ClinicalTrials.gg
RecruitingNCT05255978Updated Feb 25, 2022

A Prospective/Retrospective, Observational Follow-up Study of Chronic Hepatitis B With Non-alcoholic Fatty Liver Disease.

An observational study in the Effect of NAFLD on CHB, sponsored by Qin Ning. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-25.

Sponsored by Qin Ning · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2023, 3 years 4 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • the Effect of NAFLD on CHB
03

In context

Non-alcoholic Fatty Liver Disease

1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 153 across 390 observational studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

Qin Ning is the lead sponsor of 11 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

age > 18 years chronic hepatitis B patients

Eligibility criteria

Inclusion Criteria: age > 18 years, chronic patients -

Exclusion Criteria: patients with chronic or D and 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, hepatitis, Wilson's disease), or on medications known to induce hepatic steatosis (including , methotrexate, and tamoxifen), and pregnancy.

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Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Patient registry
No
Biospecimen retention
None retained
06

What researchers measure

Primary outcomes

  1. disease progression

    the effect of NAFLD on CHB

    Time frame: 3 years to 10 years

07

Study locations

1 of 1 sites recruiting
  • Department and Institute of Infectious Disease
    Wuhan, Hubei 430030, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05255978
Lead sponsor
Qin Ning
Responsible party
Qin Ning (Director and Chair of Department of Infectious Diseases, Tongji Hospital) — Sponsor-investigator
First posted
Feb 25, 2022
Start date
Feb 24, 2022 (estimated)
Primary completion
Jun 24, 2023 (estimated)
Completion
Jun 24, 2030 (estimated)
Last update
Feb 25, 2022

Study contacts

Ning Qin, Doctor
Contact
qning@vip.sina.com
83662391 ext. 8627
Meifang Han, Doctor
Contact
mfan@foxmail.com
83662391 ext. 8627

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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