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Active, Not Recruiting

NCT Number: NCT06535048

Impact of Fatty Liver on Hepatitis B Therapy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

Chronic hepatitis B (CHB) remains a serious threat to people's health. As of 2019, approximately 296 million people (3.9% of the world's population) were infected with the HBV virus. In the treatment of CHB, Antiviral drugs can not only achieve long-term viral suppression for most CHB patients, but also have a positive impact on other CHB treatment goals and improvement of prognosis, but can not eliminate the risk of adverse clinical outcomes completely, which are partly attributed to concomitant diseases such as fatty liver disease (FLD). Both diseases can cause chronic liver injure and increase the risk of cirrhosis and HCC.All patients included in this study underwent liver biopsy to determine their pathological status, ensuring the reliability and accuracy of disease diagnosis. And based on biopsy results, patients were categorized into two groups:fatty liver combined with hepatitis B and hepatitis B alone. The main antiviral treatments used in the study include first-line NAs, such as entecavir, tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), and interferons (IFN-α and Peg-IFN-α). They were followed for five years to thoroughly assess the long-term efficacy of antiviral treatment. Additionally, complications and liver fibrosis were evaluated using ultrasound and FibroScan to monitor the advancement of liver disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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

Primary outcomes

  1. Comparison of virological levels in serum

    Time frame: 5 years

    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.

  2. Comparison of liver function improvement

    Time frame: 5 years

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

Secondary outcomes

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

    Time frame: 5 years

    Evaluation of the incidence of adverse outcomes such as liver cirrhosis, hepatocellular carcinoma (HCC) under ultrasound, and overall survival in CHB patients with fatty liver compared to those without fatty liver.

  2. Factors affecting adverse outcomes in patients with chronic hepatitis B

    Time frame: 5 years

    Kaplan-Meier method was used for survival analysis, and the influencing factors of poor prognosis were analyzed.

Sponsors and collaborators

Lead sponsor

Tianjin Second People's Hospital

Other

Registry information

Official study title

Effect of Fatty Liver on Antiviral Treatment in Patients With Hepatitis B

Acronym: AV-FLCHB

Important dates

Study start
2015
Primary completion
2019
Study completion
2024
First posted
Aug 2, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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