Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT
Status:
Completed
Trial end date:
2007-08-01
Target enrollment:
Participant gender:
Summary
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.