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

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Helicobacter Pylori Eradication Rate

Treatments: Drug: vonoprazan fumarate + amoxicillin（H-14d); Drug: vonoprazan fumarate + high dose amoxicillin（H-10d）; Drug: vonoprazan fumarate + low dose amoxicillin（L-10d)

Study type: Interventional

Funder types: Other

Identifiers

NCT05719831

HP

Details and patient eligibility

About

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 .

Enrollment: 516 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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516 participants in 3 patient groups

H-VA-dual-10

Experimental group

Description:

10 days(vonoprazan fumarate tablets 20 mg/time, 2 times/day, oral +Amoxicillin 750mg/ time, 4 times/day, oral)

Treatment:

Drug: vonoprazan fumarate + high dose amoxicillin（H-10d）

L-VA-dual-10

Experimental group

Description:

10 days(vonoprazan fumarate tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 2 times/day, oral)

Treatment:

Drug: vonoprazan fumarate + low dose amoxicillin（L-10d)

H-VA-dual-14

Active Comparator group

Description:

14 days(vonoprazan fumarate tablets 20 mg/time, 2 times/day, oral +Amoxicillin 750mg/ time, 4 times/day, oral)

Treatment:

Drug: vonoprazan fumarate + amoxicillin（H-14d)