None listed
Conditions
Interventions
Entecavir oral (1.0 mg once daily) administered once a day will be administered.
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: Men and women> 16 years of age - Failed adefovir therapy (ie, experienced viremia according to the definition of AI463048 protocol:> 104 copies / ml of HBV serum DNA using the PCR technique and a reduction 2 logio from baseline in the serum DNA of the HBV determined by the PCR technique, with persistence of HBeAg in subjects with positive results in the visit baseline and / or abnormal ALT (> 1.25 X ULN)) after completing 96 weeks of therapy.
Exclusion criteria
Exclusion criteria: • Concomitant infection by human immunodeficiency virus (HIV). • Therapy with nephrotoxic agents (excluding immunosuppressive agents in transplant recipients) or hepatotoxic agents, such as aminoglycosides, amphotericin B, foscamet, carbamazepine. • Hemoglobin <11.0 g / dl (<110 g / 1) except for those coming from study AI463048. For AI463048 subjects, cases with hemoglobin <8.0 g / dl (<80 g / 1) should be consulted with the Medical Monitor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Safety, measured according to the incidence of adverse clinical events and laboratory abnormalities. Measure:Measure the safety of Entecavir in patients with hepatitis B Timepoints:Weeks 2 and 4, and every 4 weeks during the treatment period until Week 96, then every 8 weeks during the treatment beyond Week 96. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:reduction of> 2 points in the modified HAI scale of Knodell, central antigen of HBV and / or DNA and toxic effects Measure:Improvement of histological activity, reduction of HBV core antigen and / or DNA and evaluation of toxic effects combined with entecavir and lamivudine in liver biopsy. Timepoints:Weeks 2 and 4, and every 4 weeks during the treatment period until Week 96, then every 8 weeks during the treatment beyond Week 96. | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Indonesia, Ireland, Israel, Italy, Korea North, Malasya, Mexico, Netherlands, Norway, Pakistan, Philippines, Poland, Portugal, Russian Federation, Singapore, Slovakia, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kindgdom
Outcome results
None listed