- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01237496
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
November 1, 2016 updated by: Hoffmann-La Roche
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bologna, Italy, 40138
-
Brescia, Italy, 25125
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Milano, Italy, 20122
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Parma, Italy, 43100
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Reggio Emilia, Italy, 42100
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
180 mcg sc weekly
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CD4 and CD8 mediated immune response: Interferon-y (ELISPOT analysis, flow cytometry)
Time Frame: 24 weeks
|
24 weeks
|
CD4 and CD8 mediated immune response: Interleukin-2 production (Flow cytometry)
Time Frame: 24 weeks
|
24 weeks
|
CD4 and CD8 mediated immune response: Cytokine profile analysis by supernatant culture
Time Frame: 24 weeks
|
24 weeks
|
CD4 and CD8 mediated immune response: Proliferative response upon T-cell stimulation
Time Frame: 24 weeks
|
24 weeks
|
CD8 response in HLA-A2 positive patients
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Profile of proinflammatory cytokines: analysis of cytokines in serum
Time Frame: 24 weeks
|
24 weeks
|
HBV viremia (HBV RNA assessed by COBAS PaqMan HCV test)
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
November 8, 2010
First Submitted That Met QC Criteria
November 8, 2010
First Posted (Estimate)
November 9, 2010
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Peginterferon alfa-2a
Other Study ID Numbers
- ML18675
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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