Hepatitis B
Conditions
Interventions
IFN-a combined with the NAs-na?ve Group: PEG-IFN a
IFN-a combined with NAs has been previously treated in the group: PEG-IFN a
NAs-na?ve monotherapy group:NAs
NAs has been previously monotherapy group:NAs
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years old, gender is not limited (including 18 and 65 years old) 2. Chronic viral hepatitis B was diagnosed according to the diagnostic criteria for chronic hepatitis B in the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition). 3. Diagnosis of compensated cirrhosis was made according to the diagnostic criteria of the Guidelines for the Prevention and Treatment of Liver Cirrhosis (2019) in compensated liver cirrhosis, and the following settings were set in this study: (1) Liver histopathology: Metavir score = stage 4; (2) Endoscopic esophagogastroscopic varices or ectopic varices of the digestive tract, excluding non-cirrhotic portal hypertension; (3) Transient elastography: usually in the case of normal TBiL and ALT<5 ULN, LSM =17.0 kPa; When TBiL and ALT were normal, LSM =12.0 kPa (4) B-ultrasound and CT imaging examinations showed liver cirrhosis or venous hypertension. For example, the liver light spot is thickened and uneven, hypoechoic/low-density nodules, or the portal inner diameter is widened (=1.3cm), splenomegaly, etc. 4. Receiving pegylated interferon a alone/combined/sequential nucleoside therapy 5. Child grade A
Exclusion criteria
Exclusion criteria: 1. Co-infection with hepatitis A virus, hepatitis C virus or human immunodeficiency virus; 2. Patients with decompensated liver cirrhosis, hepatocellular carcinoma, and liver transplantation; 3. Combined with alcoholic hepatitis, drug-induced hepatitis, autoimmune disease or metabolic liver disease; 4. Those who are pregnant or lactating or have serious diseases of other important organs; 5. Those who are allergic to pegylated interferon a or meet the contraindications of medication;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg negative conversion rate;Liver fibrosis degree stage change value of metavir score;Quantitative value of changes in the size of cirrhosis nodules;Alterations in LSM within transient elastic imaging of the liver;Portal diameter width change quantitative value; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBeAg negative conversion rate or serum conversion rate;HBV DNA negative conversion rate; | — |
Countries
China
Contacts
Public ContactPan Xiucheng
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed