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Efficacy and safety of vonoprazan dual therapy for Helicobacter pylori eradication

Efficacy and safety of vonoprazan dual therapy for Helicobacter pylori eradication

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105014
Enrollment
Unknown
Registered
2025-06-26
Start date
2025-06-30
Completion date
Unknown
Last updated
2025-06-30

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

Conditions

Helicobacter pylori infection

Interventions

VA Dual 14d Therapy Group (Study 1):Received vornorasen fumarate 20mg, 30min before meals, bid amoxicillin capsules, 1000mg, 30min after meals, and oral TID for 14d
VBAC Quadruple 14d Therapy Group (Study 1):Vonorasan fumarate 20mg, oral bid 30min before meals, bismuth potassium citrate capsules 240mg, 30min before meals, oral bid amoxicillin capsules 1000mg, 30m
VA Dual 14d Therapy Group (Study II):Received vornorasen fumarate 20mg, 30min before meals, bid amoxicillin capsules, 1000mg, 30min after meals, and oral TID for 14d
VBAM 14d Therapy Group (Study 2):Received vonorasan fumarate 20mg, oral bid bismuth potassium citrate capsule 240mg, oral bid 30min before meal, amoxicillin capsule 1000mg, 30min oral bid minocycline
L-VA dual 14d therapy group (Study 3):Received vornorasen fumarate 20mg, 30min before meals, bid amoxicillin capsules, 750mg, 30min after meals, and oral TID for 14d
L-VA-add 14d therapy group (Study 3):Received vornorrasan fumarate 20mg, oral bid 30min before meals, amoxicillin capsules 750mg, oral TID probiotics (Bifidobacterium triple viable 630mg bid or compou
H-VA Dual 14d Therapy Group (Study 3):Received vornorasen fumarate 20mg, 30min before meals, bid amoxicillin capsules, 1000mg, 30min after meals, and oral TID for 14d
VA Dual 10d Therapy Group (Study IV):Received vornorasen fumarate 20mg, oral bid 30min before meals, amoxicillin capsules 1000mg, 30min after meals, oral TID for 10d
VA-add 10d therapy group (Study 4):Received vonorasen fumarate 20mg, oral bid amoxicillin capsules 1000mg, 30min postprandial 30min oral TID probiotics(Bifidoba

Sponsors

Bejing Tongren Hospital, Capital Medical Uniersity
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years, gender is not limited (Study 6: age 60-75 years); 2. Those who are positive for Helicobacter pylori (positive for Helicobacter pylori on 13C/14C-UBT or histopathological examination); 3. Initial treatment

Exclusion criteria

Exclusion criteria: 1.Patients who have previously received treatment for Helicobacter pylori; 2.Patients allergic to any investigational drug; 3.Patients with significant organ dysfunction such as cardiac, respiratory, renal and nervous system diseases and malignant tumors, etc.; 4.Patients who have used antibiotics or bismuth within 4 weeks prior to enrollment, or acid suppressants within 2 weeks prior to enrollment; 5.Pregnant or lactating women; 6.Other situations that investigators believe unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Hp eradication rate for the ITT analysis set;Hp eradication rate of the mITT analysis set;HP eradication rate for the PP analysis set;

Secondary

MeasureTime frame
Treatment adherence;

Countries

China

Contacts

Public ContactJianhong Chen

Bejing Tongren Hospital, Capital Medical Uniersity

chenjianhong829@126.com+86 10 5826 6053

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026