Chronic viral hepatitis B
Conditions
Interventions
Group A (CHB with NAFLD):Peg IFN-a-2b combined NAs
Group B (CHB with NAFLD):NAs monotherapy
Group C (CHB without NAFLD):Peg IFN-a-2b combined NAs
Group D (CHB without NAFLD):NAs monotherapy
Sponsors
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-65, regardless of gender; 2. Patients with chronic hepatitis B who met the treatment criteria had negative HBeAg, normal ALT (< ULN), and quantitative HBsAg =1500IU/ml; 3. The screening period was consistent with the diagnosis of NAFLD; 4. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating patients. 2. Co-infection with HCV or other viral hepatitis and other chronic liver diseases (except NAFLD). 3. At the inclusion stage, patients had biopsy evidence of NASH, as well as patients with cirrhosis (decompensated or decompensated), liver failure, hepatocellular carcinoma, or any type of malignancy. 4. Patients with severe diseases of heart, brain, kidney, and hematopoietic system or with neoplastic diseases. 5. Complicated with severe mental abnormality, uncontrolled hypertension, diabetes, abnormal thyroid function, etc. 6. Absolute neutrophil count <=0.75×10^9/L and/or platelet <50×10^9/L. 7. Patients who are allergic to interferon, and patients with contraindications in the instructions. 8. Patients with alcoholic fatty liver and mixed fatty liver. 9. Patients evaluated by the researchers as unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| q-HBsAg;Highly sensitive HBV-DNA;HBV-RNA;Clearance Rate of HBsAg at the 48 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver function test;Proportion of HBsAg Decline > 1 lg IU/mL at the 48 weeks;Proportion of HBsAg Decline > 1 lg IU/mL at the 72/96 weeks; | — |
Countries
China
Contacts
Public ContactWang Xiaozhong
Chinese medicine hospital of the xinjiang uygur autonomous region
Outcome results
None listed