Phase 3
N=105
Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients
Chronic Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT00316719 ↗Enrolled (actual)
105
Serious AEs
3.8%
Results posted
Aug 2009
Primary outcome: Primary: Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52 — -3.69; -3.40 log10 copies/mL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- LAM group (Drug); ADV group (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52 |
-3.69; -3.40 | <0.001 sig |
| SECONDARY Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52 |
46.0; 50.0; 54.0; 50.0 | — |
| SECONDARY Time to Onset of HBV DNA Loss (< 400 Copies/mL) |
— | — |
| SECONDARY Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52 |
16.7; 16.2; 93.3; 93.8 | — |
| SECONDARY Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52 |
9.7; 5.9; 90.3; 94.1 | — |
| SECONDARY Time to Onset of HBeAg Loss |
— | — |
| SECONDARY Time to Onset of HBeAg/Ab Seroconversion |
— | — |
| SECONDARY Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52 |
0.0; 0.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52 |
0.0; 0.0; 100.0; 100.0 | — |
| SECONDARY Mean Alanine Aminotransferase (ALT) Level at Week 52 |
32.3; 33.0 | — |
| SECONDARY Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52 |
82.6; 78.4; 17.4; 21.6 | — |
| SECONDARY Time to Onset of ALT Normalization |
12.0; 12.0 | — |
| SECONDARY Rate of Emergence of Resistant Virus at Week 52 |
0; 28.8; 100; 71.2 | — |
Summary
This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.
Eligibility Criteria
Inclusion criteria
- Have compensated chronic hepatitis B.
- Have not been treated with anti HBV agents with antiproliferative activity against. However, previous Interferon (IFN) therapy is permitted.
- Ability to read, understand, and sign the informed consent.
- Have a positive serum HBV-DNA >= 1,000,000 copies/mL and ALT level 50-500 U/L
Exclusion criteria
- Having or suspected of having liver cancer.
- Co-infected with Hepatitis C virus (HCV) or Human Immunodeficiency virus (HIV).
- Autoimmune hepatitis.
- Received any previous transplantation or having a plan for any transplantation.
- Existence of any serious complication, except hepatitis B.
Data sourced from ClinicalTrials.gov (NCT00316719). 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.