None listed
Conditions
Interventions
Entecavir administered in a dose of 0.5 mg once a day.
Group name:Adefovir Type of group
Adefovir in a dose of 10 mg once a day
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: History of a chronic hepatitis B infection The signing of an informed consent freely given before their participation in the clinical trial must be obtained in the subjects. Men and women with ages> 16 years.
Exclusion criteria
Exclusion criteria: Women with potential to have family who do not want or who are not able to use an acceptable method to avoid pregnancy during the entire study period and up to 8 weeks after the study. Women with the potential to have a family who use a prohibited method of contraception. Pregnant women or women who are breastfeeding. Women with a positive result in a test to diagnose pregnancy at the time of recruitment or before administering the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:test PCR Measure:Average variation in HBV DNA levels according to the Roche Amplicor PCR test Timepoints:24 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Serum creatinine level Measure:Proportion of subjects who have a confirmed increase> 0.5 mg / dL in the serum creatinine levels with respect to the initial values. Timepoints:24 week | — |
Countries
Belgium, Brazil, Finland, Germany, Greece, Israel, Korea North, Netherlands, Peru, Portugal, Singapore, South Africa, Taiwan, Thailand, United Kindgdom, United States
Outcome results
None listed