This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive, interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
307
Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.
Unnamed facility
Beijing, China
Unnamed facility
Guangzhou, China
Unnamed facility
Shanghai, China
Percentage of participants with HBV deoxyribonucleic acid (DNA) less than (<) 100,000 copies per milliliters (copies/mL)
Time frame: 72 weeks
Percentage of participants with HBeAg seroconversion
Time frame: 72 weeks
Number of participants who achieved HBV DNA levels below limit of detection
Time frame: Weeks 48 and 72
Number of participants with HBsAg loss
Time frame: Weeks 48 and 72
Number of participants with both Hepatitis B Surface Antigen (HBsAg) loss and presence of Anti-HBs
Time frame: Weeks 48 and 72
Number of participants with alanine aminotransferase (ALT) normalization
Time frame: Weeks 48 and 72
Number of participants with combined response (HBV DNA <100,000 copies/mL, HBeAg loss, and ALT normalization)
Time frame: Weeks 48 and 72
Incidence of adverse events
Time frame: up to 72 weeks
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