Chronic Hepatitis b
Conditions
Keywords
chronic hepatitis b, peginterferon alfa-2b, interferon gene mutation, interferon receptor
Brief summary
The study is to observe the anti-HBV therapeutic effects of peginterferon alfa-2b in chronic hepatitis b patients with e antigen positive based on the detection of interferon gene mutation (IFNA2 p.Ala120Thr) and interferon receptor (IFNAR2) detection.
Detailed description
Patients with e antigen positive chronic hepatitis b were enrolled in the study. Age, sex, symptoms (e.g., fever, fatigue, poor appetite, jaundice) were recorded in the study. We also observed the laboratory test results including the levels of white blood cells (WBC), red blood cells (RBC), hemoglobin (HGB), platelet (PLT), alanine transaminase (ALT), aspartate transaminase (AST), hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B e antibody (HBeAb), and hepatitis B virus (HBV) DNA; detection of gene mutation (IFNA2 p.Ala120Thr), levels of interferon receptor (IFNAR2).
Interventions
Patients in nucleos(t)ide analogues treatment for 12 weeks group will receive nucleos(t)ide analogs therapy (Entecavir tablet 0.5mg/d or Tenofovir tablet 300mg/d) from Week 25th to 36th.
DRUGPeginterferon Alfa-2B
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Chronic hepatitis b Patients who should receive anti-HBV therapy according to guideline and are willing to receive interferon therapy; 2. Hepatitis B e antigen positive.
Exclusion criteria
1. Patients received anti-HBV therapy in the past 6 months; 2. Patients with liver cirrhosis or hepatocellular carcinoma or other malignancies; 3. Patients with other factors causing active liver diseases; 4. Pregnancy or lactation women; 5. Patients with HIV infection or congenital immune deficiency diseases; 6. Patients with severe diabetes, autoimmune diseases, other important organ dysfunctions and other serious complications. 7. Patients with other reasons not suitable to receive interferon therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| good virologic response | 24th week | level of HBsAg is less than or equal to 1500 IU/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| common virologic response | 24th week | level of HBsAg is more than 1500 IU/ml, also less than or equal to 20000 IU/ml |
| bad virologic response | 24th week | level of HBsAg is more than 20000 IU/ml, level of HBV DNA is equal to or more than 4.0 log10 IU/ml |
Countries
China
Contacts
Primary ContactWenxiong Xu, Master
Backup ContactLiang Peng, Doctor
Outcome results
None listed