This is a prospective, open-labled, randomized controlled study to assess efficacy and safety of treatment with Sintilimab (PD-1 antibody) combined Peg-IFNα-2b in CHB patients on stable NAs treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
the Fifth Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe rate of HBsAg loss at 24 weeks and 48 weeks.
Evaluate the level of HBsAg at 24 weeks and 48 weeks.
Time frame: 48 weeks
Incidence of treatment-emergent adverse events/serious adverse events
Evaluate the treatment-emergent adverse events/serious adverse events
Time frame: 48 weeks
The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks
Evaluate the level of serum HBsAg at 24 weeks and 48 weeks.
Time frame: 48 weeks
The rate of HBsAb positive at 24 weeks and 48 weeks.
Evaluate the level of serum HBsAb at 24 weeks and 48 weeks.
Time frame: 48 weeks
The concentration of HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks.
Evaluate the level of serum HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks.
Time frame: 48 weeks
The concentration of pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks.
Evaluate the level of serum pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks.
Time frame: 48 weeks
The concentration of anti-HBc at baseline, 12 weeks, 24 weeks and 48 weeks.
Evaluate the level of serum anti-HBc at baseline, 12 weeks, 24 weeks and 48 weeks.
Time frame: 48 weeks
Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks.
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Evaluate the frequency and function of T cell, B cell, NK cell (tested by flowcytometry/fluorospot/elispot)
Time frame: 48 weeks