Conditions: Hepatitis B
Keywords: lamivudine resistance Hepatitis B virus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 43
Healthy volunteers: no

Brief summary:
This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration \[FDA\] for the treatment of hepatitis B virus \[HBV\]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone.

Detailed description:

Arms:
arm 1: Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks. arm 2: Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.

Interventions: intervention 1: telbivudine intervention 2: adefovir dipivoxil
Intervention descriptions: intervention 1: 600mg/day oral tablet for 96 weeks intervention 2: 10 mg of adefovir by mouth once daily

Protocol document: