Effects of a late add-on therapy of pegylated interferon (peg-IFNA) to ongoing nucleos(t)ide

INTERVENTION: Trade Name: Pegasys Product Name: pegylated interferon alpha 2a Pharmaceutical Form: Suspension for injection in pre‐filled pen CONDITION: Chronic hepatitis B Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: Main Objective: To determine whether add‐on of peg‐IFN‐a to an ongoing effective nucleos(t)ide therapy achieve higher rates of seroconversion in CHB patients. Primary end point(s): Loss of HBsAg and/or HBeAg Secondary Objective: To investigate the the immunomodulatory action of IFNa, particularly on the host innate response through the analysis of the mechanisms involved in the restoration of NK cell effector functions in the “add‐on” strategy described above. Timepoint(s) of evaluation of this end point: Baseline‐week12‐week24‐week48 SECONDARY OUTCOME: Secondary end point(s): Sustained virological response or therapy suspension at the end of 48 weeks of treatment. Timepoint(s) of evaluation of this end point: 12‐24‐48‐weeks INCLUSION CRITERIA: age 18‐65 years HBsAg positivity treatment with NUCs for at least 2 years; compensated liver disease; Hb > 12 g/dl WBC > 3000/mm3 PLT >100000 ANA, AMA, ASMA, LKM‐Ab negativity HCV‐Ab and HIV‐Ab negative; Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range