This is a prospective study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
the Fifth Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe rate of HBsAg loss (<0.05 IU/ml) at 24 weeks and 48 weeks
Evaluate the level of HBsAg (IU/ml) 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 (IU/ml) at 24 weeks and 48 weeks.
Time frame: 48 weeks
The rate of HBsAb positive (>10 IU/ml) at 24 weeks and 48 weeks.
The rate of HBsAb positive (\>10 IU/ml) at 24 weeks and 48 weeks.
Time frame: 48 weeks
The concentration of HBcrAg (logU/mL) at baseline, 12 weeks, 24 weeks and 48 weeks
Evaluate the level of serum HBcrAg (logU/mL) at baseline, 12 weeks, 24 weeks and 48 weeks.
Time frame: 48 weeks
The concentration of pgRNA (>10 IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks
Evaluate the level of serum pgRNA (\>10 IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks
Time frame: 48 weeks
The concentration of anti-HBc (IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks
Evaluate the level of serum anti-HBc (IU/ml) 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