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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hepatitis B, Chronic

Treatments

Drug: Entecavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00423891

AI463-028

Details and patient eligibility

About

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

Enrollment

64 patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

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