Impact of Fatty Liver on Hepatitis B Therapy

NCT06535048 | Active Not Recruiting DMC

• 3 other identifiers: AV-FLCHBTJWJ2022XK034TJYXZDXK-059B
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary goal of treating chronic hepatitis B(CHB) is to achieve maximal suppression of HBV replication, thereby reducing hepatocyte inflammation, necrosis, and liver fibrosis. Among various treatment strategies, antiviral therapy plays a crucial role. The prevalence of fatty liver disease (FLD) has continued to increase in recent decades. This study aims to accurately diagnose the pathological state of patients through liver biopsy and conduct a five-year follow-up to explore the impact of FLD on the efficacy of CHB treatment and to identify factors influencing adverse outcomes.

Conditions

Fatty Liver Disease; Chronic Hepatitis B; Antiviral Treatment

Outcome Measures

Primary Outcomes (2)

• Comparison of virological levels in serum

  The incidence of negativity for HBV DNA, HBsAg, and HBeAg, defined as serum levels less than 20 IU/mL, 0.05 IU/mL, and 1.0 S/CO, respectively.

  5 years

• Comparison of liver function improvement

  Liver function was assessed by measuring serum ALT, AST, and GGT levels during treatment.

  5 years

Secondary Outcomes (2)

• Impact of Fatty Liver on the Incidence of Adverse Outcomes in CHB Patients

  5 years

• Factors affecting adverse outcomes in patients with chronic hepatitis B

  5 years

Study Arms (2)

Fatty Liver

Hepatitis B patients with fatty liver

Drug: Entecavir；Tenofovir Disoproxil Fumarate (TDF)； Tenofovir alafenamide fumarate (TAF)；Interferons

Non-Fatty Liver

Hepatitis B patients without fatty liver

Drug: Entecavir；Tenofovir Disoproxil Fumarate (TDF)； Tenofovir alafenamide fumarate (TAF)；Interferons

Interventions

Entecavir；Tenofovir Disoproxil Fumarate (TDF)； Tenofovir alafenamide fumarate (TAF)；Interferons DRUG

Entecavir: Participants will receive Entecavir 0.5 mg orally once daily for the duration of the study. Tenofovir Disoproxil Fumarate (TDF): Participants will receive TDF 300 mg orally once daily for the duration of the study. Tenofovir alafenamide fumarate (TAF): Participants will receive TAF 25 mg orally once daily for the duration of the study. Interferon (IFN): Participants will receive IFN 180 µg subcutaneously once weekly for at least 12 weeks.

Also known as: Entecavir: Baraclude, Tenofovir Disoproxil Fumarate (TDF): Viread, Tenofovir Alafenamide Fumarate (TAF): Vemlidy, Pegylated Interferon Alpha (Peg-IFN-α): Pegasys

Fatty Liver; Non-Fatty Liver

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included patients between the ages of 18 and 75 who underwent liver biopsies and were diagnosed with chronic hepatitis B (CHB), all of whom received antiviral therapy for the first time. Patients were divided into two groups according to whether they had fatty liver. All patients had a complete history, including B-ultrasound, fiber scan, hepatitis B serology, liver function tests and other examination data.

You may qualify if:

• Aged ≥18 and ≤75 years old, regardless of gender;
• The patient had a positive hepatitis B marker and met the criteria for current hepatitis B virus infection (hepatitis B combined with fatty liver group);
• Liver pathology indicated fatty liver (hepatitis B combined with fatty liver group);
• All patients have complete medical history, B-ultrasound, FibroSan, hepatitis B five items, liver function and other laboratory test data.

You may not qualify if:

• Aged \<18 or \>75 years old;
• Patients diagnosed with or previously diagnosed with HCC;
• Those who are co-infected with other hepatitis viruses (HAV, HCV, HDV, HEV) or HIV or syphilis;
• The follow-up data of patients are seriously missing.

Sponsors & Collaborators

• Tianjin Second People's Hospital: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Hepatitis B, Chronic

Interventions

entecavir; Tenofovir

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: August 2, 2024
• Study Start: January 1, 2015
• Primary Completion: June 30, 2019
• Study Completion: August 31, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share