Chronic Hepatitis BNCT04139850
The Establishment of Korean Hepatitis B Patients Cohort
An observational study of Chronic Hepatitis B, run by Yonsei University at 1 site in South Korea.
Trial summary
According to the World Health Organization about 1,400,000 deaths reported annually, are related to chronic liver disease. Chronic liver disease is very prevalent in South Korea, placing a large economic burden nationwide. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Discontinuation of antiviral treatment in chronic hepatitis B cohort patients
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Sep 2015to Aug 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient clinic in tertiary hospitals
Who may be able to join
- age above 19 years;
- CHB diagnosis with more than 6 months of HBsAg positive;
- Patients who followed up regularly by medical institutions due to CHB;
- Patients who can be followed up according to the research protocol;
- Patients who have consented to the written consent of the applicant or guardian.
Who cannot join
- HCC diagnosis before enrollment;
- Malignant tumor other than HCC within 5 years;
- Hepatitis C virus or human immunodeficiency virus co-infection;
- Fatal conditions such as decompensated liver function, end stage renal disease and severe heart failure;
- not be suitable for the research purpose.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 120-752
Sang Hoon Ahn, MD, +82-2-2228-1936, ahnsh@yuhs.ac
About this study
According to the World Health Organization about 1,400,000 deaths reported annually, are related to chronic liver disease. Chronic liver disease is very prevalent in South Korea, placing a large economic burden nationwide. Subsequently, an effective and systematized approach to managing chronic hepatitis is imperative in Korea.
The natural history of chronic liver disease differs greatly according to race and ethnicity. However, there is scarcity of epidemic data on chronic hepatitis based on Korean patients. Therefore, the investigators plan to establish a prospective multicenter cohort for chronic hepatitis B based on Korean patients that may be utilized for various future clinical studies on chronic hepatitis B in Korea, and thereby serve as a basis for the establishment and distribution of clinical guidelines for Korean patients with chronic hepatitis B, as part of a nationwide project supported by the Centers for Disease Control (CDC), Korea.
The investigators plan to collect more than 2,000 cases per year with 6 months of regular follow-up interval as have been advised by the CDC during 10 years of the study period (from Sep. 2015) from 5 tertiary hospitals located in Korea. The investigators plan to register available cases from those who are available to agree to give written informed consent and provide their blood samples to participate in this study prospectively, according to the inclusion and exclusion criteria.
- Conditions
- Chronic Hepatitis B
- Being tested
- Discontinuation of antiviral treatment in chronic hepatitis B cohort patients
- Keywords
- chronic hepatitis B, cohort, nationwide, prospective, antiviral therapy
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of antiviral treatment in chronic hepatitis B cohort patientsDrug
For the selective patients in the cohort with long-term antiviral therapy and with conditions such as HBeAg negative or loss more than one year, antiviral therapy is able to be discontinued with an intensive inspection who agreed to the process. If there are need of this intervention, another multicenter IRB approval will be taken.
| Study group | Role | What they receive |
|---|---|---|
| Korean chronic hepatitis B patients cohort | Korean patients with chronic hepatitis B with or without antiviral therapy on a regular follow-up in tertially medical institution Receives: Drug: Discontinuation of antiviral treatment in chronic hepatitis B cohort patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of liver cirrhosis, decompensation or liver cancer
This study aims for the establishment of chronic hepatitis B cohort and has no other primary end point other than the registration of the patient. (For Time-to-Event outcome measures, the development of events including HCC, ascitic decompensation, variceal bleeding, hepatic encephalopathy, transplantation, and death will be followed up to 10 years after enrollment. Time to the development of each kind of event will be calculated from the date of enrollment and the respective date of event development.) Safety issue: No
Measured: Time of registration of patient to cohort complement (10 years)
Secondary outcomes (1)
Safety and efficacy for patients with or without antiviral therapy
Virologic response, HBsAg loss or seroconversion, development of resistance to medication, side effect with or without antiviral therapy Virologic breakthrough/development of liver cirrhosis, decompensation or HCC after discontinuation of antiviral therapy
Measured: Time of registration of patient to cohort complement (10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start25 Sep 2015
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139850
- Sponsor's protocol ID
- 4-2015-0748
- Status last verified
- Oct 2019
- First submitted
- 23 Oct 2019
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The patients' clinical and laboratory information are stored in the Korean CDC database as a form of eCRF, then be locked after data cleaning. The sharing data will be coded and won't include patients' sensitive individual information such as a unit-ID and name. The coded data and saved samples will be provided for the guaranteed researchers by the government after confirmation of the relevance of their clinical and basic researches plan related with HBV, during the study and after the study ends.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Establishment of Korean Hepatitis B Patients Cohort
- ClinicalTrials.gov ID
- NCT04139850
- Acronym / sponsor ID
- 4-2015-0748
- Conditions
- Chronic Hepatitis B
- Keywords
- chronic hepatitis B, cohort, nationwide, prospective, antiviral therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 25 Sep 2015 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
According to the World Health Organization about 1,400,000 deaths reported annually, are related to chronic liver disease. Chronic liver disease is very prevalent in South Korea, placing a large economic burden nationwide. Subsequently, an effective and systematized approach to managing chronic hepatitis is imperative in Korea.
