Chronic Hepatitis B
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) HBsAg positive for at least 6 months; (2) positive for HBeAg and negative for anti-HBe; (3) elevation of serum alanine aminotransaminase (ALT) levels above more than 2 time the upper limit of normal (ULN) and less than 10 times ULN or liver histology showing inflammation and necrosis = grade 2, or fibrosis = grade 2; (4) initial selection of PEG-IFN treatment with or without NAs during treatment; (5) the relevant information is complete.
Exclusion criteria
Exclusion criteria: (1) co-infection with HCV, HIV or hepatitis delta virus (HDV); (2) other liver diseases, including autoimmune hepatitis (AIH), alcoholic liver disease (ALD), non-alcoholic fatty liver disease (NAFLD), and schistosomiasis; (3) previous treatment with antiviral drugs for CHB or immunomodulators in past 6 months; (4) decompensated cirrhosis, HCC or other malignant tumors; (5) serious heart, kidney, endocrine, hematopoietic and psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg;serum HBeAg quantitation, seroclearance rate and seroconversion rate;HBV DNA quantitation;liver function;phenotype and function change of immunocyte; | — |
Countries
China
Contacts
Anhui Medical University