HELICOBACTER PYLORI INFECTIONSPhase 4NCT07750938
Optimizing H. Pylori Eradication Regimen Under Intensified Acid Suppression
A Phase 4 study testing Keverprazan Hydrochloride 20 mg TID, Minocycline 100 mg (10-Day Regimen) and Keverprazan Hydrochloride 20 mg BID in people with HELICOBACTER PYLORI INFECTIONS, run by Qilu Hospital of Shandong University.
Trial summary
Background: Helicobacter pylori (H. pylori) infection affects approximately 50% of the global population and is closely associated with chronic gastritis, peptic ulcer disease, and gastric cancer. Eradication of H. pylori can reduce the overall risk of gastric cancer by 39%. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- What is being tested?
- Keverprazan Hydrochloride 20 mg TID, Minocycline 100 mg (10-Day Regimen) and Keverprazan Hydrochloride 20 mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 10 Aug 2028
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 years, male or female.
- Confirmed H. pylori infection, defined as a positive 13C-urea breath test (13C-UBT) plus at least one positive result from the following: stool H. pylori antigen test, rapid urease test, or gastric mucosal histopathology.
- No prior history of H. pylori eradication therapy.
Who cannot join
- Known allergy or hypersensitivity to any of the study drugs (keverprazan, amoxicillin, minocycline, bismuth).
- Acute upper gastrointestinal bleeding, active gastric or duodenal ulcer, acute gastric mucosal injury, or acute duodenal mucosal injury at screening.
- Severe underlying diseases, including: hepatic or renal insufficiency; immunosuppression; malignancy; severe central nervous system, cardiovascular, or respiratory diseases.
- Use of antibiotics, bismuth-containing preparations, or Chinese herbal medicines with antimicrobial effects within 4 weeks prior to the screening 13C-UBT; use of proton pump inhibitors (PPIs) or potassium-competitive acid blockers (P-CABs) within 2 weeks prior to the screening 13C-UBT.
- Risk behaviors such as drug abuse or alcohol dependence.
- Pregnancy, breastfeeding, or unwillingness to use contraception during the study period.
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- Current use of atazanavir sulfate or rilpivirine hydrochloride at screening.
- Requirement during the 14-day treatment period for any of the following medications: ergotamine, dihydroergotamine, probenecid, allopurinol, or methotrexate.
- Inability or unwillingness to provide informed consent.
About this study
Official title: Intensified Acid Suppression Strategy for Optimizing Helicobacter Pylori Eradication Regimen Duration and Drug Combination: A Multicenter, Open-Label, Randomized Controlled Trial
Background:
Helicobacter pylori (H. pylori) infection affects approximately 50% of the global population and is closely associated with chronic gastritis, peptic ulcer disease, and gastric cancer. Eradication of H. pylori can reduce the overall risk of gastric cancer by 39%. Current international guidelines recommend bismuth-containing quadruple therapy as first-line treatment; however, its complex regimen, adverse effects, cost, and suboptimal patient adherence limit its clinical application. Potent acid suppression is essential for H. pylori eradication, as maintaining an intragastric pH of 6-8 enhances the stability of acid-labile antibiotics and promotes bacterial replication, thereby increasing antibiotic susceptibility. Potassium-competitive acid blockers (P-CABs), such as vonoprazan, provide rapid, potent, and sustained acid suppression with dose-dependent effects. Keverprazan hydrochloride is a novel P-CAB with demonstrated dose-dependent acid suppression and favorable safety profiles in Phase I and Phase III studies. Whether an intensified P-CAB dosing strategy can allow treatment shortening and regimen simplification while maintaining high eradication rates warrants investigation.
Read more
Objective:
To evaluate the efficacy and safety of a 10-day high-dose keverprazan dual therapy versus a standard 14-day keverprazan-based bismuth quadruple therapy for first-line H. pylori eradication.
Study Design:
This is a multicenter, open-label, randomized controlled trial. Eligible participants (aged 18-70 years with confirmed H. pylori infection and no prior eradication history) will be randomly assigned in a 1:1 ratio to one of two treatment arms:
Arm A (Dual therapy, 10 days): Keverprazan 20 mg three times daily plus minocycline 100 mg twice daily.
Arm B (Quadruple therapy, 14 days): Keverprazan 20 mg twice daily, bismuth potassium citrate 240 mg twice daily, amoxicillin 1000 mg twice daily, and minocycline 100 mg twice daily.
The primary efficacy assessment will be performed at 6 weeks post-treatment using the 13C-urea breath test. A total of 316 participants (158 per arm) will be enrolled, accounting for an estimated 10% dropout rate.
Outcome Measures:
Primary Outcome: H. pylori eradication rate at 6 weeks after completion of treatment.
Secondary Outcomes: Safety and tolerability (adverse events, laboratory abnormalities) and treatment adherence.
