The current study is a prospective, randomized, open, multi-center investigation. The aim of the study is to investigate whether the HBeAg seroconversion rate can be improved if applying combination therapy in HBeAg positive CHB patients who has achieved HBVDNA\<105copies/ml,HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2.
The HBeAg positive chronic hepatitis B(CHB) subjects who has achieved HBV DNA\<10\*5copies/ml,HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2 will be randomized to three groups. The subjects who go into group A will be treated by tenofovir disoproxil fumarate (TDF) for 96 weeks; The subjects who go into group B will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks; The subjects who go into group C will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
TDF for 96 weeks
Subjects will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks
Subjects will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks.
Xixi Hospital of Hangzhou
Hangzhou, China
RECRUITINGChanghai Hospital
Shanghai, China
RECRUITINGHua shan Hospital,Fudan University
Shanghai, China
Number of subjects who achieve HBeAg seroconversion
The number of subjects with HBeAg seroconversion at week 96 will be measured
Time frame: at 96 week
Number of participants who achieve HBeAg seroconversion
The number of subjects with HBeAg seroconversion at week 48 and 72 will be measured
Time frame: at 48 week;at 72 week
The percentage decrease of HBsAg level at group A,B,C
The level of HBsAg in group A,B,C at week 48 ,72 and 96 will be measured,changing from baseline
Time frame: at 48 week;at 72 week;at 96 week
Number of participants who achieve HBeAg loss
The number of subjects with HBeAg loss at week48.72 and 96 will be measured
Time frame: at 48 week;at 72 week;at 96 week
The number of subjects who achieve HBVDNA undetectable
The number of subjects with HBVDNA undetectable at week 24,48,72 and 96 will be measured
Time frame: at 24 week;48 week;at 72 week;at 96 week
The factor such as HBsAg level related to responsible rate
The HBsAg level at week 48,72,96 will be measured, to assess whether the quantitative HBsAg level related to the responsible rate
Time frame: at week 48,72,96
The number of subjects who achieve ALT back to normal
The number of subjects with normal ALT at week 48,72 and 96 will be measured
Time frame: at 48 week;at 72 week;at 96 week
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Infectious diesease hospital of Huangpu district in Shanghai
Shanghai, China
RECRUITINGNo.9 hospital of shanghai
Shanghai, China
RECRUITINGShanghai public health clinical center
Shanghai, China
RECRUITINGShuguang Hospital of Shanghai T.C.M
Shanghai, China
RECRUITINGTongren hospital Shanghai Jiaotong University School of medicine
Shanghai, China
RECRUITING