Helicobacter pylori eradication therapy with Vonoprazan, reduced dosage of amoxicillin, and clarithromycin for hemodialysis patients

JRCT ID: jRCTs031200237

Registered date:11/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Helicobacter pylori infection
• Date of first enrollment: 12/05/2023
• Target sample size: 23
• Study type: Interventional
• Intervention(s): Vonoprazan (20mg), amoxicillin (250mg), and clarithromycin (200mg) given on twice daily for 7days

Outcome(s)

• Primary Outcome: Eradication rate (PPS)

Secondary Outcome

(1) Eradication rate (PPS)
(2) Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients infected with Helicobacter pylori. Positive patients by Urea breath test, stool Helicobacter pylori antigen test, anti-Helicobacter pylori antibody test (blood), Helicobacter pylori culture are treated with infected.
Patients diagnosed as chronic gastritis, gastroduodenal ulcer, MALT lymphoma, idiopathic thrombocytopenic purpura, or after endoscopic treatment of early gastric cancer, and performed upper gastrointestinal endoscopy within a year.
Hemodialysis patients for end-stage renal failure.
Patients who give a written informed consent.

• Exclude criteria: Patients who have Helicobacter pylori eradication history. Pregnancy or lactation. Patients using stazanavir, rilpivirine, pimozide, ergotamine, suvorexant, lomitapide mesylate, tadalafil, ticagrelor, ibrutinib, asuna previr, ivavradine, venetoclax, lurasidone hydrochloride, anamorelin hydrochloride, finerenone, isavuconazonium sulfate, or colchicine. Patients who are disqualified for the study by physicians.

Related Information

• Primary Sponsor: Soichiro Sue
• Source(s) of Monetary Support: Yokohama City University