Multicenter, Prospective Open-label Single Arm Trial Chronic hepatitis B male and female adults on antiviral treatment for hepatitis B, without cirrhosis who are currently HBV DNA (-) and HBeAg (-) To evaluate the safety and efficacy of stopping long-term antiviral therapy in chronic hepatitis B patients without cirrhosis who are currently HBV DNA (-) and HBeAg (-)
This clinical trial is a multicenter, Prospective Open-label Single Arm Trial to compare the short-term clinical outcome between stopping and continuing antiviral treatment in chronic hepatitis B patients without cirrhosis who are currently HBV DNA (-) and HBeAg (-) Approximately 140 subjects meeting eligibility criteria will be enrolled a Intervention Arm as below; * Intervention Arm: 140 subjects, discontinue antiviral treatment (stop group) * Historical cohort: 700 subjects, continue antiviral treatment Stop group is scheduled to be followed up to 12months. Patients in the stop group were retreated with nucleos(t)ide analogues that had been prescribed previously if they fulfill one of the following criteria: 1) HBV DNA \>2,000 IU/mL, 2) progression to liver cirrhosis, or 3) development of hepatocellular carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
140
discontinue antiviral treatment
Kyungpook National University Hospital
Daegu, South Korea
Asan Medical Center
Seoul, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Konkuk University Hospital
Seoul, South Korea
virological relapse
Proportion of virological relapse defined as HBV DNA ≥2,000 IU/mL
Time frame: Change from baseline in HBV DNA result at 6month and 12month
hospital admission
Proportion of liver-related unexpected hospital admission
Time frame: From baseline, clinical events will be collected within 12month
Proportion of clinical relapse
Proportion of clinical relapse (HBV DNA ≥2,000 IU/mL and ALT ≥80 IU/mL)
Time frame: at 6month and 12 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Korea University Guro Hospital
Seoul, South Korea
Kyung-Hee University Hospital
Seoul, South Korea
Samsung Medical center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea