Phase IV Study of Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Hepatitis B
- Sponsor
- Yonsei University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Sustained virological response after stopping anti-viral treatment
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Sang Hoon Ahn
Associate Professor
Yonsei University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Patients who had chronic liver disease due to hemochromatosis, autoimmune hepatitis, drug-induced hepatitis, or thalassemia
- •Patients who suffered from other chronic medical condition
Outcomes
Primary Outcomes
Sustained virological response after stopping anti-viral treatment
Time Frame: Up to 3 years
The proportion of patients with sustained virological response after stopping anti-viral treatment