A Study Reviewing Medical Records of Adults With Helicobacter Pylori Infections in China
A Retrospective Observational Real-world Study to Evaluate Diagnosis Pattern, Treatment Pattern and Effectiveness of Eradication Treatment in Helicobacter Pylori (H. Pylori) Patients in China
1 other identifier
observational
23,000
1 country
5
Brief Summary
The main aim of the study is to review treatment therapies in people with Helicobacter pylori (H. pylori) infections in standard hospital settings in China. In this study, the study doctors will review medical records of participants who have had H. pylori infections any time from 1st January 2019 to 31st December 2021. This study is about collecting existing data only; participants are not treated and do not need to visit a study doctor during this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2021
CompletedFirst Posted
Study publicly available on registry
October 11, 2021
CompletedStudy Start
First participant enrolled
September 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2023
CompletedApril 18, 2023
April 1, 2023
7 months
October 8, 2021
April 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Each Eradication Regimen Initially Prescribed After Index Date
Eradication therapy in this study includes standard bismuth quadruple therapy, standard triple therapy, and dual therapy. Eradication therapy will be identified according to the combination of drugs that are prescribed on the same day. Index date will be defined as first diagnosis date or the first date of a positive result of H. pylori diagnostic testing whichever came first during the participant identification period. For the percentage calculation of each eradication regimen, the denominator is the total usage count of all standard eradication therapies taken by eligible participants and the numerator is the total usage count of each eradication therapy.
Up to 36 months
Secondary Outcomes (4)
Percentage of Each Eradication Therapy's Treatment Duration From the Date of Prescription Until the Termination
From date of prescription up to 14 days
Percentage of Each Diagnostic Testing Used Before the Prescription of Eradication Therapy
Up to 36 months
Percentage of Each Efficacy Evaluation Testing After the Termination of Eradication Therapy
Up to 36 months
Percentage of the Duration From the Termination of Eradication Therapy Until the Efficacy Evaluation Testing
Up to 36 months
Study Arms (1)
Participants with H. Pylori
Participants having evidence of H. pylori infection or having a positive result of H. pylori diagnostic testing recorded at inpatient or outpatient visits using pre-existing electronic medical record data in China will be observed retrospectively for 54 months.
Eligibility Criteria
Adult participants diagnosed with H. pylori infection or with positive record of H. pylori diagnostic testing will be included in this study.
You may qualify if:
- \. Participants with a record of H. pylori infection diagnosis or positive result of H. pylori diagnostic testing between 1st January 2019 and 31st December 2021.
You may not qualify if:
- Not applicable.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (5)
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250021, China
Shanghai Tenth Peoples Hospital
Shanghai, Shanghai Municipality, 200072, China
Army Medical Center of PLA
Chongqing, Sichuan, 400042, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300190, China
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, 314408, China
Related Publications (1)
Xu C, Pan W, Zhao Y, Li P, Zhou F, Xie L, Xu H. Diagnosis, Treatment Patterns and Eradication Success for Helicobacter pylori Infections in China: A Retrospective Observational Real-World Study. JGH Open. 2025 Oct 10;9(10):e70232. doi: 10.1002/jgh3.70232. eCollection 2025 Oct.
PMID: 41079532DERIVED
Related Links
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2021
First Posted
October 11, 2021
Study Start
September 21, 2022
Primary Completion
April 12, 2023
Study Completion
April 12, 2023
Last Updated
April 18, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.