Recruiting NCT02863757
Follow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Hepatitis B, Nonalcoholic Fatty Liver Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Disease Progression and Clinical Outcomes in Chronic Hepatitis B (CHB) Patients With Comorbid Nonalcoholic Fatty Liver Disease (NAFLD)
Overview
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).
Primary outcome measures
- Number of patients with liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma [Time frame: Up to 20 years]
Secondary outcome measures (4)
- Number of patients with hypertension, obesity, diabetes mellitus, hyperlipidaemia [Time frame: Up to 20 years]
- Number of patients with liver transplantation and liver-related death [Time frame: 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]
- Occurrence time of liver transplantation and liver-related death from baseline [Time frame: Up to 20 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Humanity and Health GI and Liver Centre — Hong Kong
Identifiers
NCT: NCT02863757 · H&H_NAFLD/CHB