Clinical trial NCT05073367: A Study Reviewing Medical Records of Adults With Helicobacter Pylori Infections in China
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-10-11
Enrollment: 23000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult participants diagnosed with H. pylori infection or with positive record of H. pylori diagnostic testing will be included in this study.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Each Eradication Regimen Initially Prescribed After Index Date
timeFrame: Up to 36 months
Secondary outcomes:
measure: Percentage of Each Eradication Therapy's Treatment Duration From the Date of Prescription Until the Termination
timeFrame: From date of prescription up to 14 days
measure: Percentage of Each Diagnostic Testing Used Before the Prescription of Eradication Therapy
timeFrame: Up to 36 months
measure: Percentage of Each Efficacy Evaluation Testing After the Termination of Eradication Therapy
timeFrame: Up to 36 months
measure: Percentage of the Duration From the Termination of Eradication Therapy Until the Efficacy Evaluation Testing
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital Affiliated to Shandong First Medical University
state: Shandong
city: Shanghai
country: China
facility: Shanghai Tenth Peoples Hospital
state: Shanghai
city: Chongqing
country: China
facility: Army Medical Center of PLA
state: Sichuan
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Provincial Peoples Hospital
state: Zhejiang
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: