Phase 3
Completed N=69
Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection
Source: ClinicalTrials.gov NCT00096785 ↗Enrolled (actual)
69
Serious AEs
4.4%
Results posted
Jan 2010
Primary outcomePrimary: Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12 — -6.23; -4.52 log10 copies/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12 |
-6.23; -4.52 | — |
| SECONDARY Change From Baseline in HBV DNA by PCR Assay at Week 48 |
-7.28; -5.08 | — |
| SECONDARY Viral Load Undetectable (HBV DNA <300 Copies/mL) |
19; 6 | — |
| SECONDARY Alanine Aminotransferase (ALT) Normalization |
25; 20 | — |
| SECONDARY HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections |
99.87; 99.46; 6.07; 5.87 | — |
| SECONDARY HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Viral Clearance Rate and Infected Cell Death Rate |
1.70; 0.91; 0.08; 0.04 | — |
| SECONDARY HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Half-Life of Free Virus |
14.52; 32.46 | — |
| SECONDARY HBV DNA Viral Kinetics - Spline Model |
-0.391; -0.329; -0.034; -0.024 | — |
| SECONDARY Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths |
0; 0; 1; 3; 0; 1 | — |
| SECONDARY Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs |
1; 2; 1; 2; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic hepatitis B treatment naive
- Compensated liver disease
Data sourced from ClinicalTrials.gov (NCT00096785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.