Status:
COMPLETED
Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
16-64 years
Phase:
PHASE3
Brief Summary
This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Have compensated chronic hepatitis B.
- 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:
- Having or suspected of having liver cancer.
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00316719
Start Date
January 1 2006
End Date
January 1 2008
Last Update
October 6 2009
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