This study evaluates whether addition of Peginterferon alfa-2a to CHB Patients Treated with nucleoside analogues (NAs) can enhance the rate of HBsAg clearance at end of treatment. This study is a Randomized, open-label, multi-center study. The CHB patients with NAs treatment and have achieved HBV DNA \<15 IU/ml、HBeAg \<100 PEIU/ml、HBsAg positive and HBsAg\<1500 IU/ml will be randomized into 2 groups: Group 1 (Combination group): Maintain NAs treatment while add 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 (Mono NA group) : Maintain NAs treatment for 49 weeks. Note: NAs including: LAM, ADV, ETV, or TDF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
180ug/0.5ml,hypodermic injection once a week
Kaifeng Central Hospitl
Kaifeng, Henan, China
Weishi County People's Hospital
Kaifeng, Henan, China
Luoyang Central Hospital
Luoyang, Henan, China
Shangqiu No.1 People's Hospital
Shangqiu, Henan, China
Henan People's Hospital
Zhengzhou, Henan, China
The rate of HBsAg loss
To determine the response rate will be evaluated by HBsAg loss defined as HBsAg level lower than 0.05 IU/ml after 48 week treatment, compared with control group.
Time frame: 48 weeks
Decline of HBeAg quantification
Quantitative HBeAg reduction at Weeks 12, 24 and 48 compared with baseline level. Quantitative HBeAg value unit was calculated using 'Paul Ehrlich Institute units per millilitre' (PEIU/ml).
Time frame: 12 weeks, 24 weeks, 48 weeks of treatment
Decline of HBsAg quantification
Quantitative HBsAg reduction at Weeks 12, 24 and 48 compared with baseline level. Quantitative HBsAg calculated using 'International Units Per Millilitre' (IU/mL).
Time frame: 12 weeks, 24 weeks, 48 weeks of treatment
The rate of HBeAg loss
Time frame: 48 weeks
The rate of HBeAg seroconversion
Time frame: 48 weeks
The rate of HBsAg seroconversion
Time frame: 48 weeks
Sustained virological response rate
Sustained virological response rate will be presented as rate of HBV DNA \<15 IU/ml
Time frame: 12 weeks, 24 weeks, 48 weeks of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.