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

Last updated: November 1, 2016
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Hepatitis

Hepatitis B

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT01237496
ML18675
  • Ages 18-55
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 18months prior to enrollment

  • Participation in study ML18253.

Exclusion

Exclusion Criteria:

  • Interferon-based or any systemic anti-HBV therapy </= 12 months prior to first dose ofstudy drug

  • Antiviral, anti-neoplastic, or immunomodulatory treatment </= 12 months prior to firstdose 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 otherthan HBV

Study Design

Total Participants: 17
Study Start date:
July 01, 2005
Estimated Completion Date:
September 30, 2009

Connect with a study center

  • Bologna, 40138
    Italy

    Site Not Available

  • Brescia, 25125
    Italy

    Site Not Available

  • Milano, 20122
    Italy

    Site Not Available

  • Parma, 43100
    Italy

    Site Not Available

  • Reggio Emilia, 42100
    Italy

    Site Not Available

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