Observational study on chronic hepatitis B and fatty liver disease
A Prospective/Retrospective, Observational Follow-up Study of Chronic Hepatitis B With Non-alcoholic Fatty Liver Disease.
This study looks at how non-alcoholic fatty liver disease affects people with chronic hepatitis B to better understand their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05255978 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the effects of non-alcoholic fatty liver disease (NAFLD) on patients with chronic hepatitis B (CHB). Participants will undergo transient elastography and ultrasonic examinations to assess liver stiffness and fat content. Comprehensive clinical, anthropometric, and laboratory assessments will be conducted at the time of these examinations. The study will categorize patients into different groups to analyze the relationship between CHB and NAFLD.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with chronic hepatitis B.
Not a fit: Patients with chronic hepatitis C or D, HIV co-infection, excessive alcohol intake, other chronic liver diseases, or those on certain medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how fatty liver disease impacts chronic hepatitis B, potentially leading to improved management strategies.
How similar studies have performed: While the specific relationship between NAFLD and CHB is being explored in this study, similar observational studies have shown promising results in understanding liver disease interactions.
Eligibility criteria
Show full inclusion / exclusion criteria
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. \-
Where this trial is running
Wuhan, Hubei
- Department and Institute of Infectious Disease — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Ning Qin, Doctor
- Email: qning@vip.sina.com
- Phone: 83662391
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.