A Phase 3 interventional study of Keverprazan Hydrochloride tablets + high dose amoxicillin and Keverprazan Hydrochloride tablets + low dose amoxicillin in Helicobacter Pylori Eradication Rate, sponsored by Eighth Affiliated Hospital, Sun Yat-sen University. Recruiting at 4 sites in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Eighth Affiliated Hospital, Sun Yat-sen University · Phase 3, Interventional, and Treatment
Eradication of HP can significantly improve and reduce HP-related diseases. A 10-14 day quadruple regimen containing bismuth as first-line treatment, achieving an eradication rate of more than 85%. However, some disadvantages of these quadruple regimens, such as severe adverse reactions, high medical costs and low compliance, prevent their application in clinical practice. High-dose proton pump inhibitors (PPI) combined with amoxicillin can be used as the first-line treatment for HP eradication, with good efficacy and compliance and low rate of adverse reactions. However, the acid inhibition effect of PPI mainly depends on the degree of individual metabolism of proton pump,which might influence the eradication effect. Keverprazan, a new competitive potassium acid blocker(P-CAB), is not affected by gene polymorphism, and has the advantage of stronger and longer inhibition effect on gastric acid compared with PPIs. This study aimed to evaluate two different doses of therapy (1 g b.i.d. vs. 1.0 g t.i.d.) and two different durations of therapy (14 vs.10 days) to gain insights of the effectiveness of Keverprazan-amoxicillin dual therapy .
Eighth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 10 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
14 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 3 times/day, oral)
Drug: Keverprazan Hydrochloride tablets + high dose amoxicillin
14 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 2 times/day, oral)
Drug: Keverprazan Hydrochloride tablets + low dose amoxicillin
10 days(Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 3 times/day, oral)
Drug: Keverprazan Hydrochloride tablets + high dose amoxicillin(H-KA-10d)
Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral Amoxicillin 1000mg/ time, 3 times/day, oral, for 14 day
Also known as: H-KA-14d
Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral Amoxicillin 1000mg/ time, 2 times/day, oral, for 14 day
Also known as: L-KA-14d
Keverprazan Hydrochloride tablets 20 mg/time, 2 times/day, oral Amoxicillin 1000mg/ time, 3 times/day, oral, for 10 day
Also known as: H-KA-10d
H. pylori eradication rate
Rate of h. pylori successfully eradicated;13C-urea breath testthat will be used to assess this outcome measure
Time frame: 6 weeks
Adverse Event
Rate of adverse event, serious adverse event; Questionnaire that will be used to assess this outcome measure.
Time frame: 6 weeks
Medical financial burden
Medical financial burden;Questionnaire that will be used to assess this outcome measure.
Time frame: 6 weeks
Plan to share: No — The datasets used and analysed during the current study available from the corresponding author on reasonable request.
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Eighth Affiliated Hospital, Sun Yat-sen University