Chronic hepatitis B
Conditions
Interventions
Trade Name: Pegasys
Product Name: pegylated interferon alpha 2a
Pharmaceutical Form: Suspension for injection in pre-filled pen
Sponsors
Azienda Ospedaliera, Polo Universitario Luigi Sacco, Milano
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: HCV or HIV coinfection; Pregnancy: Other liver diseases besides chronic hepatitis B fuori dell’epatite B; decompensated liver disease; Autoimmunity; Major depression hypersensitivity to Pegylated interferon Uncontrolled pilepsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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.;Primary end point(s): Loss of HBsAg and/or HBeAg;Timepoint(s) of evaluation of this end point: Baseline-week12-week24-week48 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactIII Division of Infectious Diseases
Azienda Ospedaliera, Polo Universitario Luigi Sacco, Milano
Outcome results
None listed