add-on therapy of HBV chronic infectio
- Conditions
- Chronic hepatitis BTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-000815-15-IT
- Lead Sponsor
- Azienda Ospedaliera, Polo Universitario Luigi Sacco, Milano
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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