocycline, Keverprazan and Amoxicillin in people with Helicobacter Infection, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
This study aims to compare the efficacy and safety of keverprazan-minocycline dual therapy versus bismuth-based quadruple therapy for Helicobacter pylori eradication, focusing on eradication rates, patient adherence, and the incidence of adverse drug reactions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Infection
- What is being tested?
- Minocycline, Keverprazan and Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2026to 30 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years;
- Positive H. pylori status confirmed by 13C-urea breath test and no prior history of eradication therapy;
- Voluntary participation and provision of written informed consent
Who cannot join
- Allergy to any study medication (e.g., minocycline, keverprazan, amoxicillin);
- Confirmed active peptic ulcer disease;
- Prior history of H. pylori eradication treatment;
- Use of antibiotics or bismuth agents within 4 weeks before treatment initiation, or use of proton pump inhibitors within 2 weeks;
- Current use of corticosteroids, nonsteroidal anti-inflammatory drugs, or anticoagulants;
- History of esophageal or gastric surgery;
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- Pregnancy or lactation;
- Severe comorbidities, including hepatic, cardiovascular, pulmonary, or renal disease;
- Alcohol abuse;
- Gastric mucosa-associated lymphoid tissue lymphoma, malignant tumors, peptic ulcer disease, or bronchial asthma;
- Concurrent use of specific medications: atazanavir or rilpivirine, tricyclic antidepressants, levodopa, acetaminophen, guaifenesin/dextromethorphan, monoamine oxidase inhibitors, tramadol, or similar agents.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Keverprazan-minocycline Dual Therapy With Different Treatment Durations Versus Bismuth-based Quadruple Therapy for Helicobacter Pylori Eradication: an Open-label, Multicenter, Randomized, Non-inferiority Trial.
This study aims to compare the efficacy and safety of keverprazan-minocycline dual therapy versus bismuth-based quadruple therapy for Helicobacter pylori eradication, focusing on eradication rates, patient adherence, and the incidence of adverse drug reactions.
- Conditions
- Helicobacter Infection
- Being tested
- Minocycline, Keverprazan, Amoxicillin, Colloidal Bismuth Pectin
- Keywords
- H. pylori
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
100 mg oral capsule, twice daily
KeverprazanDrug
20 mg oral tablet, twice daily
AmoxicillinDrug
1000 mg oral tablet, twice daily
Colloidal Bismuth PectinDrug
300 mg oral preparation, twice daily
| Study group | Role | What they receive |
|---|---|---|
| 10-day dual therapy | Experimental | Not described Receives: Drug: Minocycline; Drug: Keverprazan |
| 14-day dual therapy | Experimental | Not described Receives: Drug: Minocycline; Drug: Keverprazan |
| 14-day quadruple therapy | Active comparator | Not described Receives: Drug: Minocycline; Drug: Keverprazan; Drug: Amoxicillin; Drug: Colloidal Bismuth Pectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication rate
Measured: 4-6 weeks after completion of the last dose
Rate of treatment adherence
follow-up conducted via WeChat or telephone
Measured: assessed on day 7，day 10 and day 14 of eradication therapy
Rate of adverse events
follow-up conducted via WeChat or telephone
Measured: assessed on day 7 ,day 10 and day 14 of eradication therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start15 Jul 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter InfectionStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 612 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenyu Zhang, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904429
- Sponsor's protocol ID
- MR-32-26-049733
- Status last verified
- Nov 2026
- First submitted
- 18 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Keverprazan-minocycline Dual Therapy With Different Treatment Durations Versus Bismuth-based Quadruple Therapy for Helicobacter Pylori Eradication: an Open-label, Multicenter, Randomized, Non-inferiority Trial.
- ClinicalTrials.gov ID
- NCT07904429
- Acronym / sponsor ID
- MR-32-26-049733
- Conditions
- Helicobacter Infection
- Keywords
- H. pylori
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 612 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Oct 2026 (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.
This study aims to compare the efficacy and safety of keverprazan-minocycline dual therapy versus bismuth-based quadruple therapy for Helicobacter pylori eradication, focusing on eradication rates, patient adherence, and the incidence of adverse drug reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10-day dual therapy | Experimental | Drug: Minocycline, Drug: Keverprazan |
| 14-day dual therapy | Experimental | Drug: Minocycline, Drug: Keverprazan |
| 14-day quadruple therapy | Active comparator | Drug: Minocycline, Drug: Keverprazan, Drug: Amoxicillin, Drug: Colloidal Bismuth Pectin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years;
- Positive H. pylori status confirmed by 13C-urea breath test and no prior history of eradication therapy;
- Voluntary participation and provision of written informed consent
Key exclusion criteria (11 listed)
- Allergy to any study medication (e.g., minocycline, keverprazan, amoxicillin);
- Confirmed active peptic ulcer disease;
- Prior history of H. pylori eradication treatment;
- Use of antibiotics or bismuth agents within 4 weeks before treatment initiation, or use of proton pump inhibitors within 2 weeks;
- Current use of corticosteroids, nonsteroidal anti-inflammatory drugs, or anticoagulants;
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 |
|---|---|---|
| Minocycline100 mg oral capsule, twice daily | Drug | 10-day dual therapy, 14-day dual therapy, 14-day quadruple therapy |
| Keverprazan20 mg oral tablet, twice daily | Drug | 10-day dual therapy, 14-day dual therapy, 14-day quadruple therapy |
| Amoxicillin1000 mg oral tablet, twice daily | Drug | 14-day quadruple therapy |
| Colloidal Bismuth Pectin300 mg oral preparation, twice daily | Drug | 14-day quadruple therapy |
Primary outcome
H. pylori eradication rate
Time frame: 4-6 weeks after completion of the last dose
Rate of treatment adherence
Time frame: assessed on day 7，day 10 and day 14 of eradication therapy
follow-up conducted via WeChat or telephone
Rate of adverse events
Time frame: assessed on day 7 ,day 10 and day 14 of eradication therapy
follow-up conducted via WeChat or telephone
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Minocycline, Keverprazan and Amoxicillin in people with Helicobacter Infection, run by Nanjing First Hospital, Nanjing Medical University 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 5 Nov 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenyu Zhang (18951670222, zzy6565@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H. pylori eradication rate (time frame: 4-6 weeks after completion of the last dose). The study lists 3 primary outcomes in all. 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 5 Nov 2026.