Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.
Terminated
Gilead Sciences
N/A
2002-01-01
Provide adefovir dipivoxil (Hepsera) 10 mg once daily to patients with chronic hepatitis B
virus (HBV) infection who have completed a Gilead-sponsored study of adefovir dipivoxil and
require continued access to adefovir dipivoxil.
Observational Study of the Durability of Seroconversion Chronic HBV Patients Who Seroconverted in a Previous Gilead-Sponsored Study of ADV.
Completed
Gilead Sciences
2003-04-01
To investigate the durability of HBeAg seroconversion in patients with chronic hepatitis B
virus infection (HBV) who have seroconverted while participating in a previous
Gilead-sponsored study of adefovir dipivoxil.
Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT
Completed
Gilead Sciences
Phase 4
2003-04-01
This project is a randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine
combination therapy versus adefovir dipivoxil (Hepsera) monotherapy. Both adefovir dipivoxil
and lamivudine are nucleoside analogues approved by the U.S. FDA for the treatment of chronic
hepatitis B.
The primary hypothesis is that subjects treated with combination therapy will see their viral
DNA count decrease in an amount greater than subjects treated with monotherapy. The secondary
hypothesis is that subjects treated with combination therapy will have a higher HBeAg
conversion rate compared to historical controls of subjects treated with lamivudine or
adefovir dipivoxil monotherapy.
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