A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.
NCT ID: NCT01519921
Last Updated: 2016-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
150 participants
INTERVENTIONAL
2005-10-31
2008-06-30
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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PEG-IFN alfa-2a (Treatment naïve)
Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
peginterferon alfa-2a [Pegasys]
Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks
PEG-IFN alfa-2a (YMDD mutant)
Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
peginterferon alfa-2a [Pegasys]
Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks
Interventions
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peginterferon alfa-2a [Pegasys]
Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks
Eligibility Criteria
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Inclusion Criteria
* HBsAg +ve for more than 6 months, HBeAg +ve, AntiHBs -ve
* Detectable hepatitis B virus (HBV) DNA (\>100,000 copies/mL)
Exclusion Criteria
* Evidence of decompensated liver disease
* A medical condition associated with chronic liver disease other than viral hepatitis
18 Years
65 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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Busan, , South Korea
Daegu, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Countries
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Other Identifiers
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ML18495
Identifier Type: -
Identifier Source: org_study_id
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