Peginterferon Alfa-2b Treatment in HBeAg(+) Chronic Hepatitis b Patients Based on Interferon Gene Mutation and Receptor Detection

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Chronic Hepatitis b

Intervention / Treatment
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* Drug: Entecavir or Tenofovir
* Drug: Peginterferon Alfa-2B


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nucleos(t)ide analogues treatment<br>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. | Drug: Entecavir or Tenofovir<br>* 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.<br>* Other names: Viread;Drug: Peginterferon Alfa-2B<br> <br> |
| Active Comparator: Peginterferon treatment<br>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. | Drug: Peginterferon Alfa-2B<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| good virologic response | level of HBsAg is less than or equal to 1500 IU/ml | 24th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| common virologic response | level of HBsAg is more than 1500 IU/ml, also less than or equal to 20000 IU/ml | 24th week | 
| bad virologic response | level of HBsAg is more than 20000 IU/ml, level of HBV DNA is equal to or more than 4.0 log10 IU/ml | 24th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic hepatitis b, peginterferon alfa-2b, interferon gene mutation, interferon receptor