Status:
COMPLETED
A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
2-18 years
Phase:
PHASE1
PHASE2
Brief 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
- 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
- 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
Key Trial Info
Start Date :
June 30 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2017
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00423891
Start Date
June 30 2007
End Date
September 4 2017
Last Update
May 2 2018
Active Locations (19)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Connecticut Children'S Medical Center
Hartford, Connecticut, United States, 06106
3
University Of Florida
Gainesville, Florida, United States, 32610
4
Johns Hopkins School Of Medicine
Baltimore, Maryland, United States, 21287