Helicobacter pylori
Conditions
Interventions
Experimental Group:Keverprazan Hydrochloride 20 mg per dose, twice daily + Amoxicillin 750 mg per dose, four times daily, for 14 days.
Control Grouop:Susceptibility-Guided Quadruple Therapy Regimen
Sponsors
The Sixth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Participants aged =18 years and =75 years at the time of signing the informed consent. 2.Participants who have undergone at least one prior standard H. pylori eradication treatment (PPI-based triple or quadruple therapy) and failed treatment. 3.Current H. pylori infection confirmed by 13C-Urea Breath Test (13C-UBT), rapid urease test, or H. pylori culture. 4.Participants who, in the investigator's opinion, are able to understand and comply with the protocol requirements. 5.Participants must sign a written informed consent form and any necessary privacy authorization documents, dated before the initiation of study procedures. 6.Female participants of childbearing potential who have regular or potential sexual activity with non-sterilized male partners must agree to use two effective methods of contraception from the time of informed consent until the end of the study
Exclusion criteria
Exclusion criteria: 1.Participants with gastric or duodenal ulcers and evidence of current or recent bleeding observed during endoscopy. 2.Participants diagnosed with gastric cancer through endoscopic biopsy. 3.Participants who have received any investigational drugs (including drugs used in post-marketing studies) within 30 days prior to the screening period. However, those who failed screening and did not receive the investigational drug may be included. 4.Participants who are researchers at the study site, their immediate family members, or individuals with conflicts of interest or potential pressure to consent to participation. 5.Participants with cutaneous lupus erythematosus or systemic lupus erythematosus. 6.Participants with clinical evidence of upper or lower gastrointestinal bleeding within 4 weeks prior to randomization. 7.Participants diagnosed with Zollinger-Ellison syndrome or other gastric acid hypersecretion disorders. 8.Participants with allergies or hypersensitivity to Keverprazan Hydrochloride (including its excipients: D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, crosslinked sodium carboxymethylcellulose, magnesium stearate, hypromellose, polyethylene glycol 8000, titanium dioxide, red iron oxide, or yellow iron oxide), PPIs, amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline, furazolidone, or excipients used in 13C-UBT (e.g., mannitol, citric acid, or aspartame). 9.Participants with a history of alcohol abuse, illicit drug use, or drug addiction within 12 months prior to screening, or those with a weekly alcohol intake exceeding 21 units (1 unit = 12 oz/300 ml beer, 1.5 oz/25 ml spirits, or 5 oz/100 ml wine). 10.Use of medications that may interfere with the 13C-UBT. Specifically:Within 30 days prior to 13C-UBT: antibiotics, bismuth agents, or antiprotozoal drugs.Within 14 days prior to 13C-UBT: H2-receptor antagonists, PPIs, or any interfering drugs such as sodium succinate. 11.Participants taking drugs contraindicated with clarithromycin, including colchicine, pimozide, ergot derivatives, tadalafil, terfenadine, astemizole, cisapride, simvastatin, lovastatin, atorvastatin, etc. (Pravastatin, fluvastatin, and rosuvastatin are permitted but should be used with caution). 12.Participants taking strong CYP2C19 inhibitors or inducers, such as fluconazole, fluoxetine, fluvoxamine, ticlopidine, rifampin, or ritonavir. 13.Participants taking strong CYP3A4 inhibitors or inducers, such as itraconazole, ketoconazole, indinavir, nelfinavir, ritonavir, saquinavir, or telithromycin. 14.Participants who have undergone surgeries that may affect gastric acid secretion, such as any form of gastrectomy or vagotomy. 15.Participants with significant medical histories or clinical manifestations involving the central nervous system, cardiovascular system, liver, lungs, kidneys, metabolism, gastrointestinal system, urinary system, reproductive endocrine system, or hematological system, which the investigator deems may affect study results or participant safety. 16.Participants with any history of malignancies, including MALT lymphoma. 17.Participants requiring hospitalization or surgery during the study or those who underwent major surgery within 30 days prior to the screening visit. 18.Participants with acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection. 19.Female participants who are pregnant, breastfeeding, planning to become pregnant, or planning to donate eggs during the stud
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Helicobacter pylori eradication rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation; Medication compliance;Antibiotic resistance rate;Risk factors affecting Helicobacter pylori eradication rate; | — |
Countries
China
Contacts
Public ContactXiang Peng
The Sixth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed