This study will evaluate immune responses in patients with HBeAg-negative chronic Hepatitis B treated with Pegasys (peginterferon alfa-2a). Eligible patients will have been randomized in study ML18253 to receive Pegasys 180 mcg subcutaneously for 48 or 96 weeks. Sample collection period for each patients will occur in the first 24 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
180 mcg sc weekly
Unnamed facility
Bologna, Italy
Unnamed facility
Brescia, Italy
Unnamed facility
Milan, Italy
Unnamed facility
Parma, Italy
Unnamed facility
Reggio Emilia, Italy
CD4 and CD8 mediated immune response: Interferon-y (ELISPOT analysis, flow cytometry)
Time frame: 24 weeks
CD4 and CD8 mediated immune response: Interleukin-2 production (Flow cytometry)
Time frame: 24 weeks
CD4 and CD8 mediated immune response: Cytokine profile analysis by supernatant culture
Time frame: 24 weeks
CD4 and CD8 mediated immune response: Proliferative response upon T-cell stimulation
Time frame: 24 weeks
CD8 response in HLA-A2 positive patients
Time frame: 24 weeks
Profile of proinflammatory cytokines: analysis of cytokines in serum
Time frame: 24 weeks
HBV viremia (HBV RNA assessed by COBAS PaqMan HCV test)
Time frame: 24 weeks
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