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Recruiting

NCT Number: NCT02863757

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

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).

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Up to 20 years

Secondary outcomes

  1. Number of patients with hypertension, obesity, diabetes mellitus, hyperlipidaemia

    Time frame: Up to 20 years

  2. Number of patients with liver transplantation and liver-related death

    Time frame: Up to 20 years

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

    Time frame: Up to 20 years

  4. Occurrence time of liver transplantation and liver-related death from baseline

    Time frame: Up to 20 years

Study contacts

Contact information is provided by the study sponsor or research team.

George Lau, MD

CONTACT

[email protected]

+852 2861 3777

Sponsors and collaborators

Lead sponsor

Humanity and Health Research Centre

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2016
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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