The CHB subjects who are cirrhosis, will be randomized to two groups. The subjects who go into group A will be treated by nucleotide analogue (NA) combination with peginterferon alfa-2a,180μg/week for 48 weeks. The subjects who go into group B will be treated by nucleotide analogue (NA) only for 48 weeks.
This study is a prospective, randomized, open-label study. The CHB subjects who are cirrhosis will be randomized to two groups. The subjects who go into group A will be treated by nucleotide analogue (NA) combination with peginterferon alfa-2a,180μg/week for 48 weeks. The subjects who go into group B will be treated by nucleotide analogue (NA) only for 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
180μg/week, 48 weeks; 135μg/week,48weeks
Adefovir, entecavir,tenofovir, either of them is ok
Nanhua Hospital
Shanghai, China
Number of subjects who develop to hepatocellular carcinoma during 5 years
The number of subjects develop to hepatocellular carcinoma during 5 years will be measured
Time frame: 5 years
Number of participants who achieve HBeAg loss and HBeAg seroconversion
The number of subjects with HBeAg loss and HBeAg seroconversion at year 1 ,2,3,4 and 5 will be measured
Time frame: year 1,2,3,4,5
Number of participants who achieve HBsAg loss and HBsAg seroconversion
The number of subjects with HBsAg loss and HBsAg seroconversion at year 1, 2,3,4 and 5 will be measured
Time frame: year 1,2,3,4,5
The factor such as HBsAg level related to the incidence of HCC development
The HBsAg level at year 1 will be measured, to assess whether the quantitative HBsAg level related to the incidence of HCC development
Time frame: year 1
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