This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a \[PEGASYS\] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is \>2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
265
Adefovir 10 mg po once daily for 36 weeks
Early responders: PEGASYS 180 mcg sc once weekly for 48 weeks
Non-early responders: PEGASYS 180 mcg sc once weekly for 48 weeks
Non-early responders: PEGASYS 180 mcg sc once weekly for 96 weeks
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Changchun, China
Unnamed facility
Guangzhou, China
Unnamed facility
Shanghai, China
Unnamed facility
Shanghai, China
Unnamed facility
Shanghai, China
Unnamed facility
Wuhan, China
...and 1 more locations
Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction)
Time frame: Weeks 72, 96, 120
Proportion of patients achieving HBeAG seroconversion and HBV DNA </=100000 copies/ml
Time frame: Weeks 24, 48, 72, 96, 120
Safety: Adverse Events
Time frame: From baseline to Week 120
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