Back to resultsAnalysis 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
Primary Purpose
Hepatitis B, Chronic
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
peginterferon alfa-2a [Pegasys]
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
CD4 and CD8 mediated immune response: Interferon-y (ELISPOT analysis, flow cytometry)
CD4 and CD8 mediated immune response: Interleukin-2 production (Flow cytometry)
CD4 and CD8 mediated immune response: Cytokine profile analysis by supernatant culture
CD4 and CD8 mediated immune response: Proliferative response upon T-cell stimulation
CD8 response in HLA-A2 positive patients
Secondary Outcome Measures
Profile of proinflammatory cytokines: analysis of cytokines in serum
HBV viremia (HBV RNA assessed by COBAS PaqMan HCV test)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01237496
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 mcg sc weekly
Primary Outcome Measure Information:
Title
CD4 and CD8 mediated immune response: Interferon-y (ELISPOT analysis, flow cytometry)
Time Frame
24 weeks
Title
CD4 and CD8 mediated immune response: Interleukin-2 production (Flow cytometry)
Time Frame
24 weeks
Title
CD4 and CD8 mediated immune response: Cytokine profile analysis by supernatant culture
Time Frame
24 weeks
Title
CD4 and CD8 mediated immune response: Proliferative response upon T-cell stimulation
Time Frame
24 weeks
Title
CD8 response in HLA-A2 positive patients
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Profile of proinflammatory cytokines: analysis of cytokines in serum
Time Frame
24 weeks
Title
HBV viremia (HBV RNA assessed by COBAS PaqMan HCV test)
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Bologna
ZIP/Postal Code
40138
Country
Italy
City
Brescia
ZIP/Postal Code
25125
Country
Italy
City
Milano
ZIP/Postal Code
20122
Country
Italy
City
Parma
ZIP/Postal Code
43100
Country
Italy
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
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
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