Randomized, Open-Label, Comparative Study to Evaluate Early Viral Load Reductions and Exploratory Viral Kinetics Following Administration of Entecavir or Adefovir in Nucleoside-Naive Adults With Chronic Hepatitis B Infection

Bristol-Myers Squibb2 sites in 2 countries69 target enrollmentDecember 2004

ConditionsHepatitis B Chronic Disease

Interventionsentecavir adefovir

Drugsentecavir adefovir

Overview

Phase: Phase 3
Intervention: entecavir
Conditions: Hepatitis B
Sponsor: Bristol-Myers Squibb
Enrollment: 69
Locations: 2
Primary Endpoint: Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.

Registry

clinicaltrials.gov

Start Date

December 2004

End Date

April 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Eligibility Criteria

Inclusion Criteria

•Chronic hepatitis B treatment naive
•Compensated liver disease

Exclusion Criteria

Not provided

Arms & Interventions

A1

Intervention: entecavir

A2

Intervention: adefovir

Outcomes

Primary Outcomes

Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12

Time Frame: Baseline, Week 12

Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR (log10 copies/mL) at Week 12, adjusted for baseline (Week 12 - baseline). A negative value = improvement.

Secondary Outcomes

Change From Baseline in HBV DNA by PCR Assay at Week 48(Baseline, Week 48)
Viral Load Undetectable (HBV DNA <300 Copies/mL)(Week 48)
Alanine Aminotransferase (ALT) Normalization(Week 48)
HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections(Week 12)
HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Viral Clearance Rate and Infected Cell Death Rate(Week 12)
HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Half-Life of Free Virus(Week 12)
HBV DNA Viral Kinetics - Spline Model(Week 12)
Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths(cumulative through the end of on-treatment observation as available at the time of the Week 48 dataset)
Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs(Week 48)