Hepatitis B, Liver Fibrosis
Conditions
Keywords
hepatitis b virus, peginterferon alfa, liver fibrosis
Brief summary
Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to investigate treatment of peginterferon alfa 2a/2b in anti-virus treatment experienced patients with HBV related liver fibrosis.
Detailed description
Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. But there still lacks of studies on peginterferon alfa 2a or 2b treatment in patients with HBV related liver fibrosis. We design this study to investigate optimized treatment of peginterferon alfa 2a/2b, comparing to nucleoside/nucleotide analogues, in anti-virus treatment experienced patients with HBV related liver fibrosis.
Interventions
DRUGTenofovir Disoproxil Fumarate
Patients would receive oral Tenofovir Disoproxil Fumarate 300mg once per day.
DRUGPeginterferon Alfa-2a
Patients would receive subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.
DRUGPeginterferon Alfa-2b
Patients would receive subcutaneous injection of Peginterferon Alfa-2b 80 μg once per week.
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
15 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year; 2. Age from 18 to 55 years old; 3. Fibrosis lever of F1 to F3 from liver biopsy; if liver biopsy unreachable, fibrosis lever of 7 to 14 kpa from fibroscan; 4. Portal vein diameter ≤ 12 mm from liver ultrasound; 5. Receiving treatment of nucleoside/nucleotide analogues at the past one year; 6. Normal liver function; 7. Undetectable hepatitis b virus DNA.
Exclusion criteria
1. Decompensated cirrhosis, hepatocellular carcinoma or other malignancy; 2. Pregnancy or lactation; 3. Other active liver diseases； 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; 8. Investigator considering inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of level of liver fibrosis after anti-virus treatment | 48 week, 144 week | Liver biopsy or fibroscan would be accessed to know the change of level of liver fibrosis at 48 and 144 weeks after anti-virus treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of patients with hepatitis b surface antigen seroconversion after anti-virus treatment | 24 week, 48 week, 72 week, 96 week, 120 week,144 week | Hepatitis b surface antigen and hepatitis b surface antibody would be tested to know the ratio of patients with negative hepatitis B surface antigen and positive hepatitis B surface antibody at 6 time points after anti-virus treatment. |
| Ratio of patients with undetectable hepatitis b virus DNA after anti-virus treatment | 24 week, 48 week, 72 week, 96 week, 120 week,144 week | Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 6 time points after anti-virus treatment. |
| Ratio of patients with hepatitis b e antigen seroconversion after anti-virus treatment | 24 week, 48 week, 72 week, 96 week, 120 week,144 week | Hepatitis b e antigen and hepatitis b e antibody would be tested to know the ratio of patients with negative hepatitis B e antigen and positive hepatitis B e antibody at 6 time points after anti-virus treatment. |
Countries
China
Contacts
Primary ContactWenxiong Xu, Doctor
Backup ContactLiang Peng, Doctor
Outcome results
None listed