Follow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease

December 19, 2022 updated by: Humanity and Health Research Centre

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).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China, 00852
        • Recruiting
        • Humanity and Health GI and Liver Centre
        • Contact:
        • Principal Investigator:
          • George KK Lau, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hosptials and primary care clinics

Description

Inclusion Criteria:

  • Liver biopsy proved CHB and/or NAFLD at baseline;
  • Chinese
  • Follow-up duration>12 months

Exclusion Criteria:

  • Other liver diseases;
  • Secondary causes of hepatic steatosis;
  • Alcohol abuse;
  • Liver cirrhosis, cirrhosis related complications or HCC at baseline;
  • Malignancy;
  • History of liver transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma
Time Frame: Up to 20 years
Up to 20 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with hypertension, obesity, diabetes mellitus, hyperlipidaemia
Time Frame: Up to 20 years
Up to 20 years
Number of patients with liver transplantation and liver-related death
Time Frame: Up to 20 years
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
Up to 20 years
Occurrence time of liver transplantation and liver-related death from baseline
Time Frame: Up to 20 years
Up to 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanity and Health Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

December 1, 2026

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Actual)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H&H_NAFLD/CHB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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