Hepatitis B, ChronicHBHSNCT02392598
A Hepatitis B With Hepatic Steatosis Study
An observational study of Hepatitis B, Chronic and Hepatic Steatosis, run by Fatty Liver and Alcoholic Liver Disease Study Group, China at 7 sites in China.
Trial summary
This is an epidemiologic study on effect of hepatic steatosis on prognosis and outcomes of patients with chronic hepatitis B. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis B, Chronic, Hepatic Steatosis
- How many people
- 3,000 participants
- Where
- 7 sitesChina
- Study dates
- Aug 2015to Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patients with chronic hepatisis B meeting eligibility criteria
Who may be able to join
- Clinically diagnosed chronic hepatitis B.
- Specific biopsy requirements for hepatic steatosis: qualified biopsy specimen within 6 months, >5% hepatocytes show macrovesicular steatosis under HE staining and X10 microscope.
- Willing to participate in the long-term follow-up and cooperative.
- Able to provide informed consent file.
Who cannot join
- Unable to provide informed consent.
- Patients are eligible for baseline analysis but not eligible for follow-up, if having any of the following condition:
- Any end-stage liver disease.
- Any malignant tumor.
- Any congenital liver disease such as Wilson disease.
- Any other serious disease of projected survival < 5 years.
Trial locations and contacts
7 sites in 1 country.
Jiangao Fan, MD contact
Shiyan Yan, MD contact
7 sites in 1 country
China7 sites
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan
Liangping Li, MD
Liangping Li, MD
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang
Junping Shi, MD
Junping Shi, MD
Shandong Provincial Hospital
Ji'nan, Shandong
Wanhua Ren, MD
Wanhua Ren, MD
Shanghai Xinhua Hospital
Shanghai
Jiangao Fan, MD, fattyliver2004@126.com
Tianjin Second People's Hospital
Tianjin, Tianjin Municipality
Yuqiang Mi, MD
Yuqiang Mi, MD
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Fangping He, MD
Fangping He, MD
Zhangzhou Zhengxing Hospital
Zhangzhou, Fujian
Ruidan Zheng, MD
Ruidan Zheng, MD
About this study
Official title: Effect of Hepatic Steatosis on Prognosis and Outcomes of Patients With Chronic Hepatitis B
This is an epidemiologic study on effect of hepatic steatosis on prognosis and outcomes of patients with chronic hepatitis B.
Read the detailed description
This is a multicenter, prospective and open-enrollment epidemiologic study. All the patients with chronic hepatisis B will be enrolled in the study and followed up after 1 year, 3 years and 5 years with a visit window of +1 month.
- Conditions
- Hepatitis B, Chronic, Hepatic Steatosis
- Medical subject headings
- Hepatitis B, Chronic, Fatty Liver
What is being measured
The primary outcome is the main question the study is designed to answer.
liver cirrhosis
Measured: 5 years
Secondary outcomes (8)
liver cancer
Measured: 5 years
liver failure
Measured: 5 years
type 2 diabetes
Measured: 5 years
cardiovascular and cerebrovascular events
Measured: 5 years
death
Measured: 5 years
response of hepatic steatosis to anti-virus treatment
Measured: 1 year
effect of hepatic steatosis on HBeAg negativation among patients without anti-virus treatment
Measured: 1 year
effect of hepatic steatosis on HBsAg negativation among patients without anti-virus treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatty Liver and Alcoholic Liver Disease Study Group, China
- Sponsor type
- University, hospital or other
- Collaborators
- Unimed Scientific Inc.
- Responsible party
- Sponsor
- Investigators
- Jiangao Fan, MD, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392598
- Sponsor's protocol ID
- HBV2015
- Acronym
- HBHS
- Status last verified
- Aug 2015
- First submitted
- 13 Mar 2015
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hepatic Steatosis on Prognosis and Outcomes of Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT02392598
- Acronym / sponsor ID
- HBHS / HBV2015
- Conditions
- Hepatitis B, Chronic, Hepatic Steatosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Fatty Liver and Alcoholic Liver Disease Study Group, ChinaUniversity, hospital or other
- Collaborators
- Unimed Scientific Inc.
- Study start
- Aug 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 19 Mar 2015 (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.
This is an epidemiologic study on effect of hepatic steatosis on prognosis and outcomes of patients with chronic hepatitis B.
Detailed description
This is a multicenter, prospective and open-enrollment epidemiologic study. All the patients with chronic hepatisis B will be enrolled in the study and followed up after 1 year, 3 years and 5 years with a visit window of +1 month.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patients with chronic hepatisis B meeting eligibility criteria
Key inclusion criteria (4 listed)
- Clinically diagnosed chronic hepatitis B.
- Specific biopsy requirements for hepatic steatosis: qualified biopsy specimen within 6 months, >5% hepatocytes show macrovesicular steatosis under HE staining and X10 microscope.
- Willing to participate in the long-term follow-up and cooperative.
- Able to provide informed consent file.
Key exclusion criteria (6 listed)
- Unable to provide informed consent.
- Patients are eligible for baseline analysis but not eligible for follow-up, if having any of the following condition:
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
liver cirrhosis
Time frame: 5 years
8 secondary outcomes
liver cancer
Time frame: 5 years
liver failure
Time frame: 5 years
type 2 diabetes
Time frame: 5 years
cardiovascular and cerebrovascular events
Time frame: 5 years
death
Time frame: 5 years
response of hepatic steatosis to anti-virus treatment
Time frame: 1 year
effect of hepatic steatosis on HBeAg negativation among patients without anti-virus treatment
Time frame: 1 year
effect of hepatic steatosis on HBsAg negativation among patients without anti-virus treatment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
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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.
Jiangao Fan, MD contact
Shiyan Yan, MD contact
Jiangao Fan, MD principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, Chronic and Hepatic Steatosis, run by Fatty Liver and Alcoholic Liver Disease Study Group, China at 7 sites in China.
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 4 inclusion and 6 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 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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 Jiangao Fan, MD (fattyliver2004@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver cirrhosis (time frame: 5 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 5 Aug 2015.