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

Roche

Status and phase: Completed; Phase 3

Conditions: Hepatitis B, Chronic

Treatments: Drug: peginterferon alfa-2a [Pegasys]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01237496

ML18675

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

1

Experimental group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]