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

Sun Yat-sen University

Status and phase: Unknown; Phase 4

Conditions: Chronic Hepatitis b

Treatments: Drug: Peginterferon Alfa-2B; Drug: Entecavir or Tenofovir

Study type: Interventional

Funder types: Other

Identifiers

NCT02973646

PL2

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Nucleos(t)ide analogues treatment

Experimental group

Description:

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.

Treatment:

Drug: Entecavir or Tenofovir

Drug: Peginterferon Alfa-2B

Peginterferon treatment

Active Comparator group

Description:

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.

Treatment:

Drug: Peginterferon Alfa-2B