Helicobacter PyloriNCT05073367
A Study Reviewing Medical Records of Adults With Helicobacter Pylori Infections in China
An observational study of Helicobacter Pylori, run by Takeda at 5 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori
- How many people
- 23,000 participants
- Where
- 5 sitesChina
- Study dates
- 21 Sep 2022to 12 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants diagnosed with H. pylori infection or with positive record of H. pylori diagnostic testing will be included in this study.
Who may be able to join
- 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.
Who cannot join
- Not applicable.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Army Medical Center of PLA
Chongqing, Sichuan, 400042
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, 314408
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250021
Shanghai Tenth Peoples Hospital
Shanghai, Shanghai Municipality, 200072
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300190
About this study
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
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.
Read the 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.
- Conditions
- Helicobacter Pylori
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 36 months
Secondary outcomes (4)
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.
Measured: From date of prescription up to 14 days
Percentage of Each Diagnostic Testing Used Before the Prescription of Eradication Therapy
- 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.
Measured: Up to 36 months
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.
Measured: Up to 36 months
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) .
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start21 Sep 2022
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter PyloriStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 23,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073367
- Sponsor's protocol ID
- Vonoprazan-4008
- Status last verified
- Apr 2023
- First submitted
- 8 Oct 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41079532
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05073367
- Acronym / sponsor ID
- Vonoprazan-4008
- Conditions
- Helicobacter Pylori
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23,000 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants diagnosed with H. pylori infection or with positive record of H. pylori diagnostic testing will be included in this study.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Not applicable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Each Eradication Regimen Initially Prescribed After Index Date
Time frame: Up to 36 months
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.
4 secondary outcomes
Percentage of Each Eradication Therapy's Treatment Duration From the Date of Prescription Until the Termination
Time frame: From date of prescription up to 14 days
Percentage of Each Diagnostic Testing Used Before the Prescription of Eradication Therapy
Time frame: Up to 36 months
Percentage of Each Efficacy Evaluation Testing After the Termination of Eradication Therapy
Time frame: Up to 36 months
Percentage of the Duration From the Termination of Eradication Therapy Until the Efficacy Evaluation Testing
Time frame: Up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 41079532Xu 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.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori, run by Takeda at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Each Eradication Regimen Initially Prescribed After Index Date (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05073367, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.