Overview

This trial is active, not recruiting.

Condition hepatitis b, chronic
Treatment entecavir
Phase phase 1/phase 2
Sponsor Bristol-Myers Squibb
Start date June 2007
End date August 2013
Trial size 64 participants
Trial identifier NCT00423891, AI463-028

Summary

The purpose of this clinical study is to determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
entecavir Baraclude
Tablets / Oral Solution, Oral, Naïve: 0.015 mg/kg up to 0.5 mg; Experienced: 0.030 mg/kg up to 1 mg, once daily, 48 - 120 weeks depending on response

Primary Outcomes

Measure
Mean Maximum Observed Plasma Concentration (Cmax) and Mean Trough Observed Plasma Concentration (Cmin) of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort
time frame: Day 14
Median Time of Maximum Observed Plasma Concentration (Tmax) in LVD-naive and LVD-experienced Participants, by Age Cohort
time frame: Day 14
Mean Area Under the Concentration-Time Curve in One Dosing Interval [AUC(TAU)] of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort
time frame: Day 14
Mean Apparent Total Body Clearance (CLT/F) of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort
time frame: At 2 weeks
Number of Participants With Serious Adverse Events (SAE) and Discontinuations Due to Adverse Events (AEs) - On Treatment
time frame: Day 1 to Week 120

Secondary Outcomes

Measure
Number of Participants With HBV DNA Less Than 50 IU/mL Through Week 48 (Non-Completer=Failure) in Treated Participants
time frame: Baseline to Week 48
Number of Participants With Hepatitis B e Antigen (HBeAg) Loss Through Week 48 (Non-Completer=Failure) in Treated Participants
time frame: Baseline to Week 48
Number of Participants With Hepatitis B s Antigen (HBsAg) Loss Through Week 48 (Non-Completer=Failure) in Treated Participants
time frame: Baseline to Week 48
Number of Participants With Hepatitis B e Antigen Seroconversion Through Week 48 (Non-Completer=Failure) in Treated Participants
time frame: Baseline through Week 48
Number of Participants With HBV DNA Less Than Lower Limit of Detection (LLD) for the Roche COBAS TaqMan - HPS Assay (Non-Completer=Failure) at Week 48 in Treated Participants
time frame: Baseline to Week 48
Number of Participants With HBV DNA Less Than Lower Limit of Quantification (LLQ) for the Roche COBAS TaqMan - HPS Assay (Non-Completer=Failure) Through Week 48 in Treated Participants
time frame: Baseline through Week 48
Number of Participants With HB s Antigen (HBsAg) Seroconversion Through Week 48 (Non-Completer=Failure) in Treated Participants
time frame: Baseline through Week 48
Number of Participants Who Had a Protocol Defined Response (PDR) Through Week 48 (Non-Completer=Failure) in Treated Participants
time frame: Baseline to Week 48
Mean Log10 Change From Baseline in HBV DNA Using Roche COBAS TaqMan - HPS Through Week 48 in Treated Participants
time frame: Baseline to Week 48
Alanine Aminotransferase (ALT) Normalization From Baseline Through Week 48 (Non-Completer=Failure) in Treated Participants
time frame: Baseline to Week 48
Number of Participants With HBV DNA by PCR Categories (Non-Completer=Failure) at Week 48 in Treated Participants
time frame: Baseline, Week 48
Number of Participants With a Combination of ALT Normalization and HBV DNA Less Than 50 IU/mL Through Week 48 (Non-Completer=Failure) in Treated Participants
time frame: Baseline to Week 48
Number of Participants With a Combination of ALT Normalization and HBV DNA Less Than 50 IU/mL, Plus HBeAg Seroconversion Through Week 48 (Non-Completer=Failure) in Treated Participants
time frame: Baseline to Week 48
Number of Participants With a Combination of ALT Normalization and HBV DNA Less Than 50 IU/mL, Without HBeAg Seroconversion, Through Week 48 (Non-Completer=Failure) in Treated Participants
time frame: Baseline to Week 48
Number of Participants With Hematology Laboratory Abnormalities (Grades 1 - 4) - On Treatment - Treated Participants
time frame: Day 1 to Week 120
Number of Participants With Chemistry Laboratory Abnormalities (Grades 1 - 4) - On Treatment - Treated Participants
time frame: Day 1 to Week 120
Number of Participants With Electrolyte Laboratory Abnormalities (Grades 1 - 4) - On Treatment - Treated Participants
time frame: Day 1 Week 120

Eligibility Criteria

Male or female participants from 2 years up to 18 years old.

Inclusion Criteria: - 2-18 years of age - Group A: Lamivudine naive (<1 week of Lamivudine) and not within 24 weeks of screening; Group B: Lamivudine experienced (> 12 weeks of Lamivudine); Group C: nucleoside/nucleotide experienced (> 12 weeks of nucleoside/tide therapy) added as a country-specific protocol amendment (not all sites had Group C). - HBV Deoxyribonucleic acid (DNA) ≥ 100000 copies/mL; ≥ 10000 copies for nucleoside/nucleotide experienced (Group C) - Detectable Hepatitis B surface antigen (HBsAg) for 24 weeks prior to screening - Hepatitis B e antigen (HBeAg) positive - Compensated liver and renal function - Elevated alanine aminotransferase (ALT) at screening and during the 24 weeks prior to screening (for Groups A and B) Exclusion Criteria: - Coinfection with Human immunodeficiency virus (HIV), Hepatitis C virus (HCV), Hepatitis D Virus (HDV) - Children who were breastfed while their mother received Lamivudine, or children whose mothers received Lamivudine during pregnancy

Additional Information

Official title Evaluation of the Pharmacokinetics, Safety, Tolerability and Efficacy of Entecavir (ETV) 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.