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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

This study is currently recruiting participants.
Verified May 2012 by Yonsei University
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
History of Changes

February 7, 2012
May 7, 2012
February 2012
March 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01533051 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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.
Probability Sample

Chronic Hepatitis B patients under anti-viral therapy
Chronic Hepatitis B
Not Provided
Chronic hepatitis B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2016
March 2015   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact: Hana Park, MD 02-2228-1931 PHN223@yuhs.ac
Korea, Republic of
 
NCT01533051
Quit Anti-viral therapy
Yes
Sang Hoon Ahn, Yonsei University
Yonsei University
Not Provided
Study Chair: Sang Hoon Ahn, MD, PhD Department of Internal Medicine, Yonsei Universtiy College of Medicine
Yonsei University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP