.A.

Not Applicable

• Conditions: -B18 Chronic viral hepatitis; Chronic viral hepatitis; B18

• Registration Number: PER-017-99
• Lead Sponsor: BRISTOL MYERS SQUIBB PERÚ S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1999-11-04
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:measured by the Roche PCR assay<br>Measure:Mean log10 HBV DNA for each entecavir dose compared to lamivudine.<br>Timepoints:at Week 22<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:incidence of clinical adverse events and laboratory abnormalities in each entecavir group in comparison with lamivudine<br>Measure:incidence of clinical adverse events<br>Timepoints:will be recorded throughout the study<br>;<br>Outcome name:Log10 HBV DNA levels by Roche PCR assay<br>Measure:Dose-response relationship for each entecavir dose group<br>Timepoints:At Week 12 at the time of the interim analysis<br>;<br>Outcome name:PCR method (400 copies/mL limit of detection)<br>Measure:Proportion of subjects who achieve undetectable HBV DNA levels<br>Timepoints:At weeks 12 and 22<br>;<br>Outcome name:Chiron assay (limit of detection 2.5 pg/mL or 0.7 MEq/mL)<br>Measure:Proportion of subjects with undetectable HBV DNA<br>Timepoints:At Week 22<br>