Chronic Hepatitis B
Conditions
Brief summary
The purpose of this study is to find out if taking a combination of telbivudine and adefovir or tenofovir and telbivudine can lower the amount of Hepatitis B virus in patients that have been taking adefovir alone for at least 5 months and have had less than optimal responses. The safety of taking telbivudine and adefovir together or tenofovir and telbivudine together will also be studied.
Interventions
DRUGTelbivudine
Study cancelled: Withdrawn before enrollment of any participants
DRUGAdefovir
DRUGTenofovir
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Inclusion criteria
* Documented compensated chronic hepatitis B defined by clinical history compatible with chronic hepatitis B * Patient is currently receiving Hepsera (adefovir dipivoxil) and has received treatment continuously for a minimum of 5 months prior to screening. Other inclusion criteria may apply.
Exclusion criteria
* Patient is pregnant or breastfeeding * Patient is co-infected with hepatitis C, hepatitis D or HIV * Patient previously received nucleoside(tide) therapy other than adefovir * Patient previously received an interferon-based treatment or an investigational agent for hepatitis B in the preceding 12 months Other
Outcome results
None listed