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Trial record 1 of 1 for:    Observational Cohort Study for Durability of antiviral treatment in chronic hepatitis B patients
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Prospective Observational Cohort Study for the Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Yonsei University.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sang Hoon Ahn, Yonsei University
ClinicalTrials.gov Identifier:
NCT01533051
First received: February 7, 2012
Last updated: May 7, 2012
Last verified: May 2012
  Purpose
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
Chronic Hepatitis B

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase IV Study of Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Sustained virological response after stopping anti-viral treatment [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533051

Locations
Korea, Republic of
Sang Hoon Ahn
Seoul, Korea, Republic of, 120-752
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 
Study First Received: February 7, 2012
Last Updated: May 7, 2012
Health Authority: Korea: Institutional Review Board
Korea: Ministry for Health and Welfare

Keywords provided by 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
Hepatitis, Viral, Human
Antiviral Agents
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Anti-Infective Agents

ClinicalTrials.gov processed this record on December 06, 2016