Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2026-01-02 @ 10:43 AM
Study NCT ID:
NCT05073367
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2021-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Reviewing Medical Records of Adults With Helicobacter Pylori Infections in China
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-04
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:
None
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.
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.
Detailed Description:
This is a non-interventional, retrospective cohort study of participants who have evidence of H. pylori infection using pre-existing electronic medical record data in China. This study will evaluate the distribution of methods of eradication therapy among participants who received medications that were used in the eradication therapy for H. pylori infection.
Retrospective de-identified participant-level data will be collected primarily from hospitals in China between 1st January 2019 to 31st December 2021. The extracted electronic medical record dataset will include patient demographic information, visit information, diagnosis information, treatment information, and cost information (if available). All the participants will be assigned to a single observational cohort:
• Participants with H. pylori
This multi-center study will be conducted in China. The overall study duration will be approximately 54 months.
Retrospective de-identified participant-level data will be collected primarily from hospitals in China between 1st January 2019 to 31st December 2021. The extracted electronic medical record dataset will include patient demographic information, visit information, diagnosis information, treatment information, and cost information (if available). All the participants will be assigned to a single observational cohort:
• Participants with H. pylori
This multi-center study will be conducted in China. The overall study duration will be approximately 54 months.
Study Oversight
Has Oversight DMC:
False
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?: