Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-24 @ 4:07 PM
NCT ID:
NCT04625166
Eligibility Criteria:
Inclusion Criteria:
* Patients with chronic hepatitis B:18-80 years old, no gender limit;Patient with chronic hepatitis B was diagnosed by liver histopathological examination;The pathological examination of liver tissue clearly provides G/S classification information. If there is steatosis, classification information is required;Patients without prehepatic ascites;Sign informed consent.
* Patients with MAFLD:18-80 years old, no gender limit;Meet the diagnostic criteria for metabolic-related fatty liver disease:Liver histological examination has liver steatosis,and meet one of the following three criteria,that is, overweight/obesity,type 2 diabetes (T2DM) or abnormal metabolism;Liver histopathological examination provides information on the classification of liver cell steatosis, fibrosis, and inflammation clearly;Patients without prehepatic ascites;Sign informed consent;
* Patients with DILI:18-80 years old, no gender limit;Patients with drug-induced liver injury was diagnosed by liver histological examination;The pathological examination of liver tissue provides G/S classification information clearly,If there is liver cell steatosis, classification information is required;Patients without prehepatic ascites;Sign informed consent;
* Healthy volunteers:Aged 18 to 60,Gender not limited,BMI\<25;No abnormal signs by clinical examination,no fatty liver, No history of chronic liver disease such as hepatitis and liver cirrhosis, no serious gastrointestinal disease;Without metabolic syndrome;There is no history of long-term medication,do not taking any drugs before a month when checking;Did not find the primary lesions of liver, laboratory examination and clinical diagnosis without any liver disease and liver function is normal;Sign the informed consent.
Exclusion Criteria:
* Patients with chronic hepatitis B:Merging other disease caused by chronic liver disease (such as other types of viral hepatitis, drug-induced liver injury, autoimmune liver disease, alcoholic liver disease, metabolic related);Merging other systems' serious illness can't cooperate with elastic imaging checking (such as heart failure, renal failure,mental illness);Patients after liver transplantation;Pregnancy patients.
* Patients with MAFLD:Did/ongoing systemic chemotherapy patients;Patients with hepatic steatosis because of alcoholic liver disease,Viral hepatitis,Drug-induced liver disease,Autoimmune hepatitis or hepatolenticular degeneration et al;Special fatty liver disease cases because of drugs, total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism,Cushing's syndrome,β lipoprotein lack hematic disease,Lipid atrophic diabetes or Mauriac syndrome et al;Merging other systems serious illness can't cooperate with elastic imaging checking(such as heart failure, renal failure,mental illness) ; Patients after liver transplantation;Patients with pregnancy.
* Patients with DILI:Other reasons or combined with other reasons caused liver damage (such as viral hepatitis, autoimmune liver disease, alcoholic liver disease, metabolic related fatty liver disease);The liver local infection and systemic infection;Merging other systems serious illness can't cooperate with elastic imaging checking(such as heart failure, renal failure,mental illness) ; Patients after liver transplantation;Patients with pregnancy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04625166
Study Brief:
Protocol Section:
NCT04625166