This is a prospective, randomized, multicenter, open-label study. After more than 24 weeks NA treatment, HBeAg positive CHB patients who achieved HBV DNA\<1000copies/ml but HBeAb negative, will be randomized (1:1) into 2 study arms as follows: Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1 piece qd for 48 weeks Arm B: Entecavir 0.5mg qd for 48 weeks
This is a prospective, randomized, multicenter, open-label study. After more than 24 weeks NA treatment, HBeAg positive CHB patients who achieved HBV DNA\<1000copies/ml but HBeAb negative, will be randomized (1:1) into 2 study arms as follows: Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1piece qd for 48 weeks Arm B:NA 1 piece qd for 48 weeks The primary endpoint: HBeAg seroconversion at week 48
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
366
Peginterferon alfa-2a 180ug/wk s.c for 48 weeks
nucleos(t)ide analgoue (NA) 1 piece p.o for 48 weeks
The Third People's Hospital of Guilin
Guilin, China
RECRUITINGRuijin Hospital
Shanghai, China
RECRUITINGShanghai Public Health Clinical Center
Shanghai, China
RECRUITINGNumber of participants who achieve HBeAg seroconversion
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the HBeAg seroconversion in HBeAg positive CHB patients on treatment with Entecavir and with HBV DNA \<1000copies/ml which will be measured by the number of participants who achieve HBeAg seroconversion
Time frame: at week 48
Number of participants who achieve HBeAg loss
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve HBeAg seroconversion which will be measured by number of participants who achieve HBeAg loss
Time frame: at week 48
Number of participants who achieve HBsAg loss
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve HBsAg loss which will be measured by number of participants who achieve HBsAg loss
Time frame: at week 48
Number of participants who achieve HBsAg seroconversion
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve HBsAg seroconversion which will be measured by number of participants who achieve HBsAg seroconversion
Time frame: at week 48
HBsAg decline from baseline
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve HBsAg decline from baseline
Time frame: at week 48
Percentage of participants who achieve HBsAg <1000IU/mL
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the percentage of participants who achieve HBsAg\<1000IU/mL
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Time frame: at week 48
Percentage of of participants who achieve HBsAg <100IU/mL
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the percentage of of participants who achieve HBsAg\<100IU/mL
Time frame: at week 48
Number of participants who achieve combined response I (defined as HBeAg seroconversion and HBV DNA<100000copies/mL)
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the combined response I which will be measured by number of participants who achieve combined response I
Time frame: at week 48
Number of participants who achieve combined response II (defined as HBeAg seroconversion and HBV DNA<1000copies/mL)
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the combined response II which will be measured by number of participants who achieve combined response II
Time frame: at week 48
Number of participants who achieve dural response I (defined as HBeAg seroconversion and HBsAg<1000IU/mL)
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the dural response I which will be measured by number of participants who achieve dural response I
Time frame: at week 48
Number of participants who achieve dural response II (defined as HBeAg seroconversion and HBsAg<100IU/mL)
To investigate whether the combined therapy with Peginterferon alfa-2a with Entecavir can improve the dural response II which will be measured by number of participants who achieve dural response II
Time frame: at week 48
Number of Participants with AE
Number of participants with adverse events as a measure of safety and tolerability
Time frame: at week 48
Number of Participants with SAE
Number of participants with SAEs as a measure of safety and tolerability
Time frame: at week 48