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Being tested
- Keverprazan Hydrochloride 20 mg TID, Minocycline 100 mg (10-Day Regimen), Keverprazan Hydrochloride 20 mg BID, Bismuth Potassium Citrate 240 mg, Amoxicillin 1000 mg
- Keywords
- minocycline, helicobacter pylori, 10 day, dual therapy, keverprazan
- Medical subject headings
- cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keverprazan Hydrochloride 20 mg TIDDrug
Participants will receive keverprazan hydrochloride 20 mg orally three times daily for 10 days.
Minocycline 100 mg (10-Day Regimen)Drug
Participants will receive minocycline 100 mg orally twice daily for 10 days.
Keverprazan Hydrochloride 20 mg BIDDrug
Participants will receive keverprazan hydrochloride 20 mg orally twice daily for 14 days.
Bismuth Potassium Citrate 240 mgDrug
Participants will receive bismuth potassium citrate 240 mg orally twice daily for 14 days.
Amoxicillin 1000 mgDrug
Participants will receive amoxicillin 1000 mg orally twice daily for 14 days.
Minocycline 100 mg (14-Day Regimen)Drug
Participants will receive minocycline 100 mg orally twice daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| High-Dose Keverprazan Dual Therapy for 10 Days | Experimental | Keverprazan 20 mg tid Minocycline 100 mg bid (All medications administered orally for 10 consecutive days) Receives: Drug: Keverprazan Hydrochloride 20 mg TID; Drug: Minocycline 100 mg (10-Day Regimen) |
| Keverprazan-Based Quadruple Therapy for 14 Days | Experimental | Keverprazan 20 mg bid Bismuth Potassium Citrate 240 mg bid Amoxicillin 1000 mg bid Minocycline 100 mg bid (All medications administered orally for 14 consecutive days.) Receives: Drug: Keverprazan Hydrochloride 20 mg BID; Drug: Bismuth Potassium Citrate 240 mg; Drug: Amoxicillin 1000 mg; Drug: Minocycline 100 mg (14-Day Regimen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori Eradication Rate
The proportion of participants achieving successful H. pylori eradication, defined as a negative 13C-urea breath test result, assessed at 6 weeks after completion of treatment.
Measured: 6 weeks post-treatment
Secondary outcomes (2)
Incidence of Adverse Events
Measured: From first dose to 6 weeks post-treatment
Treatment Adherence Rate
Treatment adherence will be assessed by pill count and calculated using the following formula: Adherence (%) = (Actual number of doses taken / Expected number of doses) × 100%.
Measured: At the end of treatment (Day 10+3 for Arm A; Day 14+3 for Arm B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion10 Jul 2028 (estimated)
- Study completion10 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yueyue Li, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750938
- Sponsor's protocol ID
- V2.0/2026-05-15
- Status last verified
- Aug 2026
- First submitted
- 26 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensified Acid Suppression Strategy for Optimizing Helicobacter Pylori Eradication Regimen Duration and Drug Combination: A Multicenter, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07750938
- Acronym / sponsor ID
- V2.0/2026-05-15
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Keywords
- minocycline, helicobacter pylori, 10 day, dual therapy, keverprazan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 10 Jul 2028 (estimated)
- Study completion
- 10 Aug 2028 (estimated)
- First posted
- 6 Aug 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.
Background:
Helicobacter pylori (H. pylori) infection affects approximately 50% of the global population and is closely associated with chronic gastritis, peptic ulcer disease, and gastric cancer. Eradication of H. pylori can reduce the overall risk of gastric cancer by 39%. Current international guidelines recommend bismuth-containing quadruple therapy as first-line treatment; however, its complex regimen, adverse effects, cost, and suboptimal patient adherence limit its clinical application. Potent acid suppression is essential for H. pylori eradication, as maintaining an intragastric pH of 6-8 enhances the stability of acid-labile antibiotics and promotes bacterial replication, thereby increasing antibiotic susceptibility. Potassium-competitive acid blockers (P-CABs), such as vonoprazan, provide rapid, potent, and sustained acid suppression with dose-dependent effects. Keverprazan hydrochloride is a novel P-CAB with demonstrated dose-dependent acid suppression and favorable safety profiles in Phase I and Phase III studies. Whether an intensified P-CAB dosing strategy can allow treatment shortening and regimen simplification while maintaining high eradication rates warrants investigation.
Objective:
To evaluate the efficacy and safety of a 10-day high-dose keverprazan dual therapy versus a standard 14-day keverprazan-based bismuth quadruple therapy for first-line H. pylori eradication.
Study Design:
This is a multicenter, open-label, randomized controlled trial. Eligible participants (aged 18-70 years with confirmed H. pylori infection and no prior eradication history) will be randomly assigned in a 1:1 ratio to one of two treatment arms:
Arm A (Dual therapy, 10 days): Keverprazan 20 mg three times daily plus minocycline 100 mg twice daily.
