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

Phase 4

• Conditions: Chronic Hepatitis b
• Interventions: Drug: Entecavir or Tenofovir; Drug: Peginterferon Alfa-2B

• Registration Number: NCT02973646
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

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 Timeline

• Study Start: 2016-01
• Status Verified: 2016-11
• Study First Submitted: 2016-11-13
• Study First Submitted QC: 2016-11-23
• Last Update Submitted: 2016-11-23
• Study First Posted: 2016-11-25
• Last Update Posted: 2016-11-25
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nucleos(t)ide analogues treatment	Entecavir or Tenofovir	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.
Nucleos(t)ide analogues treatment	Peginterferon Alfa-2B	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.
Peginterferon treatment	Peginterferon Alfa-2B	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.

Primary Outcome Measures

Name	Time	Method
good virologic response	24th week	level of HBsAg is less than or equal to 1500 IU/ml

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China