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CompletedNCT01237496Updated Nov 2, 2016

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

A Phase 3 interventional study of peginterferon alfa-2a [Pegasys] in Hepatitis B, Chronic, sponsored by Hoffmann-La Roche. Completed at 5 sites in Italy. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
17
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

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.

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Conditions studied

  • Hepatitis B, Chronic
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In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 17 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    1

    Drug: peginterferon alfa-2a [Pegasys]

Interventions

  • Drugpeginterferon alfa-2a [Pegasys]

    180 mcg sc weekly

06

What researchers measure

Primary outcomes

  1. CD4 and CD8 mediated immune response: Interferon-y (ELISPOT analysis, flow cytometry)

    Time frame: 24 weeks

  2. CD4 and CD8 mediated immune response: Interleukin-2 production (Flow cytometry)

    Time frame: 24 weeks

  3. CD4 and CD8 mediated immune response: Cytokine profile analysis by supernatant culture

    Time frame: 24 weeks

  4. CD4 and CD8 mediated immune response: Proliferative response upon T-cell stimulation

    Time frame: 24 weeks

  5. CD8 response in HLA-A2 positive patients

    Time frame: 24 weeks

Secondary outcomes

  1. Profile of proinflammatory cytokines: analysis of cytokines in serum

    Time frame: 24 weeks

  2. HBV viremia (HBV RNA assessed by COBAS PaqMan HCV test)

    Time frame: 24 weeks

07

Study locations

5 sites
  • Bologna, 40138, Italy
  • Brescia, 25125, Italy
  • Milano, 20122, Italy
  • Parma, 43100, Italy
  • Reggio Emilia, 42100, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01237496
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Nov 9, 2010
Start date
Jul 2005
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study chair · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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