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The Relationship Between Long-term Oral Anti Hepatitis B Nucleoside Analogs and Hepatic Steatosis

Hepatic Steatosis Clinical Trial

Official title:
A Prospective Observational Study on the Relationship Between Long-term Oral Anti Hepatitis B Nucleoside Analogs and Hepatic Steatosis

Clinical Trial Summary

This study aims to investigate whether long-term use of nucleotide analogues could promote hepatic steatosis in patients with chronic hepatitis B. The degree of hepatic steatosis was observed after 3 years of antiviral treatment with nucleoside (acid) analogues for the first time to determine whether the long-term use of anti hepatitis B nucleoside (acid) analogues could promote hepatic steatosis. To explore the anti hepatitis B nucleotide analogues that can promote liver steatosis, so as to provide evidence-based medical evidence for the selection or adjustment of anti hepatitis B virus drugs in patients with chronic hepatitis B.

Clinical Trial Description

This is a single-center, prospective, observational study involving chronic hepatitis B patients from the Second Affiliated Hospital of Chongqing Medical University. Research implementation process and route Recruitment object: Patients with chronic hepatitis B, defined as persistent hepatitis B surface antigen positive for ≥ 6 months, (aged ≥ 18, treatment-naive ) were consecutively recruited for outpatient routine examination between July 2021 and December 2022. We excluded patients with prior history of hepatocellular carcinoma, concomitant hepatitis C virus or human immunodeficiency virus infection, primary biliary cirrhosis, Wilson's disease, autoimmune hepatitis, significant alcohol intake (≥ 30 g per day for male, or ≥ 20 g per day for female), on steatogenic medications, prior liver transplantation. The basic information and various examination indexes of the patients were collected, and the patients were informed that they needed to go to the outpatient clinic of our hospital for follow-up examination every 1 year, with a total follow-up of 3 years. Data to be collected: general medical history characteristics: medical record number, name, gender, age, , enrollment time, contact information, and name of anti hepatitis B drugs. Examination and inspection indicators: liver function, renal function, blood chart analysis, blood lipid, hepatitis B two half and half, anti hepatitis C virus, anti hepatitis D virus, AIDS syphilis screening, high precision hepatitis B virus-DNA quantification, abdominal color Doppler ultrasound (if necessary CT or MR), transient elastography of the liver. Follow up: after enrollment, the relevant examination indexes were rechecked every 1 year. The follow-up period was 3 years. Statistical analysis: after a three-year follow-up, the data collected were tested by t-test and multivariate Cox analysis to analyze whether the long-term use of anti hepatitis B nucleoside (acid) analogues could promote hepatic steatosis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05416008
Study type Observational
Source The Second Affiliated Hospital of Chongqing Medical University
Contact
Status Enrolling by invitation
Phase
Start date July 1, 2021
Completion date December 31, 2025
View Details
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