Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-01 @ 1:35 AM
Study NCT ID:
NCT07121205
Status:
COMPLETED
Last Update Posted:
2025-08-13
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Dose Dual Therapy for H. Pylori Eradication (RETRO-HP Study)
Sponsor:
Liyueyue
Organization:
Study Overview
Official Title:
Comparative Analysis of High-Dose Dual Therapies in First-Line Helicobacter Pylori Eradication: A Multicenter Retrospective Study
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RETROHP
Brief Summary:
Background:
High-dose dual therapy (HDDT) has emerged as a potential first-line treatment for Helicobacter pylori infection, but its efficacy and safety across different regimens and populations remain unclear. This study aimed to compare real-world outcomes of various HDDT protocols and identify factors influencing treatment failure.
Methods:
A multicenter retrospective analysis was conducted using data from 15 medical centers (January 2022-January 2025). Patients received one of four HDDT regimens: vonoprazan-amoxicillin for 10 days (VA-10) or 14 days (VA-14), esomeprazole-amoxicillin (EA), or tegoprazan-amoxicillin (TA). Primary outcomes included eradication rates (modified intention-to-treat analysis) and adverse events.
High-dose dual therapy (HDDT) has emerged as a potential first-line treatment for Helicobacter pylori infection, but its efficacy and safety across different regimens and populations remain unclear. This study aimed to compare real-world outcomes of various HDDT protocols and identify factors influencing treatment failure.
Methods:
A multicenter retrospective analysis was conducted using data from 15 medical centers (January 2022-January 2025). Patients received one of four HDDT regimens: vonoprazan-amoxicillin for 10 days (VA-10) or 14 days (VA-14), esomeprazole-amoxicillin (EA), or tegoprazan-amoxicillin (TA). Primary outcomes included eradication rates (modified intention-to-treat analysis) and adverse events.
Detailed Description:
This study is a multicenter, retrospective, observational study utilizing medical records of outpatients who received standard high-dose dual therapy (HDDT) for Helicobacter pylori eradication between January 2022 and January 2025. The aim was to compare the efficacy and adverse event rates of different HDDT regimens.
Collected data included:
Baseline demographics (age, sex, etc.)
Medical/lifestyle history
Treatment regimens
Adverse events
Compliance
All data were anonymized at collection, and no additional patient contact or information collection was required. Since this study involved only retrospective chart review without new interventions, patient consent was waived by the ethics committee.
Treatment Groups
Patients were categorized based on their actual prescribed regimens:
Amoxicillin + Vonoprazan (10-day course)
Amoxicillin + Vonoprazan (14-day course)
Amoxicillin + Tegoprazan (14-day course)
Amoxicillin + Esomeprazole (14-day course)
These groups were compared to assess differences in H. pylori eradication rates.
Study Characteristics No active intervention or real-time questionnaire collection was involved.
Complies with the real-world evidence (RWE) framework for retrospective studies.
Primary Outcome Eradication rate comparison between HDDT regimens (assessed via modified intention-to-treat analysis).
Secondary Outcomes Adverse event rates across different HDDT regimens.
Collected data included:
Baseline demographics (age, sex, etc.)
Medical/lifestyle history
Treatment regimens
Adverse events
Compliance
All data were anonymized at collection, and no additional patient contact or information collection was required. Since this study involved only retrospective chart review without new interventions, patient consent was waived by the ethics committee.
Treatment Groups
Patients were categorized based on their actual prescribed regimens:
Amoxicillin + Vonoprazan (10-day course)
Amoxicillin + Vonoprazan (14-day course)
Amoxicillin + Tegoprazan (14-day course)
Amoxicillin + Esomeprazole (14-day course)
These groups were compared to assess differences in H. pylori eradication rates.
Study Characteristics No active intervention or real-time questionnaire collection was involved.
Complies with the real-world evidence (RWE) framework for retrospective studies.
Primary Outcome Eradication rate comparison between HDDT regimens (assessed via modified intention-to-treat analysis).
Secondary Outcomes Adverse event rates across different HDDT regimens.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| KYLL-2025-07-009 | OTHER | Qilu Hospital of Shandong University | View |