Prospective Observational Cohort Study for the Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B

Phase IV Study of Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01533051

Enrollment

100

Registered

2012-02-15

Start date

2012-02-29

Completion date

2016-03-31

Last updated

2012-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

Chronic hepatitis B, Nucleos(t)ide analogue, Antiviral treatment, Korea

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* More than 20 years old * Chronic hepatitis B patients under anti-viral therapy 1. In HBeAg-positive patient; if HBeAg seroconversion with undetectable HBV DNA is documented on two separate occasions at least 6 months 2. 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

Design outcomes

Primary

Measure	Time frame	Description
Sustained virological response after stopping anti-viral treatment	Up to 3 years	The proportion of patients with sustained virological response after stopping anti-viral treatment

Countries

South Korea

Contacts

Primary ContactHana Park, MD

PHN223@yuhs.ac02-2228-1931

Outcome results