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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: November 8, 2010
Last updated: April 7, 2014
Last verified: April 2014

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.

Condition Intervention Phase
Hepatitis B, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • CD4 and CD8 mediated immune response: Interferon-y (ELISPOT analysis, flow cytometry) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • CD4 and CD8 mediated immune response: Interleukin-2 production (Flow cytometry) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • CD4 and CD8 mediated immune response: Cytokine profile analysis by supernatant culture [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • CD4 and CD8 mediated immune response: Proliferative response upon T-cell stimulation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • CD8 response in HLA-A2 positive patients [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Profile of proinflammatory cytokines: analysis of cytokines in serum [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • HBV viremia (HBV RNA assessed by COBAS PaqMan HCV test) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: July 2005
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT01237496

Bologna, Italy, 40138
Brescia, Italy, 25125
Milano, Italy, 20122
Parma, Italy, 43100
Reggio Emilia, Italy, 42100
Sponsors and Collaborators
Hoffmann-La Roche
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01237496     History of Changes
Other Study ID Numbers: ML18675
Study First Received: November 8, 2010
Last Updated: April 7, 2014
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs processed this record on April 16, 2014