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

May 7, 2012 updated by: Sang Hoon Ahn, Yonsei University

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hana Park, MD
  • Phone Number: 02-2228-1931
  • Email: PHN223@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Sang Hoon Ahn
        • Contact:
        • Sub-Investigator:
          • Kwang-Hyub Han, MD, PhD
        • Sub-Investigator:
          • Do Young Kim, MD, PhD
        • Sub-Investigator:
          • Jun Yong Park, MD
        • Sub-Investigator:
          • Seung Up Kim, MD
        • Sub-Investigator:
          • Hana Park, MD
        • Sub-Investigator:
          • Young Eun Chon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Chronic Hepatitis B patients under anti-viral therapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Chronic hepatitis B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Study Chair: Sang Hoon Ahn, MD, PhD, Department of Internal Medicine, Yonsei Universtiy College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

February 7, 2012

First Submitted That Met QC Criteria

February 14, 2012

First Posted (Estimate)

February 15, 2012

Study Record Updates

Last Update Posted (Estimate)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 7, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Quit Anti-viral therapy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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