Investigation on Antiviral Therapy of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B Patients Based on Detection of Interferon Gene Mutation and Interferon Receptor
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- good virologic response
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Chronic hepatitis b Patients who should receive anti-HBV therapy according to guideline and are willing to receive interferon therapy;
- •Hepatitis B e antigen positive.
Exclusion Criteria
- •Patients received anti-HBV therapy in the past 6 months;
- •Patients with liver cirrhosis or hepatocellular carcinoma or other malignancies;
- •Patients with other factors causing active liver diseases;
- •Pregnancy or lactation women;
- •Patients with HIV infection or congenital immune deficiency diseases;
- •Patients with severe diabetes, autoimmune diseases, other important organ dysfunctions and other serious complications.
- •Patients with other reasons not suitable to receive interferon therapy.
Arms & Interventions
Nucleos(t)ide analogues treatment
Patients with interferon receptor level down-regulated at the 24th week. Patients of this group will receive peginterferon alfa-2b injection 80ug/d from baseline to 24th week, then nucleos(t)ide analogues (entecavir tablet 0.5mg/d or tenofovir tablet 300mg/d) from 25th to 36th week, then peginterferon alfa-2b injection 80ug/d again from 36th to 48th week.
Intervention: Entecavir or Tenofovir (Drug)
Nucleos(t)ide analogues treatment
Patients with interferon receptor level down-regulated at the 24th week. Patients of this group will receive peginterferon alfa-2b injection 80ug/d from baseline to 24th week, then nucleos(t)ide analogues (entecavir tablet 0.5mg/d or tenofovir tablet 300mg/d) from 25th to 36th week, then peginterferon alfa-2b injection 80ug/d again from 36th to 48th week.
Intervention: Peginterferon Alfa-2B (Drug)
Peginterferon treatment
Patients with interferon receptor level not down-regulated at the 24th week. Patients of this group will receive peginterferon alfa-2b injection 80ug/d from baseline to 48th week.
Intervention: Peginterferon Alfa-2B (Drug)
Outcomes
Primary Outcomes
good virologic response
Time Frame: 24th week
level of HBsAg is less than or equal to 1500 IU/ml
Secondary Outcomes
- common virologic response(24th week)
- bad virologic response(24th week)
Investigators
Liang Peng
Associated Professor
Third Affiliated Hospital, Sun Yat-Sen University