the Effect of NAFLD on CHBNCT05255978
A Prospective/Retrospective, Observational Follow-up Study of Chronic Hepatitis B With Non-alcoholic Fatty Liver Disease.
An observational study of the Effect of NAFLD on CHB, run by Qin Ning at 1 site in China.
Trial summary
This is a prospective/retrospective, observational follow-up study of effects of fatty liver on chronic hepatitis B. Patients will join this study who undergo transient elastography with liver stiffness (LS) and CAP measurements or Ultrasonic examination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- the Effect of NAFLD on CHB
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2022to 24 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: age > 18 years chronic hepatitis B patients
Inclusion Criteria: age > 18 years, chronic hepatitis B patients -
Exclusion Criteria: patients with chronic hepatitis C or D and human immunodeficiency virus co-infection, excessive alcohol intake (≥30 g/d for men, ≥20 g/d for women), other chronic liver diseases (e.g. primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease), or on medications known to induce hepatic steatosis (including corticosteroids, methotrexate, and tamoxifen), and pregnancy.
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department and Institute of Infectious Disease
Wuhan, Hubei, 430030
Qin Ning, professor, qning@vip.sina.com
Meifang Han, professor, mfhan@foxmail.com
About this study
This is a prospective/retrospective, observational follow-up study of effects of fatty liver on chronic hepatitis B. Patients will join this study who undergo transient elastography with liver stiffness (LS) and CAP measurements or Ultrasonic examination. All recruited subjects will undergo comprehensive clinical, anthropometric and laboratory assessments at the time when transient elastography or Ultrasonic examination is performed. We plan to compare the relationship between chronic hepatitis B and non-alcoholic fatty liver disease. Patients will be divided into several groups based on the demand.
- Conditions
- the Effect of NAFLD on CHB
What is being measured
The primary outcome is the main question the study is designed to answer.
disease progression
the effect of NAFLD on CHB
Measured: 3 years to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start24 Feb 2022 (estimated)
- Primary completion24 Jun 2023 (estimated)
- Study completion24 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Effect of NAFLD on CHBStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qin Ning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qin Ning, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255978
- Sponsor's protocol ID
- TJ20210524
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective/Retrospective, Observational Follow-up Study of Chronic Hepatitis B With Non-alcoholic Fatty Liver Disease.
- ClinicalTrials.gov ID
- NCT05255978
- Acronym / sponsor ID
- TJ20210524
- Conditions
- the Effect of NAFLD on CHB
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Qin NingUniversity, hospital or other
- Study start
- 24 Feb 2022 (estimated)
- Primary completion
- 24 Jun 2023 (estimated)
- Study completion
- 24 Jun 2030 (estimated)
- First posted
- 25 Feb 2022 (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.
This is a prospective/retrospective, observational follow-up study of effects of fatty liver on chronic hepatitis B. Patients will join this study who undergo transient elastography with liver stiffness (LS) and CAP measurements or Ultrasonic examination. All recruited subjects will undergo comprehensive clinical, anthropometric and laboratory assessments at the time when transient elastography or Ultrasonic examination is performed. We plan to compare the relationship between chronic hepatitis B and non-alcoholic fatty liver disease. Patients will be divided into several groups based on the demand.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- age > 18 years chronic hepatitis B patients
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
disease progression
Time frame: 3 years to 10 years
the effect of NAFLD on CHB
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of the Effect of NAFLD on CHB, run by Qin Ning at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Qin, Doctor (83662391 ext. 8627, qning@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease progression (time frame: 3 years to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2022.