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 naive patients with HBV related liver fibrosis.
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 naive patients with HBV related liver fibrosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Patients would receive oral Tenofovir Disoproxil Fumarate 300mg once per day.
Patients would receive subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.
Patients would receive subcutaneous injection of Peginterferon Alfa-2b 80 μg once per week.
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGChange of level of liver fibrosis after anti-virus treatment
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.
Time frame: 48 week, 144 week
Ratio of patients with undetectable hepatitis b virus DNA after anti-virus treatment
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.
Time frame: 24 week, 48 week, 72 week, 96 week, 120 week,144 week
Ratio of patients with hepatitis B e antigen seroconversion after anti-virus treatment
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.
Time frame: 24 week, 48 week, 72 week, 96 week, 120 week,144 week
Ratio of patients with hepatitis b surface antigen seroconversion after anti-virus treatment
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.
Time frame: 24 week, 48 week, 72 week, 96 week, 120 week,144 week
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