Overview

This trial is active, not recruiting.

Condition chronic hepatitis b virus, pediatric
Treatments entecavir, placebo
Phase phase 3
Sponsor Bristol-Myers Squibb
Start date June 2010
End date March 2013
Trial size 180 participants
Trial identifier NCT01079806, AI463-189 ST

Summary

The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B virus infection

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
entecavir Baraclude
Tablets/oral solution, 0.015 mg/kg up to 0.5 mg, administered orally, once daily, for 96 to144 weeks, depending on response
(Placebo Comparator)
Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
placebo
Tablets/oral solution, 0 mg, administered orally, once daily, for 48 to 96 weeks, depending on response

Primary Outcomes

Measure
Percentage of Participants Who Achieved a Combination of Hepatitis B Virus (HBV) DNA Suppression and Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48
time frame: At Week 48

Secondary Outcomes

Measure
Percentage of Participants With Hepatitis B Virus (HBV) DNA <50 IU/mL at Week 48
time frame: At Week 48
Percentage of Participants With Hepatitis B Virus DNA <Limit of Quantitation (LOQ) at Week 48
time frame: At Week 48
Percentage of Participants With Serum Alanine Aminotransferase ≤1*Upper Limit of Normal at Week 48
time frame: At Week 48
Percentage of Participants With Hepatitis B e (HBe) Seroconversion at Week 48
time frame: At Week 48
Number 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
time frame: Day 1 through Week 48 on blinded therapy
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4)
time frame: Day 1 through Week 48 on blinded therapy
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) (Continued)
time frame: Day 1 through Week 48 on blinded therapy

Eligibility Criteria

Male or female participants from 2 years up to 17 years old.

Key Inclusion Criteria - Males and females, aged 2 to <18 years - Hepatitis B surface antigen-positive - Detectable hepatitis B e (HBe) antigen, and no detectable anti-HBe antibodies - Alanine aminotransferase (ALT) 1.5 to <10 times the upper limit of normal at screening and within 8 to 24 weeks prior to screening - Evidence of the presence of hepatitis B virus DNA at least 4 weeks before screening and >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

Additional Information

Official title A Comparative Study of the Antiviral Efficacy and Safety of Entecavir (ETV) Versus Placebo in Pediatric Subjects With Chronic Hepatitis B Virus (HBV) Infection Who Are HBeAg-Positive
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.