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NCT Number: NCT01237496

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 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.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bologna, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

peginterferon alfa-2a [Pegasys]

Drug

180 mcg sc weekly

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Nov 9, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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