Phase 3
Completed N=92
Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment
Source: ClinicalTrials.gov NCT01063036 ↗Enrolled (actual)
92
Serious AEs
6.5%
Results posted
Feb 2014
Primary outcomePrimary: Percentage of Participants With a Virologic Response at Week 48 - Treated Population — 76.1 percentage of participants
Summary
The purpose of this study is to show that the combination of entecavir and tenofovir, is effective and well tolerated in chronic hepatitis B patients who have failed previous treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Virologic Response at Week 48 - Treated Population |
76.1 | — |
| SECONDARY Percentage of Participants With a Virologic Response at Week 24 and at Week 96 - Treated Population |
64.1; 84.8 | — |
| SECONDARY Change From Baseline in Mean log10 HBV DNA at Weeks 12, 24, 48, and 96 - Treated Evaluable Population |
-2.230; -2.581; -2.829; -2.965 | — |
| SECONDARY Percentage of Participants With HBV DNA Less Than the Lower Limit of Detection (LLD) at Weeks 24, 48, and 96 - Treated Population |
12.0; 18.5; 16.3 | — |
| SECONDARY Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg Positive at Baseline |
3.6; 5.4; 8.9 | — |
| SECONDARY Percentage of Participants With HBe Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg-positive at Baseline |
3.6; 3.6; 1.8 | — |
| SECONDARY Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 24, 48, 96 - Treated Population Who Were HBsAg-Positive at Baseline |
1.1; 0; 2.2 | — |
| SECONDARY Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBsAg-Positive at Baseline |
1.1; 0; 1.1 | — |
| SECONDARY Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) on Treatment, and Discontinuation of Study Drug Due to Adverse Events (AE) - Treated Population |
6; 1 | — |
| SECONDARY Number of Participants With Emergence of Genotypic Resistance to Study Drugs at Weeks 48 and 96- Treated Population |
0; 0 | — |
| SECONDARY Number of Participants on Treatment With Study Drug With Laboratory Test Abnormalities Meeting Selected Criteria on Treatment - Treated Population |
9; 2; 11; 3; 4; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with chronic hepatitis B virus (HBV) infection; either hepatitis B-e antigen(HBeAg)-negative or HBeAg-positive
- Subjects must have a treatment failure to their current nucleoside/ nucleotide treatment regimen
- Prior entecavir and/or tenofovir monotherapy is allowed
- Subjects must have compensated liver function
Exclusion Criteria
- Women who are pregnant or breastfeeding
- Evidence of decompensated cirrhosis
- Co-infection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)
- Moderate or severe renal impairment
- Recent history of pancreatitis
- Therapy with interferon, thymosin alpha or other immuno-stimulators within 24 weeks of being assigned to study drug into this study
- Prior entecavir/tenofovir combination therapy
Data sourced from ClinicalTrials.gov (NCT01063036). 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.