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

NCT02863757 | Recruiting DMC

• 1 other identifier: H&H_NAFLD/CHB
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Hepatitis B; Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Number of patients with liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma

  Up to 20 years

Secondary Outcomes (4)

• Number of patients with hypertension, obesity, diabetes mellitus, hyperlipidaemia

  Up to 20 years

• Number of patients with liver transplantation and liver-related death

  Up to 20 years

• Diagnosis time of liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma from baseline

  Up to 20 years

• Occurrence time of liver transplantation and liver-related death from baseline

  Up to 20 years

Study Arms (3)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hosptials and primary care clinics

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Humanity and Health Research Centre: lead

Study Sites (1)

Humanity and Health GI and Liver Centre

Hong Kong, Hong Kong, 00852, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatty Liver

Central Study Contacts

George Lau, MD

CONTACT

+852 2861 3777; gkklau@netvigator.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 11, 2016
• Study Start: August 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)