Arm B (Quadruple therapy, 14 days): Keverprazan 20 mg twice daily, bismuth potassium citrate 240 mg twice daily, amoxicillin 1000 mg twice daily, and minocycline 100 mg twice daily.
The primary efficacy assessment will be performed at 6 weeks post-treatment using the 13C-urea breath test. A total of 316 participants (158 per arm) will be enrolled, accounting for an estimated 10% dropout rate.
Outcome Measures:
Primary Outcome: H. pylori eradication rate at 6 weeks after completion of treatment.
Secondary Outcomes: Safety and tolerability (adverse events, laboratory abnormalities) and treatment adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Dose Keverprazan Dual Therapy for 10 Days | Experimental | Drug: Keverprazan Hydrochloride 20 mg TID, Drug: Minocycline 100 mg (10-Day Regimen)Keverprazan 20 mg tid Minocycline 100 mg bid (All medications administered orally for 10 consecutive days) |
| Keverprazan-Based Quadruple Therapy for 14 Days | Experimental | Drug: Keverprazan Hydrochloride 20 mg BID, Drug: Bismuth Potassium Citrate 240 mg, Drug: Amoxicillin 1000 mg, Drug: Minocycline 100 mg (14-Day Regimen)Keverprazan 20 mg bid Bismuth Potassium Citrate 240 mg bid Amoxicillin 1000 mg bid Minocycline 100 mg bid (All medications administered orally for 14 consecutive days.) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 to 70 years, male or female.
- Confirmed H. pylori infection, defined as a positive 13C-urea breath test (13C-UBT) plus at least one positive result from the following: stool H. pylori antigen test, rapid urease test, or gastric mucosal histopathology.
- No prior history of H. pylori eradication therapy.
Key exclusion criteria (9 listed)
- Known allergy or hypersensitivity to any of the study drugs (keverprazan, amoxicillin, minocycline, bismuth).
- Acute upper gastrointestinal bleeding, active gastric or duodenal ulcer, acute gastric mucosal injury, or acute duodenal mucosal injury at screening.
- Severe underlying diseases, including: hepatic or renal insufficiency; immunosuppression; malignancy; severe central nervous system, cardiovascular, or respiratory diseases.
- Use of antibiotics, bismuth-containing preparations, or Chinese herbal medicines with antimicrobial effects within 4 weeks prior to the screening 13C-UBT; use of proton pump inhibitors (PPIs) or potassium-competitive acid blockers (P-CABs) within 2 weeks prior to the screening 13C-UBT.
- Risk behaviors such as drug abuse or alcohol dependence.
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 |
|---|---|---|
| Keverprazan Hydrochloride 20 mg TIDParticipants will receive keverprazan hydrochloride 20 mg orally three times daily for 10 days. | Drug | High-Dose Keverprazan Dual Therapy for 10 Days |
| Minocycline 100 mg (10-Day Regimen)Participants will receive minocycline 100 mg orally twice daily for 10 days. | Drug | High-Dose Keverprazan Dual Therapy for 10 Days |
| Keverprazan Hydrochloride 20 mg BIDParticipants will receive keverprazan hydrochloride 20 mg orally twice daily for 14 days. | Drug | Keverprazan-Based Quadruple Therapy for 14 Days |
| Bismuth Potassium Citrate 240 mgParticipants will receive bismuth potassium citrate 240 mg orally twice daily for 14 days. | Drug | Keverprazan-Based Quadruple Therapy for 14 Days |
| Amoxicillin 1000 mgParticipants will receive amoxicillin 1000 mg orally twice daily for 14 days. | Drug | Keverprazan-Based Quadruple Therapy for 14 Days |
| Minocycline 100 mg (14-Day Regimen)Participants will receive minocycline 100 mg orally twice daily for 14 days. | Drug | Keverprazan-Based Quadruple Therapy for 14 Days |
Primary outcome
H. pylori Eradication Rate
Time frame: 6 weeks post-treatment
The proportion of participants achieving successful H. pylori eradication, defined as a negative 13C-urea breath test result, assessed at 6 weeks after completion of treatment.
2 secondary outcomes
Incidence of Adverse Events
Time frame: From first dose to 6 weeks post-treatment
Treatment Adherence Rate
Time frame: At the end of treatment (Day 10+3 for Arm A; Day 14+3 for Arm B)
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 6 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Keverprazan Hydrochloride 20 mg TID, Minocycline 100 mg (10-Day Regimen) and Keverprazan Hydrochloride 20 mg BID in people with HELICOBACTER PYLORI INFECTIONS, run by Qilu Hospital of Shandong University.
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 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: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
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?
H. pylori Eradication Rate (time frame: 6 weeks 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 6 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.