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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01237496
Recruitment Status : Completed
First Posted : November 9, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2005
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly

Primary Outcome Measures :
  1. CD4 and CD8 mediated immune response: Interferon-y (ELISPOT analysis, flow cytometry) [ Time Frame: 24 weeks ]
  2. CD4 and CD8 mediated immune response: Interleukin-2 production (Flow cytometry) [ Time Frame: 24 weeks ]
  3. CD4 and CD8 mediated immune response: Cytokine profile analysis by supernatant culture [ Time Frame: 24 weeks ]
  4. CD4 and CD8 mediated immune response: Proliferative response upon T-cell stimulation [ Time Frame: 24 weeks ]
  5. CD8 response in HLA-A2 positive patients [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Profile of proinflammatory cytokines: analysis of cytokines in serum [ Time Frame: 24 weeks ]
  2. HBV viremia (HBV RNA assessed by COBAS PaqMan HCV test) [ Time Frame: 24 weeks ]

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Hoffmann-La Roche Identifier: NCT01237496     History of Changes
Other Study ID Numbers: ML18675
First Posted: November 9, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
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
Immunologic Factors
Physiological Effects of Drugs