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
NCT ID: NCT01237496
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
17 participants
INTERVENTIONAL
2005-07-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
peginterferon alfa-2a [Pegasys]
180 mcg sc weekly
Interventions
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peginterferon alfa-2a [Pegasys]
180 mcg sc weekly
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Bologna, , Italy
Brescia, , Italy
Milan, , Italy
Parma, , Italy
Reggio Emilia, , Italy
Countries
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Other Identifiers
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ML18675
Identifier Type: -
Identifier Source: org_study_id