None listed
Conditions
Interventions
Entecavir 0.01 mg Type of group
0.01 mg capsule orally 2 hours before or 2 hours after food once daily for 24 weeks.
Group name:Lamivudine 100 mg Type of group
Capsule 100 mg orally once a day for 24 weeks. After week 24 if there is a partial response to therapy or relapse of therapy, participants will receive the same dose of lamivudine until a full response is obtained or until week 48.
Sponsors
BRISTOL MYERS SQUIBB PERÚ S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Males and females ≥16 years of age with chronic hepatitis B (or the minimum age required for participation in a given country, whichever is higher). • Documentation of HBsAg positive in serum for ≥ 24 weeks prior to randomization. • Both HBeAg positive and HBeAg negative subjects are eligible. Those subjects who are positive for HBeAg must have been documented to be positive for ≥ 12 weeks prior to randomization; subjects negative for HBeAg must also be positive for e antibody. • Positive HBV DNA assay with valué > 40 MEq/mL (143 pg/mL) by the Chiron bDNA hybridization assay) on 2 determinations drawn at least 2 weeks apart. • ALT (SGPT) in the range of normal to 10 x ULN. • Total serum bilirubin ≤ 2.5 mg/dL (< 42.75 µmol/L). • Prothrombin time ≤ 3 seconds longer than normal control value or INR ≤ 2.23.
Exclusion criteria
Exclusion criteria: • Coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV). • Decompensated liver disease (i.e., hepatic encephalopathy, significant ascites, bleeding varices). • Prior therapy with adefovir, lamivudine or lobucavir of > 12 weeks duration. • These drugs must have been stopped at least 24 weeks prior to randomization into this study. • Therapy with alpha interferon or thymosin alpha-1 within 24 weeks prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:measured by the Roche PCR assay Measure:Mean log10 HBV DNA for each entecavir dose compared to lamivudine. Timepoints:at Week 22 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:incidence of clinical adverse events and laboratory abnormalities in each entecavir group in comparison with lamivudine Measure:incidence of clinical adverse events Timepoints:will be recorded throughout the study ; Outcome name:Log10 HBV DNA levels by Roche PCR assay Measure:Dose-response relationship for each entecavir dose group Timepoints:At Week 12 at the time of the interim analysis ; Outcome name:PCR method (400 copies/mL limit of detection) Measure:Proportion of subjects who achieve undetectable HBV DNA levels Timepoints:At weeks 12 and 22 ; Outcome name:Chiron assay (limit of detection 2.5 pg/mL or 0.7 MEq/mL) Measure:Proportion of subjects with undetectable HBV DNA Timepoints:At Week 22 | — |
Outcome results
None listed