Phase 2 N=64 Treatment

A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection

Hepatitis B, Chronic

Bottom Line

View on ClinicalTrials.gov: NCT00423891 ↗

Enrolled (actual)

Serious AEs

4.2%

Results posted

Aug 2014

Primary outcome: Primary: Number of Participants With Serious Adverse Events (SAE) and Discontinuations Due to Adverse Events (AEs) - On Treatment — 2; 0; 0; 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Entecavir (Drug)
Age: Pediatric, Adult · 2+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Serious Adverse Events (SAE) and Discontinuations Due to Adverse Events (AEs) - On Treatment	2; 0; 0; 0; 0; 0	—
SECONDARY 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	8.07; 16.03; 6.29; 19.01; 5.11; 11.32	—
SECONDARY Median Time of Maximum Observed Plasma Concentration (Tmax) in LVD-naive and LVD-experienced Participants, by Age Cohort	0.50; 1.00; 0.57; 0.72; 0.78; 0.52	—
SECONDARY 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	18.69; 42.26; 20.42; 41.50; 15.96; 35.36	—
SECONDARY Mean Apparent Total Body Clearance (CLT/F) of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort	11.40; 12.31; 22.66; 21.67; 31.92; 28.95	—
SECONDARY Number of Participants With HBV DNA Less Than 50 IU/mL Through Week 96 in Treated Participants	0; 0; 0; 1; 0; 0	—
SECONDARY Number of Participants With Hepatitis B e Antigen (HBeAg) Loss Through Week 96 in Treated Participants	0; 0; 0; 3; 0; 0	—
SECONDARY Number of Participants With Hepatitis B s Antigen (HBsAg) Loss Through Week 96 in Treated Participants	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Hepatitis B e Antigen Seroconversion Through Week 96 in Treated Participants	0; 0; 0; 3; 0; 0	—
SECONDARY Number of Participants With HBV DNA Less Than Lower Limit of Detection (LLD) for the Roche COBAS TaqMan - HPS Assay at Week 96 in Treated Participants	0; 0; 0; 1; 0; 0	—
SECONDARY Number of Participants With HBV DNA Less Than Lower Limit of Quantification (LLQ) for the Roche COBAS TaqMan - HPS Assay Through Week 96 in Treated Participants	0; 0; 0; 1; 0; 0	—
SECONDARY Number of Participants With HB s Antigen (HBsAg) Seroconversion Through Week 96 in Treated Participants	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants Who Had a Protocol Defined Response (PDR) Through Week 96 in Treated Participants	0; 0; 0; 4; 0; 0	—
SECONDARY Mean Log10 Change From Baseline in HBV DNA Using Roche COBAS TaqMan - HPS Through Week 96 in Treated Participants	-4.45; -3.89; -3.80; -5.30; -4.85; -3.89	—
SECONDARY Alanine Aminotransferase (ALT) Normalization From Baseline Through Week 96 in Treated Participants	0; 1; 2; 1; 1; 2	—
SECONDARY Number of Participants With HBV DNA by PCR Categories at Weeks 48 and 96 in Treated Participants	24; 19; 5; 14; 9; 0	—
SECONDARY Number of Participants With a Combination of ALT Normalization and HBV DNA Less Than 50 IU/mL Through Week 96 in Treated Participants	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With a Combination of ALT Normalization and HBV DNA Less Than 50 IU/mL, Plus HBeAg Seroconversion Through Week 96 in Treated Participants	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With a Combination of ALT Normalization and HBV DNA Less Than 50 IU/mL, Without HBeAg Seroconversion, Through Week 96 in Treated Participants	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Hematology Laboratory Abnormalities (Grades 1 - 4) - On Treatment - Treated Participants	1; 0; 1; 4; 3; 0	—
SECONDARY Number of Participants With Chemistry Laboratory Abnormalities (Grades 1 - 4) - On Treatment - Treated Participants	23; 17; 4; 14; 9; 1	—
SECONDARY Number of Participants With Electrolyte Laboratory Abnormalities (Grades 1 - 4) - On Treatment - Treated Participants	3; 0; 0; 1; 0; 0	—

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

Eligibility Criteria

Inclusion Criteria

2-18 years of age
Group A: Lamivudine naive ( 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00423891). 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.