Phase 4
Completed N=166
Suboptimal Responders to Adefovir Switching to Entecavir
Hepatitis B, Chronic
Source: ClinicalTrials.gov NCT00718887 ↗
Enrolled (actual)
166
Serious AEs
0.6%
Results posted
Feb 2013
Primary outcomePrimary: Percentage of Participants Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing — 5.6; 0.0 Percentage of participants
Summary
Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing |
5.6; 0.0 | — |
| SECONDARY Percentage of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 48 by Polymerase Chain Reaction Testing |
31.5; 28.6 | — |
| SECONDARY Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing |
-2.5; -0.2; -3.3; -3.2 | — |
| SECONDARY Percentage of Participants Who Achieved Normalization of Alanine Aminotransferase (ALT) |
31.4; 22.2; 60.8; 47.2 | — |
| SECONDARY Percentage of Participants With Loss of Hepatitis B e Antigen (HBeAg) and Hepatitis B e (HBe) Seroconversion |
3.8; 6.9; 7.6; 6.9; 2.5; 1.45 | — |
| SECONDARY Number of Participants With Hepatitis B s Surface Antibody (HBsAG) Loss and HBsAG Seroconversion |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Genotypic Resistance to Entecavir |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Adverse Events, Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, Death as Outcome, Discontinuations Due to AEs, and Abnormalities in Laboratory Test Results (LTR) Leading to Discontinuation |
16; 7; 0; 0; 1; 0 | — |
| SECONDARY Percentage of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results |
9; 5.2; 2.2; 0; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic infection with hepatitis B virus (HBV)(detectable hepatitis B surface antibody (HBsAg) at screening and at least 24 weeks prior to screening, or detectable HBsAg for 1.5 mg/dL; hemoglobin level 100 ng/mL
- Except adefovir, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (eg, lamivudine, entecavir), or any other experimental anti-HBV antiviral, or any China Traditional Medicine
- Therapy with interferon, thymosin alpha, or other immunostimulators within 24 weeks of randomization
- Required chronic administration of medications that cause immunosuppression, that are associated with a high risk of nephrotoxicity or hepatotoxicity, or that affect renal excretion.
Data sourced from ClinicalTrials.gov (NCT00718887). 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.