Peginterferon Alfa-2b Treatment in HBeAg(+) Chronic Hepatitis b Patients Based on Interferon Gene Mutation and Receptor Detection
Keywords
Abstract
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).
Dates
| Last Verified: | 10/31/2016 |
| First Submitted: | 11/12/2016 |
| Estimated Enrollment Submitted: | 11/22/2016 |
| First Posted: | 11/24/2016 |
| Last Update Submitted: | 11/22/2016 |
| Last Update Posted: | 11/24/2016 |
| Actual Study Start Date: | 12/31/2015 |
| Estimated Primary Completion Date: | 11/30/2018 |
| Estimated Study Completion Date: | 11/30/2018 |
Condition or disease
Intervention/treatment
Drug: Nucleos(t)ide analogues treatment
Drug: Peginterferon Alfa-2B
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: 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. | Drug: Nucleos(t)ide analogues treatment 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. |
| Active Comparator: 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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. |
Outcome
Primary Outcome Measures
1. good virologic response [24th week]
Secondary Outcome Measures
1. common virologic response [24th week]
2. bad virologic response [24th week]
