Status:
COMPLETED
Steatohepatitis in Chronic Hepatitis B
Lead Sponsor:
Mahidol University
Conditions:
Fatty Liver
Chronic Hepatitis b
Eligibility:
All Genders
18+ years
Brief Summary
Fatty liver disease is increasingly recognized in patients with chronic hepatitis B (CHB). Whether concurrent fatty liver disease affects the long-term outcomes of CHB is unclear. The investigators pe...
Detailed Description
Chronic hepatitis B virus (HBV) infection is a global public health problem affecting more than 250 million people at high risk of death from cirrhosis and liver cancer. The goal of therapy for patien...
Eligibility Criteria
Inclusion
- All CHB patients who had significant histologic features, defined as at least moderate necroinflammation and/or liver fibrosis stage 2 or higher according to the METAVIR system, required antiviral therapy and have been managed in our institution.
- HBV-treated patients who had achieved undetectable HBV DNA or hepatitis B surface antigen (HBsAg) loss during antiviral therapy, and those who had hepatitis B e antigen (HBeAg) seroconversion with serum HBV DNA persistently \<2,000 IU/ml and normalization of aminotransferase levels after discontinuing antiviral therapy.
Exclusion
- Patients who had viremia \>2000 IU/ml after stopping antiviral agents will be excluded.
- Patients with a history of alcohol dependence or co-infections with hepatitis C virus or human immunodeficiency virus before liver biopsy will be excluded.
Key Trial Info
Start Date :
January 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT05317260
Start Date
January 1 2002
End Date
December 31 2021
Last Update
April 7 2022
Active Locations (1)
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1
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700