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 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 (-). Approximately 140 subjects meeting eligibility criteria will be enrolled a Intervention Arm as below; \- Intervention Arm: 140 subjects, discontinue antiviral treatment (stop group) Participants are scheduled to be followed up to 48 weeks. Patients are 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) at the participant's request or at the treating investigator's discretion, 3) progression to liver cirrhosis, or 4) development of hepatocellular carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
140
discontinue antiviral treatment
Asan Medical Center
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyung-Hee University Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, 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 in 48 weeks
Biochemical relapse
ALT ≥80 U/L with HBV DNA ≥2000 IU/mL
Time frame: From baseline, clinical events will be collected within 48 weeks
ALT flare
ALT ≥200 U/L after documented virological relapse
Time frame: 48 weeks
Retreatment
Retreatment
Time frame: 48 weeks
HBsAg seroclearance
HBsAg seroclearance
Time frame: 48 weeks
Hepatic decompensation
ascites, encephalopathy, variceal bleeding, or jaundice
Time frame: 48 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.