The natural history of chronic liver disease differs greatly according to race and ethnicity. However, there is scarcity of epidemic data on chronic hepatitis based on Korean patients. Therefore, the investigators plan to establish a prospective multicenter cohort for chronic hepatitis B based on Korean patients that may be utilized for various future clinical studies on chronic hepatitis B in Korea, and thereby serve as a basis for the establishment and distribution of clinical guidelines for Korean patients with chronic hepatitis B, as part of a nationwide project supported by the Centers for Disease Control (CDC), Korea.
The investigators plan to collect more than 2,000 cases per year with 6 months of regular follow-up interval as have been advised by the CDC during 10 years of the study period (from Sep. 2015) from 5 tertiary hospitals located in Korea. The investigators plan to register available cases from those who are available to agree to give written informed consent and provide their blood samples to participate in this study prospectively, according to the inclusion and exclusion criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Korean chronic hepatitis B patients cohort | – | Drug: Discontinuation of antiviral treatment in chronic hepatitis B cohort patientsKorean patients with chronic hepatitis B with or without antiviral therapy on a regular follow-up in tertially medical institution |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient clinic in tertiary hospitals
Key inclusion criteria (5 listed)
- age above 19 years;
- CHB diagnosis with more than 6 months of HBsAg positive;
- Patients who followed up regularly by medical institutions due to CHB;
- Patients who can be followed up according to the research protocol;
- Patients who have consented to the written consent of the applicant or guardian.
Key exclusion criteria (5 listed)
- HCC diagnosis before enrollment;
- Malignant tumor other than HCC within 5 years;
- Hepatitis C virus or human immunodeficiency virus co-infection;
- Fatal conditions such as decompensated liver function, end stage renal disease and severe heart failure;
- not be suitable for the research purpose.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinuation of antiviral treatment in chronic hepatitis B cohort patientsFor the selective patients in the cohort with long-term antiviral therapy and with conditions such as HBeAg negative or loss more than one year, antiviral therapy is able to be discontinued with an intensive inspection who agreed to the process. If there are need of this intervention, another multicenter IRB approval will be taken. | Drug | Korean chronic hepatitis B patients cohort |
Primary outcome
Development of liver cirrhosis, decompensation or liver cancer
Time frame: Time of registration of patient to cohort complement (10 years)
This study aims for the establishment of chronic hepatitis B cohort and has no other primary end point other than the registration of the patient. (For Time-to-Event outcome measures, the development of events including HCC, ascitic decompensation, variceal bleeding, hepatic encephalopathy, transplantation, and death will be followed up to 10 years after enrollment. Time to the development of each kind of event will be calculated from the date of enrollment and the respective date of event development.) Safety issue: No
1 secondary outcome
Safety and efficacy for patients with or without antiviral therapy
Time frame: Time of registration of patient to cohort complement (10 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Individual participant dataSharing planned: Yes. The patients' clinical and laboratory information are stored in the Korean CDC database as a form of eCRF, then be locked after data cleaning. The sharing data will be coded and won't include patients' sensitive individual information such as a unit-ID and name. The coded data and saved samples will be provided for the guaranteed researchers by the government after confirmation of the relevance of their clinical and basic researches plan related with HBV, during the study and after the study ends.
Related trials for Chronic Hepatitis B
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Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang Hoon Ahn (+82-2-2228-1936, ahnsh@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of liver cirrhosis, decompensation or liver cancer (time frame: Time of registration of patient to cohort complement (10 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019; AzTrials last refreshed its copy on 8 Nov 2026.