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

NCT ID: NCT01533051

Last Updated: 2012-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Chronic Hepatitis B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic hepatitis B

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Sang Hoon Ahn

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang Hoon Ahn, MD, PhD

Role: STUDY_CHAIR

Department of Internal Medicine, Yonsei Universtiy College of Medicine

Locations

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Sang Hoon Ahn

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hana Park, MD

Role: CONTACT

02-2228-1931

Facility Contacts

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Hana Park, MD

Role: primary

02-2228-1931

Other Identifiers

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Quit Anti-viral therapy

Identifier Type: -

Identifier Source: org_study_id

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