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

Phase 3

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: peginterferon alfa-2a [Pegasys]

• Registration Number: NCT01237496
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	peginterferon alfa-2a [Pegasys]	-

Primary Outcome Measures

Name	Time	Method
CD4 and CD8 mediated immune response: Interferon-y (ELISPOT analysis, flow cytometry)	24 weeks
CD4 and CD8 mediated immune response: Cytokine profile analysis by supernatant culture	24 weeks
CD8 response in HLA-A2 positive patients	24 weeks
CD4 and CD8 mediated immune response: Interleukin-2 production (Flow cytometry)	24 weeks
CD4 and CD8 mediated immune response: Proliferative response upon T-cell stimulation	24 weeks

Secondary Outcome Measures

Name	Time	Method
HBV viremia (HBV RNA assessed by COBAS PaqMan HCV test)	24 weeks
Profile of proinflammatory cytokines: analysis of cytokines in serum	24 weeks