Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients
NCT ID: NCT00316719
Last Updated: 2009-10-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
105 participants
INTERVENTIONAL
2006-01-31
2008-01-31
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
QUADRUPLE
Study Groups
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Adefovir Dipivoxil (ADV)
ADV group
Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.
Lamivudine (LAM)
LAM group
Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily.
Interventions
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LAM group
Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily.
ADV group
Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have not been treated with anti HBV agents with antiproliferative activity against. However, previous Interferon (IFN) therapy is permitted.
* Ability to read, understand, and sign the informed consent.
* Have a positive serum HBV-DNA \>= 1,000,000 copies/mL and ALT level 50-500 U/L
Exclusion Criteria
* Co-infected with Hepatitis C virus (HCV) or Human Immunodeficiency virus (HIV).
* Autoimmune hepatitis.
* Received any previous transplantation or having a plan for any transplantation.
* Existence of any serious complication, except hepatitis B.
16 Years
64 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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GSK
Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Other Identifiers
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ADF105220
Identifier Type: -
Identifier Source: org_study_id
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