Chronic Hepatitis b, Efficacy, Self
Conditions
Keywords
Chronic Hepatitis B, entecavir
Brief summary
There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Tenofovir or interferon alfa is the optimal choice right now. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.
Detailed description
There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Poor efficacy is defined as hepatitis b virus DNA is still positive and decreases \> 2 lg from baseline. Sequential therapy by using tenofovir or interferon alfa is the optimal choice right now. 100 patients with poor antiviral efficacy of entecavir will be recruited in this study. They are randomly divided into tenofovir group or interferon alfa group. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.
Interventions
Patents are treated with interferon alfa 2a 180μg hypodermic injection once per week for 48 weeks. Then, interferon alfa 2a will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be used if HBsAg is positive.
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Hepatitis b virus DNA or HBsAg positive for over half a year; 2. Age from 18 to 65; 3. With poor efficacy of entecavir: Hepatitis b virus DNA is still positive at 24 weeks, and decrease \> 2 lg from baseline . 4. Not be treated with interferon alfa ever before.
Exclusion criteria
1. Other active liver diseases; 2. Cirrhosis, hepatocellular carcinoma or other malignancy; 3. Pregnancy or lactation; 4. Human immunodeficiency virus infection or congenital immune deficiency diseases; 5. Severe diabetes, autoimmune diseases; 6. Other important organ dysfunctions; 7. Patients can not follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HBsAg decrease after 48 weeks treatment | 48 weeks | The patients recruited will be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of HBsAg will be tested again. The investigators want to know the rate of patients with HBsAg level that decreases more than 2 lg from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HBsAg clearance after 48 weeks treatment | 48 weeks | The patients recruited would be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of HBsAg will be tested again. The investigators want to know the rate of patients with HBsAg clearance which is lower than 0.05 IU/ml. |
| Undetectable hepatitis b virus DNA after 48 weeks treatment | 48 weeks | The patients recruited would be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of hepatitis b virus DNA will be tested again. The investigators want to know the rate of patients with undetectable hepatitis b virus DNA which is lower than 20 IU/ml. |
Countries
China
Contacts
Primary ContactWenxiong Xu, Doctor
Backup ContactLiang Peng, Doctor
Outcome results
None listed