The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects. The secondary purposes is to get the PK/PD data in recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects.
This is an open-label study that will be conducted at three sites in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein in HBV subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator Pegasys at Day 0. A multipule-dose administration in HBV subjects will last 12 weeks after four weeks washout period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
In experiemental groups, each subject will recieve 600,750,900mg once per two weeks during multiple dose period.
In comparator group, each subject will recieve 180mcg once per week.
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, China
the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment
HBV DNA
Time frame: 17 weeks
the rates of HBV DNA level decrease by more than 2log10 at the end of 4 weeks and after treatment
HBV DNA
Time frame: 4 weeks and 17 weeks
the recovery rates of ALT after treatment
ALT
Time frame: 17 weeks
the negative conversion rates of HBsAg/HBeAg and HBeAg seroconversion rates after treatment
HBsAg/HBeAg
Time frame: 17 weeks
the rates of HBsAg decrease from baseline after treatment
HBsAg
Time frame: 17 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.