Chronic Hepatitis BNCT02263755
Establishment of Retrospective and Prospective Multicenter Cohort for Chronic Hepatitis B
An observational study of Chronic Hepatitis B, run by Yonsei University.
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 20 years and older
- Conditions the study is for
- Chronic Hepatitis B
- How many people
- 476 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2014to 25 Jun 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: outpatient clinic in tertiary hospital
Who may be able to join
- Subject aged 20 years or older
- Subject who has been diagnosed with chronic hepatitis B (HBs Ag (+) for minimum of 6 months_
- Subject who is currently under clinical follow up at the registered institution
- Subject who has undergone or who can undergo liver fibroscan at the time of registration
- Subject who has given informed consent to the enrollment
Who cannot join
- Subject with decompensated liver cirrhosis or hepatocellular carcinoma at the time of initial liver fibroscan
- Subject who had previously undergone antiviral therapy for chronic hepatitis B
- Subject who are concomittantly infected with HCV, HDV or HIV
- Subject with chronic alcoholism defined as equal to or greater than 40g of alcohol for duration of 5 years or longer
- Subject who has been diagnosed with right sided heart failure
- Subjects whose liver fibroscan result is not valid
Show all 9Show fewer
- Subject who is considered ineligible to the enrollment to clinical study by the researcher
- Subjects who is pregnant at the time of registration
- Pregnancy
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 retrospective and 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 500 cases as have been advised by the CDC during the study period (September, 2014-March, 2015) from 4 tertiary hospitals located in Korea. In the past 5 years, there have been about 800 subjects with chronic hepatitis B who have undergone liver fibroscan and liver biopsy from these 4 institutions. The investigators plan to register available cases retrospectively from those who are available to agree to give written informed consent to participate in this study, and to register the remaining numbers of cases prospectively, according to the inclusion and exclusion criteria.
- Conditions
- Chronic Hepatitis B
- Keywords
- CHB, cohort, fibroscan
- 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.
| Study group | Role | What they receive |
|---|---|---|
| chronic hepatitis B subjects | Subjects who have been diagnosed with chronic hepatitis B. |
What is being measured
The primary outcome is the main question the study is designed to answer.
retrospective and prospective multicenter cohort for chronic hepatitis B based on Korean patients
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.)
Measured: time of registration of patient to cohort completment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study start2 Sep 2014
- Primary completion25 Jun 2015
- Study completion25 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Other
- Enrolment
- 476 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kwang Hyub Han, MD,PhD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263755
- Sponsor's protocol ID
- 4-2014-0582
- Status last verified
- Jan 2017
- First submitted
- 3 Sep 2014
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jung KS, Kim SU, Ahn SH, Park YN, Kim DY, Park JY, Chon CY, Choi EH, Han KH. Risk assessment of hepatitis B virus-related hepatocellular carcinoma development using liver stiffness measurement (FibroScan). Hepatology. 2011 Mar;53(3):885-94. doi: 10.1002/hep.24121. Epub 2011 Feb 11.
PubMed 21319193Kim SU, Ahn SH, Park JY, Kang W, Kim DY, Park YN, Chon CY, Han KH. Liver stiffness measurement in combination with noninvasive markers for the improved diagnosis of B-viral liver cirrhosis. J Clin Gastroenterol. 2009 Mar;43(3):267-71. doi: 10.1097/MCG.0b013e31816f212e.
PubMed 18987556Kim SU, Seo YS, Cheong JY, Kim MY, Kim JK, Um SH, Cho SW, Paik SK, Lee KS, Han KH, Ahn SH. Factors that affect the diagnostic accuracy of liver fibrosis measurement by Fibroscan in patients with chronic hepatitis B. Aliment Pharmacol Ther. 2010 Aug;32(3):498-505. doi: 10.1111/j.1365-2036.2010.04353.x. Epub 2010 May 11.
PubMed 20491742
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Retrospective and Prospective Multicenter Cohort for Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT02263755
- Acronym / sponsor ID
- 4-2014-0582
- Conditions
- Chronic Hepatitis B
- Keywords
- CHB, cohort, fibroscan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 476 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Sep 2014 (actual)
- Primary completion
- 25 Jun 2015 (actual)
- Study completion
- 25 Jun 2015 (actual)
- First posted
- 13 Oct 2014 (estimated)
- 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 retrospective and 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 500 cases as have been advised by the CDC during the study period (September, 2014-March, 2015) from 4 tertiary hospitals located in Korea. In the past 5 years, there have been about 800 subjects with chronic hepatitis B who have undergone liver fibroscan and liver biopsy from these 4 institutions. The investigators plan to register available cases retrospectively from those who are available to agree to give written informed consent to participate in this study, and to register the remaining numbers of cases prospectively, according to the inclusion and exclusion criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic hepatitis B subjects | – | –Subjects who have been diagnosed with chronic hepatitis B. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatient clinic in tertiary hospital
Key inclusion criteria (5 listed)
- Subject aged 20 years or older
- Subject who has been diagnosed with chronic hepatitis B (HBs Ag (+) for minimum of 6 months_
- Subject who is currently under clinical follow up at the registered institution
- Subject who has undergone or who can undergo liver fibroscan at the time of registration
- Subject who has given informed consent to the enrollment
Key exclusion criteria (9 listed)
- Subject with decompensated liver cirrhosis or hepatocellular carcinoma at the time of initial liver fibroscan
- Subject who had previously undergone antiviral therapy for chronic hepatitis B
- Subject who are concomittantly infected with HCV, HDV or HIV
- Subject with chronic alcoholism defined as equal to or greater than 40g of alcohol for duration of 5 years or longer
- Subject who has been diagnosed with right sided heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
retrospective and prospective multicenter cohort for chronic hepatitis B based on Korean patients
Time frame: time of registration of patient to cohort completment
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.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Background: PubMed 21319193Jung KS, Kim SU, Ahn SH, Park YN, Kim DY, Park JY, Chon CY, Choi EH, Han KH. Risk assessment of hepatitis B virus-related hepatocellular carcinoma development using liver stiffness measurement (FibroScan). Hepatology. 2011 Mar;53(3):885-94. doi: 10.1002/hep.24121. Epub 2011 Feb 11.
- Background: PubMed 18987556Kim SU, Ahn SH, Park JY, Kang W, Kim DY, Park YN, Chon CY, Han KH. Liver stiffness measurement in combination with noninvasive markers for the improved diagnosis of B-viral liver cirrhosis. J Clin Gastroenterol. 2009 Mar;43(3):267-71. doi: 10.1097/MCG.0b013e31816f212e.
- Background: PubMed 20491742Kim SU, Seo YS, Cheong JY, Kim MY, Kim JK, Um SH, Cho SW, Paik SK, Lee KS, Han KH, Ahn SH. Factors that affect the diagnostic accuracy of liver fibrosis measurement by Fibroscan in patients with chronic hepatitis B. Aliment Pharmacol Ther. 2010 Aug;32(3):498-505. doi: 10.1111/j.1365-2036.2010.04353.x. Epub 2010 May 11.
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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.
Kwang Hyub Han, MD,PhD principal investigator
Yonsei University
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B, run by Yonsei University.
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 9 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: finished, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retrospective and prospective multicenter cohort for chronic hepatitis B based on Korean patients (time frame: time of registration of patient to cohort completment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02263755, which also lists 3 linked publications.
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 Jan 2017.