Analysis of HBV-Specific Immune Response in Patients With HBeAg Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a (40KD)) - Immunology Sub-Study of ML18253

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01237496

Enrollment

Registered

2010-11-09

Start date

2005-07-31

Completion date

2009-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

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.

Interventions

DRUGpeginterferon alfa-2a [Pegasys]

180 mcg sc weekly

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
CD4 and CD8 mediated immune response: Interleukin-2 production (Flow cytometry)	24 weeks
CD4 and CD8 mediated immune response: Proliferative response upon T-cell stimulation	24 weeks
CD8 response in HLA-A2 positive patients	24 weeks
CD4 and CD8 mediated immune response: Interferon-y (ELISPOT analysis, flow cytometry)	24 weeks
CD4 and CD8 mediated immune response: Cytokine profile analysis by supernatant culture	24 weeks

Secondary

Measure	Time frame
HBV viremia (HBV RNA assessed by COBAS PaqMan HCV test)	24 weeks
Profile of proinflammatory cytokines: analysis of cytokines in serum	24 weeks

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026