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

Hepatitis B, Chronic Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237496
• Other study ID #: ML18675
• Status: Completed
• Phase: Phase 3
• First received: November 8, 2010
• Last updated: November 1, 2016
• Start date: July 2005
• Est. completion date: September 2009

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• peginterferon alfa-2a [Pegasys]
180 mcg sc weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD4 and CD8 mediated immune response: Interferon-y (ELISPOT analysis, flow cytometry)		24 weeks	No
Primary	CD4 and CD8 mediated immune response: Interleukin-2 production (Flow cytometry)		24 weeks	No
Primary	CD4 and CD8 mediated immune response: Cytokine profile analysis by supernatant culture		24 weeks	No
Primary	CD4 and CD8 mediated immune response: Proliferative response upon T-cell stimulation		24 weeks	No
Primary	CD8 response in HLA-A2 positive patients		24 weeks	No
Secondary	Profile of proinflammatory cytokines: analysis of cytokines in serum		24 weeks	No
Secondary	HBV viremia (HBV RNA assessed by COBAS PaqMan HCV test)		24 weeks	No