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

Chronic Hepatitis B Clinical Trial

Official title:

Disease Progression and Clinical Outcomes in Chronic Hepatitis B (CHB) Patients With Comorbid Nonalcoholic Fatty Liver Disease (NAFLD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02863757
• Other study ID #: H&H_NAFLD/CHB
• Status: Recruiting
• Start date: August 2016
• Est. completion date: December 2026

Study information

• Verified date: December 2022
• Source: Humanity and Health Research Centre
• Contact: George Lau, MD
• Phone: +852 2861 3777
• Email: gkklau[@]netvigator.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Fatty Liver
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Locations

Country	Name	City	State
China	Humanity and Health GI and Liver Centre	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Humanity and Health Research Centre

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma		Up to 20 years
Secondary	Number of patients with hypertension, obesity, diabetes mellitus, hyperlipidaemia		Up to 20 years
Secondary	Number of patients with liver transplantation and liver-related death		Up to 20 years
Secondary	Diagnosis time of liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma from baseline		Up to 20 years
Secondary	Occurrence time of liver transplantation and liver-related death from baseline		Up to 20 years