Follow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHumanity and Health Research Centre
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Liver biopsy proved CHB and/or NAFLD at baseline;
Chinese
Follow-up duration>12 months
Disqualifiers
Other liver diseases;
Secondary causes of hepatic steatosis;
Alcohol abuse;
Liver cirrhosis, cirrhosis related complications or HCC at baseline;
Trial population
Hosptials and primary care clinics
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
1,500 Participants
are grouped into 3 trial groupsGroup A: CHB Group
Group B: CHB/NAFLD Group
Group C: NAFLD Group
Trial outcomes
Primary outcomes
1
Number of patients with liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma
Time frame
Up to 20 yearsSecondary outcomes
1
Number of patients with hypertension, obesity, diabetes mellitus, hyperlipidaemia
Time frame
Up to 20 years2
Number of patients with liver transplantation and liver-related death
Time frame
Up to 20 years3
Diagnosis time of liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma from baseline
Time frame
Up to 20 years4
Occurrence time of liver transplantation and liver-related death from baseline
Time frame
Up to 20 yearsSponsors and contacts
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Source ClinicalTrials.gov