Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535048
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-27
Brief Title:
Impact of Fatty Liver on Hepatitis B Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Fatty Liver on Antiviral Treatment in Patients With Hepatitis B
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AV-FLCHB
Brief Summary:
The primary goal of treating chronic hepatitis BCHB 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 peoples health As of 2019 approximately 296 million people 39 of the worlds 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 HCCAll 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 groupsfatty 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None