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

Helicobacter Pylori Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05073367
• Other study ID #: Vonoprazan-4008
• Status: Completed
• Start date: September 21, 2022
• Est. completion date: April 12, 2023

Study information

• Verified date: April 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23000
• Est. completion date: April 12, 2023
• Est. primary completion date: April 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Pylori

Locations

Country	Name	City	State
China	Army Medical Center of PLA	Chongqing	Sichuan
China	Zhejiang Provincial Peoples Hospital	Hangzhou	Zhejiang
China	Shandong Provincial Hospital Affiliated to Shandong First Medical University	Jinan	Shandong
China	Shanghai Tenth Peoples Hospital	Shanghai	Shanghai
China	Tianjin First Central Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Each Eradication Therapy's Treatment Duration From the Date of Prescription Until the Termination	Duration of eradication therapy is defined as the days in a medication-taking interval, which is equal to dosage by unit. Eradication therapy in this study includes standard bismuth quadruple therapy, standard triple therapy, and dual therapy. The duration of eradication therapy will be categorized into categorical variables including 7 days, 10 days, 14 days, or others. For percentage calculation of treatment duration of each eradication therapy, the denominator is the total usage count of all eradication therapies taken by eligible participants and the numerator is the count of the categorized duration of each eradication therapy.	From date of prescription up to 14 days
Secondary	Percentage of Each Diagnostic Testing Used Before the Prescription of Eradication Therapy	H. pylori diagnostic testing includes non-invasive testing (urea breath testing [UBT], fecal antigen testing, serological testing) and invasive testing (polymerase chain reaction [PCR], culture, rapid urease test [RUT] and histology). For percentage calculation of each diagnosis before eradication therapy, the denominator is the total count of diagnostic testing and the numerator is the count of each type of diagnostic testing.	Up to 36 months
Secondary	Percentage of Each Efficacy Evaluation Testing After the Termination of Eradication Therapy	Efficacy evaluation testing is defined as H. pylori testing performed during the 28 days of efficacy evaluation period after treatment completion and this testing may extend to the follow-up period until observation period ends. For percentage calculation of efficacy evaluation testing after eradication therapy, the denominator is the total count of efficacy evaluation testing and the numerator is the count of each type of efficacy evaluation testing.	Up to 36 months
Secondary	Percentage of the Duration From the Termination of Eradication Therapy Until the Efficacy Evaluation Testing	The duration is defined as the time period between the last day of taking medication of eradication therapy and the day receiving efficacy evaluation testing. The duration of eradication therapy will be categorized into categorical variables including less than or equal to (<=) 4 weeks or greater than (>) 4 weeks. For percentage calculation of efficacy evaluation testing after each eradication therapy, the denominator is the total count of efficacy evaluation testing and the numerator is the count of duration (<=4 weeks or >4 weeks) .	Up to 36 months

External Links

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