Cirrhosis of Liver Due to Hepatitis B (Disorder) Clinical Trial
Official title:
Combination Treatment of Nucleoside （Acid）Analogue (NAs) and Pegylated Interferon α-2b for NAs Treated, Hepatitis B Related, Compensatory Cirrhosis Patients With Low Level Hepatitis b Virus Surface Antigen (HBsAg)
The study aims to demonstrate that whether treatment of nucleoside （acid）analogues (NAs) plus
pegylated interferon (Peg IFN) α-2b for those NAs treated, low level of HBsAg, hepatitis B
related compensatory cirrhosis patients will result in higher HBsAg clearance rate and reduce
the risk of liver cancer. The investigators plan to enroll about 84 hepatitis B related
compensatory cirrhosis patients, who have received NAs treatment more than 1 year with the
level of HBsAg <1000IU/ml. These participants will be devided into 2 groups. Group A will
receive the treatment of NAs plus Peg IFNα-2b. Group B will be treated with NAs as before
enrollment. The participants in both groups will be followed up for 96 weeks.
The primary endpoint is to compare the clearance rate of HBsAg between two groups. The
secondary endpoint includes: (1) comparing the incidence of liver cancer during the 96 weeks
follow-up, (2) comparing adverse side effects between the 2 groups. (3) comparing the
virological and biochemical responses between the 2 groups.
Clearance of hepatitis B virus surface antigen (HBsAg) is considered to be the ultimate
therapeutic goal for hepatitis B patients, for it is related with low incidence of fibrosis
and liver cancer. The investigators' previous study show that nucleoside （acid）analogues
(NAs) treated, non-cirrhosis hepatitis B patients switched to /or combined with pegylated
interferon (Peg IFN)α-2b could obtain a higher HBsAg clearance rate. Hence, the
investigators' hypothesis is that treatment of NAs plus Peg IFNα-2b for those NAs treated,
low level of HBsAg, hepatitis B related compensatory cirrhosis patients result in higher
HBsAg clearance rate and reduce the risk of liver cancer.
The investigators plan to enroll about 84 hepatitis B related compensatory cirrhosis
patients, who have received NAs treatment more than 1 year with the level of HBsAg
<1000IU/ml. These participants will be devided into 2 groups according to their wishes. Group
A will receive the treatment of NAs (patients previously treated with telbivudine will be
changed to entecavir) plus Peg IFNα-2b （180ug per week, the dose will be changed to 135ug or
90ug per week during the treatment if patients could not tolerate the side effects of Peg
IFNα-2b）. Peg IFNα-2b treatment will be performed until HBsAg <0.05IU/ml, with a maximum
duration of 48 weeks. Group B will be treated with NAs as before enrollment. The participants
in both groups will be followed up for 96 weeks.
The primary endpoint is to compare the clearance rate of HBsAg between two groups. The
secondary endpoint includes: (1) comparing the incidence of liver cancer during the 96 weeks
follow-up, (2) comparing adverse side effects, such as ascites, gastrointestinal bleeding,
encephalopathy, hepatorenal syndrome between the 2 groups. (3) comparing the virological and
biochemical responses between the 2 groups.
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