A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection
Completed · Phase 1/Phase 2
Conditions studied: Hepatitis B, Chronic
In brief
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
Key facts
- Study ID
- NCT00423891
- Run by
- Bristol-Myers Squibb
- People needed
- 64
- Starts
- 2007-06-30
- Expected to finish
- 2017-09-04
- Last updated by the study team
- 2018-05-02
Who can join
Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- University of California, San Francisco — San Francisco, California, United States
- Connecticut Children'S Medical Center — Hartford, Connecticut, United States
- University Of Florida — Gainesville, Florida, United States
- Johns Hopkins School Of Medicine — Baltimore, Maryland, United States
- Boston Childrens Hospital — Boston, Massachusetts, United States
- Mount Sinai School Of Medicine — New York, New York, United States
- Children'S Hospital Of Philadelphia — Philadelphia, Pennsylvania, United States
- Rhode Island Hospital — Providence, Rhode Island, United States
- University Of Texas Southwestern Medical Center — Dallas, Texas, United States
- Local Institution — Buenos Aires, Argentina
- Local Institution — Brussels, Belgium
- Local Institution — Porto Alegre, Rio Grande do Sul, Brazil
- Local Institution — Sco Paulo, São Paulo, Brazil
- Local Institution — Toronto, Ontario, Canada
- Local Institution — Seoul, South Korea
- Local Institution — Seoul, South Korea
- Local Institution — Taipei, Taiwan
- Local Institution — London, Greater London, United Kingdom
- Local Institution — Birmingham, West Midlands, United Kingdom
Full record on ClinicalTrials.gov
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