A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection
Status: | Completed |
---|---|
Conditions: | Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 2 - 18 |
Updated: | 5/4/2018 |
Start Date: | June 30, 2007 |
End Date: | September 4, 2017 |
Evaluation of the Pharmacokinetics, Safety, Tolerability and Efficacy of Entecavir (ETV) in Pediatric Subjects With Chronic Hepatitis B Virus (HBV) Infection Who Are HBeAg-Positive
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
in children and adolescents. Safety, tolerability and efficacy will also be studied
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
We found this trial at
10
sites
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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