Fatty Liver DiseaseAV-FLCHBNCT06535048
Impact of Fatty Liver on Hepatitis B Therapy
An observational study of Fatty Liver Disease and Chronic Hepatitis B, run by Tianjin Second People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fatty Liver Disease, Chronic Hepatitis B, Antiviral Treatment
- What is being tested?
- Entecavir；Tenofovir Disoproxil Fumarate (TDF)； Tenofovir alafenamide fumarate (TAF)；Interferons
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Effect of Fatty Liver on Antiviral Treatment in Patients With Hepatitis B
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.
Read the detailed description
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.
- Being tested
- Entecavir；Tenofovir Disoproxil Fumarate (TDF)； Tenofovir alafenamide fumarate (TAF)；Interferons
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entecavir；Tenofovir Disoproxil Fumarate (TDF)； Tenofovir alafenamide fumarate (TAF)；InterferonsDrug
Also called Entecavir: Baraclude, Tenofovir Disoproxil Fumarate (TDF): Viread, Tenofovir Alafenamide Fumarate (TAF): Vemlidy, Pegylated Interferon Alpha (Peg-IFN-α): Pegasys
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.
| Study group | Role | What they receive |
|---|---|---|
| Fatty Liver | Hepatitis B patients with fatty liver Receives: Drug: Entecavir；Tenofovir Disoproxil Fumarate (TDF)； Tenofovir alafenamide fumarate (TAF)；Interferons | |
| Non-Fatty Liver | Hepatitis B patients without fatty liver Receives: Drug: Entecavir；Tenofovir Disoproxil Fumarate (TDF)； Tenofovir alafenamide fumarate (TAF)；Interferons |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Comparison of liver function improvement
Liver function was assessed by measuring serum ALT, AST, and GGT levels during treatment.
Measured: 5 years
Secondary outcomes (2)
Impact of Fatty Liver on the Incidence of Adverse Outcomes in CHB Patients
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.
Measured: 5 years
Factors affecting adverse outcomes in patients with chronic hepatitis B
Kaplan-Meier method was used for survival analysis, and the influencing factors of poor prognosis were analyzed.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Jan 2015
- Primary completion30 Jun 2019
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535048
- Sponsor's protocol ID
- AV-FLCHB
- Other IDs
- TJWJ2022XK034, TJYXZDXK-059B
- Acronym
- AV-FLCHB
- Status last verified
- Aug 2024
- First submitted
- 27 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Due to concerns about participant privacy, data security, and the administrative burden of managing data requests, individual participant data (IPD) will not be shared. Additionally, the current research agreement does not include a data sharing clause.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fatty Liver on Antiviral Treatment in Patients With Hepatitis B
- ClinicalTrials.gov ID
- NCT06535048
- Acronym / sponsor ID
- AV-FLCHB / AV-FLCHB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Tianjin Second People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fatty Liver | – | Drug: Entecavir；Tenofovir Disoproxil Fumarate (TDF)； Tenofovir alafenamide fumarate (TAF)；InterferonsHepatitis B patients with fatty liver |
| Non-Fatty Liver | – | Drug: Entecavir；Tenofovir Disoproxil Fumarate (TDF)； Tenofovir alafenamide fumarate (TAF)；InterferonsHepatitis B patients without fatty liver |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entecavir；Tenofovir Disoproxil Fumarate (TDF)； Tenofovir alafenamide fumarate (TAF)；InterferonsAlso: Entecavir: Baraclude, Tenofovir Disoproxil Fumarate (TDF): Viread, Tenofovir Alafenamide Fumarate (TAF): Vemlidy, Pegylated Interferon Alpha (Peg-IFN-α): PegasysEntecavir: 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. | Drug | Fatty Liver, Non-Fatty Liver |
Primary outcome
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.
Comparison of liver function improvement
Time frame: 5 years
Liver function was assessed by measuring serum ALT, AST, and GGT levels during treatment.
2 secondary outcomes
Impact of Fatty Liver on the Incidence of Adverse Outcomes in CHB Patients
Time frame: 5 years
Factors affecting adverse outcomes in patients with chronic hepatitis B
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: No. Due to concerns about participant privacy, data security, and the administrative burden of managing data requests, individual participant data (IPD) will not be shared. Additionally, the current research agreement does not include a data sharing clause.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Liver Disease and Chronic Hepatitis B, run by Tianjin Second People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of virological levels in serum (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.