Phase 4
N=120
A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection
Chronic Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT00393484 ↗Enrolled (actual)
120
Serious AEs
20.0%
Results posted
Nov 2010
Primary outcome: Primary: Percentage of Participants Who Achieved a Virologic Response at Week 24 — 92.86; 67.19 Percentage of participants — p=0.0006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Entecavir (Drug); Lamivudine Placebo (Drug); Lamivudine (Drug); Entecavir Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved a Virologic Response at Week 24 |
92.86; 67.19 | 0.0006 sig |
| SECONDARY Number of Participants With Hepatitis B Virus (HBV) DNA <10^3, <10^4, or < 10^5 Copies/mL by Polymerase Chain Reaction (PCR) Assy at Weeks 24, 48, and 96 |
54; 46; 54; 53; 54; 59 | 0.0003 sig |
| SECONDARY Mean Log10 Reduction From Baseline in Hepatitis B Virus (HBV) DNA at Weeks 24, 48, 96, 144, 192, and 240 |
3.58; 2.95; 3.56; 2.65; 3.59; 2.42 | <0.0001 sig |
| SECONDARY Mean Laboratory Test Values for Alanine Aminotransferase (ALT) at Week 24 |
31.5; 43.26 | — |
| SECONDARY Number of Participants With Normalization of Serum Alanine Aminotransferase (ALT) Levels at Weeks 24, 48, and 96 |
43; 37; 48; 38; 49; 33 | 0.0278 sig |
| SECONDARY Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 24 |
0; 0; 0; 3; 0; 1 | — |
| SECONDARY Number of Participants With Elevations in Alanine Transaminase (ALT) and Aspartate Aminoaminase (AST) Levels, Elevations in ALT and AST Levels,Simultaneous Elevations in ALT and Total Bilirubin Levels, and ALT Flares at Week 24 |
0; 1; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 24 |
1; 0; 1; 2; 0; 1 | — |
| SECONDARY Number of Participants With Clinically or Statistically Significant Changes in Vital Sign Measurements at Week 24 |
0; 0 | — |
| SECONDARY Number of Participants With Virologic Rebound at Week 24 |
0; 3 | — |
| SECONDARY Percentage of Participants With a Virologic Response as Defined by Undetectable Hepatitis B Virus DNA at Weeks 48, 96, 144, 192, and 240 |
94.64; 60.94; 94.64; 48.44; 67.86; 34.38 | <0.0001 sig |
| SECONDARY Number of Participants With Viral Rebound and Drug-resistant Hepatitis B Virus (HBV) DNA Mutations at Week 96 |
1; 26; 0; 13 | <0.0001 sig |
| SECONDARY Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 240 |
7; 17; 0; 1; 48; 49 | — |
| SECONDARY Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 96 |
1; 1; 1; 0; 0; 1 | — |
Summary
Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, <300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100 mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus infection.
Eligibility Criteria
Inclusion Criteria
- Nucleoside and nucleotide-naive subjects with chronic HBV infection
- Hepatitis B Surface antigen(HBsAg)-positive ≥6 months
- Detectable HBsAg
- HBV DNA ≥ 105 copies/mL by PCR
- ALT 1.3 to 10 x the ULN
- HBeAg negative, anti-hepatitis B Virus E antigen antibody (anti-HBeAb) positive status
Data sourced from ClinicalTrials.gov (NCT00393484). 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.