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

• Status: Completed
• Trial end date: 2017-09-04
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Entecavir

Criteria

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