Longitudinal Analysis of HBV-specific T Cell Responses in Patients With HBeAg-negative Chronic Hepatitis B (CHB) Treated With Pegylated Interferon Alfa-2a (40 KD) (Pegasys - RO258310). Immunology Sub-study of ML18253
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 17
- Primary Endpoint
- CD4 and CD8 mediated immune response: Interferon-y (ELISPOT analysis, flow cytometry)
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients 18-55 years of age
- •Chronic HBeAg negative hepatitis B
- •Liver disease consistent with chronic hepatitis documented by liver biopsy within 18 months prior to enrollment
- •Participation in study ML18253.
Exclusion Criteria
- •Interferon-based or any systemic anti-HBV therapy </= 12 months prior to first dose of study drug
- •Antiviral, anti-neoplastic, or immunomodulatory treatment </= 12 months prior to first dose of study drug
- •Nonresponders to previous interferon therapy and resistant to lamivudine
- •Co-infection with hepatitis A, C or D, or with human immunodeficiency virus (HIV)
- •Hepatocellular cancer
- •Compensated (Child A, score 6) or decompensated liver disease (Child B or C)
- •History or evidence of medical condition associated with chronic liver disease other than HBV
Arms & Interventions
1
Intervention: peginterferon alfa-2a [Pegasys] (Drug)
Outcomes
Primary Outcomes
CD4 and CD8 mediated immune response: Interferon-y (ELISPOT analysis, flow cytometry)
Time Frame: 24 weeks
CD4 and CD8 mediated immune response: Cytokine profile analysis by supernatant culture
Time Frame: 24 weeks
CD8 response in HLA-A2 positive patients
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: Proliferative response upon T-cell stimulation
Time Frame: 24 weeks
Secondary Outcomes
- HBV viremia (HBV RNA assessed by COBAS PaqMan HCV test)(24 weeks)
- Profile of proinflammatory cytokines: analysis of cytokines in serum(24 weeks)