Chronic Hepatitis BNCT02031913
Prospective Cohort Study of Association of Insulin Resistance/Steatosis With Hepatic Fibrosis in CHB and NAFLD
An observational study of Chronic Hepatitis B and Hepatic Fibrosis, run by Seoul National University Boramae Hospital at 1 site in South Korea.
Trial summary
Hepatic steatosis and insulin resistance are associated with severity of fibrosis in non-alcoholic fatty liver disease (NAFLD) and chronic hepatitis C. However, clinical significance of steatosis and insulin resistance on fibrosis in chronic hepatitis B (CHB) is not well established. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Hepatitis B, Hepatic Fibrosis, Fatty Liver
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Dec 2022
- How long will I take part?
- 20 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic hepatitis B patients who showed evidences of hepatic steatosis on ultrasonography
Who may be able to join
- Chronic hepatitis B patients
- With evidences of hepatic steatosis on ultrasonography or pathology
Who cannot join
- significant alcohol consumption or other known liver diseases
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Government Seoul National University
Seoul, 156-707
About this study
Official title: Association Between Insulin Resistance and Hepatic Fibrosis in Combined Chronic Hepatitis B and Non-alcoholic Fatty Liver Disease
Hepatic steatosis and insulin resistance are associated with severity of fibrosis in non-alcoholic fatty liver disease (NAFLD) and chronic hepatitis C. However, clinical significance of steatosis and insulin resistance on fibrosis in chronic hepatitis B (CHB) is not well established. The aim was to investigate the relationship between insulin resistance, hepatic steatosis, and fibrosis in patients with CHB.
Read the detailed description
acoustic radiation force impulse elastography
- Conditions
- Chronic Hepatitis B, Hepatic Fibrosis, Fatty Liver
- Keywords
- Chronic hepatitis B, Hepatic fibrosis, Steatosis
- Medical subject headings
- Hepatitis B, Chronic, Liver Cirrhosis, Fatty Liver
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 |
|---|---|---|
| HBV without FL | Chronic hepatitis B without steatosis | |
| HBV with FL | Chronic hepatitis B patients with steatosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance and fibrosis indices
Measurement for insulin resistance and fibrosis index for hepatic fibrosis assessment
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionNov 2022
- Study completionDec 2022
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.
- 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
- 500 participants (actual)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Boramae Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Kim, Seoul National University Boramae Hospital
- Investigators
- Won Kim, Professor, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031913
- Sponsor's protocol ID
- HBV_FL
- Status last verified
- Apr 2023
- First submitted
- 8 Jan 2014
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Insulin Resistance and Hepatic Fibrosis in Combined Chronic Hepatitis B and Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT02031913
- Acronym / sponsor ID
- HBV_FL
- Conditions
- Chronic Hepatitis B, Hepatic Fibrosis, Fatty Liver
- Keywords
- Chronic hepatitis B, Hepatic fibrosis, Steatosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Seoul National University Boramae HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Nov 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 9 Jan 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.
Hepatic steatosis and insulin resistance are associated with severity of fibrosis in non-alcoholic fatty liver disease (NAFLD) and chronic hepatitis C. However, clinical significance of steatosis and insulin resistance on fibrosis in chronic hepatitis B (CHB) is not well established. The aim was to investigate the relationship between insulin resistance, hepatic steatosis, and fibrosis in patients with CHB.
Detailed description
acoustic radiation force impulse elastography
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBV without FL | – | –Chronic hepatitis B without steatosis |
| HBV with FL | – | –Chronic hepatitis B patients with steatosis |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic hepatitis B patients who showed evidences of hepatic steatosis on ultrasonography
Key inclusion criteria (2 listed)
- Chronic hepatitis B patients
- With evidences of hepatic steatosis on ultrasonography or pathology
Key exclusion criteria (1 listed)
- significant alcohol consumption or other known liver diseases
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
Insulin resistance and fibrosis indices
Time frame: one year
Measurement for insulin resistance and fibrosis index for hepatic fibrosis assessment
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 12 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Chronic Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
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.
Won Kim, Professor principal investigator
SMG-SNU Boramae Medical Center
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 and Hepatic Fibrosis, run by Seoul National University Boramae Hospital 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 2 inclusion and 1 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 12 Apr 2023. 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?
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?
Insulin resistance and fibrosis indices (time frame: one year). 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 12 Apr 2023.