A Study Reviewing Medical Records of Adults With Helicobacter Pylori Infections in China

Takeda

Status: Completed

Conditions: Helicobacter Pylori

Study type: Observational

Funder types: Industry

Identifiers

NCT05073367

Vonoprazan-4008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.

Exclusion criteria

Not applicable.

Trial design

23,000 participants in 1 patient group

Participants with H. Pylori

Description:

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.