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

Recruiting

• Conditions: Chronic Hepatitis B; Nonalcoholic Fatty Liver Disease

• Registration Number: NCT02863757
• Lead Sponsor: Humanity and Health Research Centre

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-01
• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-24
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma	Up to 20 years

Secondary Outcome Measures

Name	Time	Method
Number of patients with liver transplantation and liver-related death	Up to 20 years
Number of patients with hypertension, obesity, diabetes mellitus, hyperlipidaemia	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

Trial Locations

Locations (1)

Humanity and Health GI and Liver Centre; 🇨🇳 Hong Kong, Hong Kong, China