This 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination therapy in treatment-naive patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms s.c./week for 48 weeks, 2)PEGASYS 180 micrograms s.c./week for 48 weeks + entecavir 0.5mg p.o. once daily from week 13 to week 36 or 3) entecavir 0.5mg p.o. once daily for 24 weeks + PEGASYS 180 micrograms s.c./week from week 21 to 68. Treatment will be followed by 24 weeks treatment-free follow up. The anticipated time on study treatment is 3-12 months for groups 1 and 2, and 1-2 years for group 3, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
219
0.5mg po daily for 24 weeks
0.5mg po daily from week 13 to week 36
180 micrograms sc/week for 48 weeks
180 micrograms sc/week from week 21 to week 68
Unnamed facility
Beijing, China
Unnamed facility
Hangzhou, China
Unnamed facility
Shanghai, China
Unnamed facility
Shanghai, China
Unnamed facility
Shanghai, China
Unnamed facility
Xi'an, China
Unnamed facility
Zhengzhou, China
Unnamed facility
Hong Kong, Hong Kong
Log change in quantitative HBeAg from baseline to 24 weeks after end of treatment.
Time frame: Week 72 for Arms 1 and 2. Week 92 for Arm 3.
HBeAg seroconversion, HBV-DNA <1000 copies/mL, loss of HBeAg, HBV DNA reduction, ALT normalization, loss of HBsAg seroconversion, reduction of HBsAg 24 weeks after end of treatment.
Time frame: Week 72 for Arms 1 and 2. Week 92 for Arm 3.
AEs, laboratory parameters.
Time frame: Throughout study
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