A Phase 4 interventional study of Keverprazan Hydrochloride 20 mg TID and Minocycline 100 mg (10-Day Regimen) in HELICOBACTER PYLORI INFECTIONS, sponsored by Qilu Hospital of Shandong University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Qilu Hospital of Shandong University · Phase 4, Interventional, and Treatment
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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.
Qilu Hospital of Shandong University is the lead sponsor of 310 studies on the registry; 187 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Keverprazan 20 mg tid Minocycline 100 mg bid (All medications administered orally for 10 consecutive days)
Drug: Keverprazan Hydrochloride 20 mg TID · Drug: Minocycline 100 mg (10-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.)
Drug: Keverprazan Hydrochloride 20 mg BID · Drug: Bismuth Potassium Citrate 240 mg · Drug: Amoxicillin 1000 mg · Drug: Minocycline 100 mg (14-Day Regimen)
Participants will receive keverprazan hydrochloride 20 mg orally three times daily for 10 days.
Participants will receive minocycline 100 mg orally twice daily for 10 days.
Participants will receive keverprazan hydrochloride 20 mg orally twice daily for 14 days.
Participants will receive bismuth potassium citrate 240 mg orally twice daily for 14 days.
Participants will receive amoxicillin 1000 mg orally twice daily for 14 days.
Participants will receive minocycline 100 mg orally twice daily for 14 days.
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.
Time frame: 6 weeks post-treatment
Incidence of Adverse Events
Time frame: 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%.
Time frame: At the end of treatment (Day 10+3 for Arm A; Day 14+3 for Arm B)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Jul 2028, 23 months later.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Keverprazan · Bismuth
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