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RCT of rescue eradication therapy with VAR versus VAS

A randomized controlled trial comparing Helicobacter pylori salvage eradication therapy with triple therapy of vonoprazan, amoxicillin, and rifabutin versus triple therapy of vonoprazan, amoxicillin, and sitafloxacin

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031250216
Enrollment
60
Registered
2025-07-07
Start date
2026-02-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori eradication therapy Helicobacter pylori

Interventions

Vonoprazan-amoxicillin-rifabutin treatment: Vonoprazan 20mg twice a day (40mg/day), amoxicillin 750mg 12 times a day (1500mg/day), rifabutin 150mg twice a day (300mg/day), all three drugs administered

Sponsors

Sue Soichiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Age 18 years or older at the time of enrollment (2) Patients with confirmed Helicobacter pylori infection (3) Patients who have failed first-line eradication therapy (PPI or PCAB + amoxicillin + clasithromycin for 1 week) or second-line eradication therapy (PPI or PCAB + amoxicillin + metronidazole for 1 week) approved for insurance coverage in Japan (4) Patients who have given consent to participate in this clinical study

Exclusion criteria

Exclusion criteria: (1) Pregnant or possibly pregnant patients (2) Breastfeeding patients (3) Patients with a history of allergies to the test drug (4) Patients taking drugs that are contraindicated for use with the study drug. (5) Patients with other serious diseases (liver failure, renal failure, heart failure, etc.) Liver function is based on a total bilirubin level of 1.5 mg/dL, and renal function is based on a creatinine level of 1.2 mg/dL. (6) Patients who are otherwise deemed unsuitable as subjects by the principal investigator (subinvestigator)

Design outcomes

Primary

MeasureTime frame
Eradication rate

Secondary

MeasureTime frame
Treatment compliance, Safety

Contacts

Public ContactSoichiro Sue

Yokohama City University Hospital

ssue@yokohama-cu.ac.jp+81-457872800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026