A Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (Pegasys) and Adeforvir Dipivoxil (ADV) in Participants With Lamivudine-Resistant Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B
NCT ID: NCT02598063
Last Updated: 2016-02-02
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
255 participants
INTERVENTIONAL
2005-10-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ADV + Lamivudine
Participants will receive ADV and lamivudine tablets at a dose of 10 mg orally QD for first 12 weeks followed by ADV for 60 weeks.
Adefovir dipivoxil
ADV will be administered orally at a dose of 10 mg QD for 72 weeks.
Lamivudine
Lamivudine tablets will be administered orally at a dose of 10 mg QD for 12 weeks.
Peginterferon alfa-2a + Lamivudine
Participants will receive peginterferon alfa-2a injection at a dose of 180 micrograms (mcg) once weekly (QW) and 100 milligrams (mg) lamivudine tablets orally once daily (QD) for first 12 weeks followed by peginterferon alfa-2a for 36 weeks.
Lamivudine
Lamivudine tablets will be administered orally at a dose of 10 mg QD for 12 weeks.
Peginterferon alfa-2a
Peginterferon alfa-2a injection will be administered at a dose of 180 mcg QW for 48 weeks.
Interventions
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Adefovir dipivoxil
ADV will be administered orally at a dose of 10 mg QD for 72 weeks.
Lamivudine
Lamivudine tablets will be administered orally at a dose of 10 mg QD for 12 weeks.
Peginterferon alfa-2a
Peginterferon alfa-2a injection will be administered at a dose of 180 mcg QW for 48 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hepatitis B surface antigen (HBsAg)-positive, HBeAg-positive, and anti-HBs-negative for greater than or equal to (\>=) 6 months
* Receiving lamivudine currently, and for \>=6 months
* hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) decreased \>=2 log during lamivudine treatment on \>=1 occasion
* Absence of cirrhosis confirmed by liver biopsy in previous 6 months
Exclusion Criteria
* Antiviral, anti-neoplastic, or immunomodulatory therapy less than or equal to (\<=) 6 months before study - Active infection with hepatitis A, C, or D virus, or human immunodeficiency virus
* Decompensated liver disease
* Medical condition associated with another chronic liver disease
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
Beijing, , China
Beijing, , China
Chongqing, , China
Guangzhou, , China
Hangzhou, , China
Jinan, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Hong Kong, , Hong Kong
Hong Kong, , Hong Kong
Countries
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Other Identifiers
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ML18376
Identifier Type: -
Identifier Source: org_study_id
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