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Status unknownNCT01533051Updated May 8, 2012

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

An observational study in Chronic Hepatitis B, sponsored by Yonsei University. Status unknown at 1 site in South Korea. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-05-08.

Sponsored by Yonsei University · Observational

The sponsor has not verified this record recently (last verified May 2012), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Hepatitis B

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Keywords

  • Chronic hepatitis B
  • Nucleos(t)ide analogue
  • Antiviral treatment
  • Korea
03

In context

Hepatitis B, Chronic

954 studies on the registry are indexed under Hepatitis B, Chronic; 147 are open to participants now.

This study's planned enrollment of 100 is below the median of 400 across 229 observational studies indexed under Hepatitis B, Chronic.

Browse Hepatitis B, Chronic studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Chronic Hepatitis B patients under anti-viral therapy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Chronic hepatitis B
06

What researchers measure

Primary outcomes

  1. Sustained virological response after stopping anti-viral treatment

    The proportion of patients with sustained virological response after stopping anti-viral treatment

    Time frame: Up to 3 years

07

Study locations

1 of 1 sites recruiting
  • Sang Hoon Ahn
    Seoul, 120-752, South Korea
    • Hana Park, MD · Contact · PHN223@yuhs.ac · 02-2228-1931
    • 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 · Sub investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2012, a primary completion of Mar 2015 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2012
First posted
Feb 15, 2012
Start
Feb 2012
Primary completionEst.
Mar 2015
CompletionEst.
Mar 2016
Last update
May 8, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01533051
Lead sponsor
Yonsei University
Responsible party
Sang Hoon Ahn (Associate Professor, Yonsei University) — Principal investigator
First posted
Feb 15, 2012
Start date
Feb 2012
Primary completion
Mar 2015 (estimated)
Completion
Mar 2016 (estimated)
Last update
May 8, 2012

Study contacts

Hana Park, MD
Contact
PHN223@yuhs.ac
02-2228-1931
Sang Hoon Ahn, MD, PhD
study chair · Department of Internal Medicine, Yonsei Universtiy College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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