Phase 3
Completed N=180
A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B Virus, Pediatric
Source: ClinicalTrials.gov NCT01079806 ↗
Enrolled (actual)
180
Serious AEs
7.2%
Results posted
Apr 2014
Primary outcomePrimary: Percentage of Participants Who Achieved a Combination of Hepatitis B Virus (HBV) DNA Suppression and Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 — 24.4; 2.4 Percentage of participants — p=0.0049
Summary
The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B virus infection
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved a Combination of Hepatitis B Virus (HBV) DNA Suppression and Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 |
24.4; 2.4 | 0.0049 sig |
| SECONDARY Percentage of Participants With Hepatitis B Virus (HBV) DNA <50 IU/mL at Week 48 |
46.3; 2.4 | <0.0001 sig |
| SECONDARY Percentage of Participants With Serum Alanine Aminotransferase ≤1*Upper Limit of Normal at Week 48 |
67.1; 22.0 | <0.0001 sig |
| SECONDARY Percentage of Participants With Hepatitis B Virus DNA <Limit of Quantitation (LOQ) at Week 48 |
42.7; 2.4 | <0.0001 sig |
| SECONDARY Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 (Undetectable HBeAg and Presence of Anti-HBeAb) |
24.4; 12.2 | 0.11 |
| SECONDARY Percentage of Participants Who Achieved Sustained HBeAg Seroconversion During Off-treatment Follow up Among Participants Who Achieved HBeAg Seroconversion at End of Dosing (EOD). |
100.0; 100.0; 74.4; 59.1 | — |
| SECONDARY Number of Participants With Adverse Events (Including Palatability Issues), SAEs, Discontinuous Due to Adverse Events, and HBV Disease Progression Through Week 48 |
0; 0; 4; 7; 0; 2 | — |
| SECONDARY Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) |
5; 4; 3; 2; 2; 6 | — |
| SECONDARY Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) (Continued) |
113; 59; 87; 51; 5; 6 | — |
| SECONDARY Percentage of Participants With HBeAg Seroconversion on ETV Over-time at Week 96 (All ETV Cohort) |
38.6 | — |
| SECONDARY Percentage of Participants Who Maintained HBeAg Seroconversion at Week 96 (End of Blinded Therapy) Among Participants With HBeAg Seroconversion at Week 48 |
24.2; 10.0; 36.7; 20.0 | — |
| SECONDARY Percentage of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Related AEs, Grade 2-4 Related AEs, Grade 3-4 AEs, Malignancies, ALT Flares, and Hepatic Disease Progression Through Week 96 |
0; 4.7; 0.6; 8.2; 2.3; 4.1 | — |
| SECONDARY Percentage of Participants With HBeAg Seroconversion (Undetectable HBeAg and Presence of Anti-HBeAb) up to Week 96 |
40.8 | — |
| SECONDARY Histological Analysis (Percentage) Among Participants With Available Liver Biopsy Data |
5.9 | — |
| SECONDARY Percentage of Participants With HbeAg Loss at Weeks 48 and 96 |
25.0; 10.0; 40.8 | — |
Eligibility Criteria
Key Inclusion Criteria
- Males and females, aged 2 to 100,000 copies/mL at screening
Key Exclusion Criteria
- Any prior therapy with entecavir
- At least 12 weeks of prior therapy with any nucleoside or nucleotide antiviral agent
- Therapy with interferon alpha, thymosin alpha, or nucleototide antiviral agents within 24 weeks of screening
- Coinfection with HIV, hepatitis C virus, or hepatitis D virus
- Decompensated liver disease
- Liver transplant recipients
- Other forms of acute and chronic conditions which may cause increased ALT levels
- Children who were breastfed while their mothers received lamivudine or whose mothers received lamivudine during pregnancy
Data sourced from ClinicalTrials.gov (NCT01079806). 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.