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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
First Posted : February 15, 2012
Last Update Posted : May 8, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Chronic Hepatitis B

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 Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase IV Study of Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B
Study Start Date : February 2012
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Chronic hepatitis B


Outcome Measures

Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples Without DNA
Initially, 30ml of heparinized peripheral blood will be obtained from each subjects. After then, 10ml of heparinized peripheral blood will be additionaly obtained at every 3 months follow-up visit.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic Hepatitis B patients under anti-viral therapy
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533051


Contacts
Contact: Hana Park, MD 02-2228-1931 PHN223@yuhs.ac

Locations
Korea, Republic of
Sang Hoon Ahn Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Hana Park, MD    02-2228-1931    PHN223@yuhs.ac   
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         
Sponsors and Collaborators
Yonsei University
Investigators
Study Chair: Sang Hoon Ahn, MD, PhD Department of Internal Medicine, Yonsei Universtiy College of Medicine
More Information

Responsible Party: Sang Hoon Ahn, Associate Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01533051     History of Changes
Other Study ID Numbers: Quit Anti-viral therapy
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: May 2012

Keywords provided by Sang Hoon Ahn, Yonsei University:
Chronic hepatitis B
Nucleos(t)ide analogue
Antiviral treatment
Korea

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents