Optimization of Vonoprazan--amoxicillin Dual Therapy for Eradicating Helicobacter Pyloriinfection

Study Overview
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Brief Summary
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Helicobacter pylori infection is closely related to gastritis, peptic ulcer, mucosa-associated lymphoid tissue lymphoma and gastric cancer. Eradication of HP can significantly improve and reduce HP-related diseases. International and domestic guidelines recommend a 10-14 day quadruple regimen containing bismuth as first-line treatment, achieving an eradication rate of more than 80%. However, some disadvantages of these quadruple regimens, such as severe adverse reactions, high medical costs and low compliance, prevent their application in clinical practice. Studies at home and abroad have shown that high-dose proton pump inhibitors 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. And because it is a single antibiotic therapy, we do not expect this regimen to increase antibiotic resistance rates for HP. The maintenance of gastric PH > 6 is one of the key factors for HP eradication. The acid inhibition effect of proton pump mainly depends on the degree of individual metabolism of proton pump. Vonoprazan fumarate, a new competitive potassium acid blocker, is not affected by gene polymorphism, and has the advantage of stronger and longer inhibition effect on gastric acid compared with proton pump inhibitors. In most parts of China, HP is characterized by high infection rate and antibiotic resistance rate, requiring higher eradication rate and safety regimen.This study aimed to evaluate two different amoxicillin dosages (1 g b.i.d. vs. 0.75 g q.i.d.) and two different durations of therapy (14 vs.10 days) to gain insights of the effectiveness of VA dual therapy .

Official Title
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Optimization of Vonoprazan--amoxicillin Dual Therapy for Eradicating Helicobacter pyloriinfection-a Multicenter, Prospective, Randomized, Parallel-controlled Study

Conditions
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Helicobacter Pylori Eradication Rate

Intervention / Treatment
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* Drug: vonoprazan fumarate + high dose amoxicillin（H-10d）
* Drug: vonoprazan fumarate + low dose amoxicillin（L-10d)
* Drug: vonoprazan fumarate + amoxicillin（H-14d)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-70, regardless of gender; HP positive in 13C/14C breath test or pathological test; HP eradication has never been performed in the past; Based on the consensus of helicobacter pylori in 2017, it conforms to the HP eradication guideline; The patient voluntarily signed the informed consent. Exclusion Criteria: History of drug allergy in this study; Liver and kidney dysfunction; Cardiopulmonary insufficiency; History of malignant tumor; Taking clopidogrel, warfarin and other drugs simultaneously may affect CYP2C19 metabolism; Pregnant or lactating women; Patients with severe mental illness; Those planning pregnancy; Previous upper gastrointestinal surgery history; Participated in any other clinical investigator in the last 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: H-VA-dual-10<br>10 days(vonoprazan fumarate tablets 20 mg/time, 2 times/day, oral +Amoxicillin 750mg/ time, 4 times/day, oral) | Drug: vonoprazan fumarate + high dose amoxicillin（H-10d）<br>* vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin 750mg/ time, 4 times/day, oral, for 10d<br>|
| Experimental: L-VA-dual-10<br>10 days(vonoprazan fumarate tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 2 times/day, oral) | Drug: vonoprazan fumarate + low dose amoxicillin（L-10d)<br>* vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin1000mg/ time, 2 times/day, oral, for 10d<br>|
| Active Comparator: H-VA-dual-14<br>14 days(vonoprazan fumarate tablets 20 mg/time, 2 times/day, oral +Amoxicillin 750mg/ time, 4 times/day, oral) | Drug: vonoprazan fumarate + amoxicillin（H-14d)<br>* vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin 750mg/ time, 4 times/day, oral, for 14d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H. pylori eradication rate | Rate of h. pylori successfully eradicated；13C-urea breath testthat will be used to assess this outcome measure | 6 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event | Rate of adverse event, serious adverse event; Questionnaire that will be used to assess this outcome measure. | 6 week | 
| Medical financial burden | Medical financial burden；Questionnaire that will be used to assess this outcome measure. | 6 week |