A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)
NCT ID: NCT02604823
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
PHASE4
307 participants
INTERVENTIONAL
2003-11-30
2005-11-30
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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Group A (Naïve Participants)
Participants who never received any HBV treatment, will receive peginterferon alfa-2a (180 micrograms \[mcg\]) subcutaneously once weekly for 48 weeks.
Peginterferon alfa-2a
Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.
Group B (Conventional Interferon Pretreated Participants)
Participants who received conventional interferon treatment and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.
Peginterferon alfa-2a
Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.
Group C (Lamivudine Pretreated Participants)
Participants who received lamivudine and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.
Peginterferon alfa-2a
Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.
Interventions
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Peginterferon alfa-2a
Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HBeAg-positive chronic HBV
* Treatment-naive, or have received and have not responded to or have relapsed on either conventional interferon or lamivudine therapy.
Exclusion Criteria
* Co-infection with active hepatitis A, C or D virus or with human immunodeficiency virus (HIV)
* Evidence of decompensated liver disease
* 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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Beijing, , China
Guangzhou, , China
Shanghai, , China
Countries
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Other Identifiers
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ML17700
Identifier Type: -
Identifier Source: org_study_id