Chronic Hepatitis BNCT02863757
Follow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease
An observational study of Chronic Hepatitis B and Nonalcoholic Fatty Liver Disease, run by Humanity and Health Research Centre at 1 site in China.
Trial summary
The purpose of this study is to determine the disease progression in CHB/NAFLD compared with CHB and NAFLD including liver cirrhosis, cirrhotic complications and hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Hepatitis B, Nonalcoholic Fatty Liver Disease
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2016to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Hosptials and primary care clinics
Who may be able to join
- Liver biopsy proved CHB and/or NAFLD at baseline;
- Chinese
- Follow-up duration>12 months
Who cannot join
- Other liver diseases;
- Secondary causes of hepatic steatosis;
- Alcohol abuse;
- Liver cirrhosis, cirrhosis related complications or HCC at baseline;
- Malignancy;
- History of liver transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Humanity and Health GI and Liver Centre
Hong Kong, Hong Kong, 00852
George KK Lau, MD, (852)28613777, gkklau@netvigator.com
George KK Lau, MD
About this study
Official title: Disease Progression and Clinical Outcomes in Chronic Hepatitis B (CHB) Patients With Comorbid Nonalcoholic Fatty Liver Disease (NAFLD)
The purpose of this study is to determine the disease progression in CHB/NAFLD compared with CHB and NAFLD including liver cirrhosis, cirrhotic complications and hepatocellular carcinoma (HCC).
- Medical subject headings
- Hepatitis B, Chronic, Non-alcoholic Fatty Liver Disease
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 |
|---|---|---|
| CHB Group | Patients with chronic hepatitis B | |
| CHB/NAFLD Group | Patients with chronic hepatitis B and comorbid nonalcoholic fatty liver disease | |
| NAFLD Group | Patients with nonalcoholic fatty liver disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma
Measured: Up to 20 years
Secondary outcomes (4)
Number of patients with hypertension, obesity, diabetes mellitus, hyperlipidaemia
Measured: Up to 20 years
Number of patients with liver transplantation and liver-related death
Measured: Up to 20 years
Diagnosis time of liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma from baseline
Measured: Up to 20 years
Occurrence time of liver transplantation and liver-related death from baseline
Measured: Up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start1 Aug 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 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.
- 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
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humanity and Health Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863757
- Sponsor's protocol ID
- H&H_NAFLD/CHB
- Status last verified
- Jul 2026
- First submitted
- 4 Aug 2016
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Progression and Clinical Outcomes in Chronic Hepatitis B (CHB) Patients With Comorbid Nonalcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT02863757
- Acronym / sponsor ID
- H&H_NAFLD/CHB
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Humanity and Health Research CentreUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Aug 2016 (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.
The purpose of this study is to determine the disease progression in CHB/NAFLD compared with CHB and NAFLD including liver cirrhosis, cirrhotic complications and hepatocellular carcinoma (HCC).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHB Group | – | –Patients with chronic hepatitis B |
| CHB/NAFLD Group | – | –Patients with chronic hepatitis B and comorbid nonalcoholic fatty liver disease |
| NAFLD Group | – | –Patients with nonalcoholic fatty liver disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hosptials and primary care clinics
Key inclusion criteria (3 listed)
- Liver biopsy proved CHB and/or NAFLD at baseline;
- Chinese
- Follow-up duration>12 months
Key exclusion criteria (6 listed)
- Other liver diseases;
- Secondary causes of hepatic steatosis;
- Alcohol abuse;
- Liver cirrhosis, cirrhosis related complications or HCC at baseline;
- Malignancy;
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
Number of patients with liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma
Time frame: Up to 20 years
4 secondary outcomes
Number of patients with hypertension, obesity, diabetes mellitus, hyperlipidaemia
Time frame: Up to 20 years
Number of patients with liver transplantation and liver-related death
Time frame: Up to 20 years
Diagnosis time of liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma from baseline
Time frame: Up to 20 years
Occurrence time of liver transplantation and liver-related death from baseline
Time frame: Up to 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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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.
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 Nonalcoholic Fatty Liver Disease, run by Humanity and Health Research Centre at 1 site 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 3 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: looking for participants now, as of the sponsor's last update on 29 Jul 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact George Lau, MD (+852 2861 3777, gkklau@netvigator.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma (time frame: Up to 20 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 29 Jul 2026.