Status:
COMPLETED
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01237496
Start Date
July 1 2005
End Date
September 1 2009
Last Update
November 2 2016
Active Locations (5)
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1
Bologna, Italy, 40138
2
Brescia, Italy, 25125
3
Milan, Italy, 20122
4
Parma, Italy, 43100