Prospective Observational Cohort Study for the Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B
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ClinicalTrials.gov Identifier: NCT01533051
Recruitment Status : Unknown
Verified May 2012 by Sang Hoon Ahn, Yonsei University. Recruitment status was: Recruiting
The aim of this study is to investigate the off-treatment sustained virological and biochemical response in chronic hepatitis B patients following the guideline by the Asian Pacific Association for the Study of the Liver (APASL) in Korea.
Condition or disease
Chronic Hepatitis B
In the recommendation by the Asian PAcific Association for the Study of the Liver(APASL), antiviral drug is recommended to stop when HBeAg seroconversion has developed for more than 6 months among HBeAg-positive patietns. For HBeAg-negative patients, the APASL consensus recommended stopping anti-viral treatment when HBV DNA remained undetectable for three separates occasion 6 months apart. Nontheless, approximately 25% to 50% of the patients still develop hepatitis relapse after stopping anti-viral therapy even if these recommendations are followed. In this study, the investigators aimed to investigated the off-treatment sustained response in chronic hepatitis B parients following the stopping anti-viral treatment guideline in Korea.
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Ages Eligible for Study:
20 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Chronic Hepatitis B patients under anti-viral therapy
More than 20 years old
Chronic hepatitis B patients under anti-viral therapy
In HBeAg-positive patient; if HBeAg seroconversion with undetectable HBV DNA is documented on two separate occasions at least 6 months
In HBeAg-negative patient; if undetectable HBV DNA has been documented on three separate occasions 6 months apart
Patients who had chronic liver disease due to hemochromatosis, autoimmune hepatitis, drug-induced hepatitis, or thalassemia
Patients who suffered from other chronic medical condition