This study will evaluate the efficacy and safety of peginterferon alfa-2a or ADV, in participants with lamivudine-resistant HBeAg-positive chronic hepatitis B. Participants will be randomized to receive either peginterferon alfa-2a for 48 weeks in combination with oral lamivudine for the first 12 weeks, or ADV for 72 weeks in combination with oral lamivudine for the first 12 weeks. The anticipated time on study treatment is 72 weeks, and the target sample size is 255 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
255
ADV will be administered orally at a dose of 10 mg QD for 72 weeks.
Lamivudine tablets will be administered orally at a dose of 10 mg QD for 12 weeks.
Peginterferon alfa-2a injection will be administered at a dose of 180 mcg QW for 48 weeks.
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Chongqing, China
Unnamed facility
Guangzhou, China
Unnamed facility
Hangzhou, China
Unnamed facility
Jinan, China
Unnamed facility
Shanghai, China
Unnamed facility
Shanghai, China
Unnamed facility
Shanghai, China
...and 2 more locations
HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) at Week 72
Time frame: Week 72
Loss of HBeAg
Time frame: Week 48, and 72
Reduction in hepatitis B virus deoxyribonucleic acid (HBV DNA)
Time frame: Week 48, and 72
Alanine transaminase (ALT) normalization
Time frame: Week 48, and 72
Hepatitis B surface antigen (HBsAg) seroconversion
Time frame: Week 48, and 72
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.