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

CompletadoFase 2ClinicalTrials.gov

ID: NCT00423891Tipo: INTERVENTIONALInicio: 30 de jun de 2007Fin estimado: 4 de sept de 2017

Gastroenterología Enfermedades Infecciosas Pediatría

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 2 YearsEdad máxima: 18 YearsSexo: ALL

Criterios de inclusión

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)

Criterios de exclusión

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

Intervenciones

drug

Entecavir

Tablets / Oral Solution, Oral, Naïve: 0.015 mg/kg up to 0.5 mg; Experienced: 0.030 mg/kg up to 1 mg, once daily, 48 - 120 weeks depending on response

Ubicaciones

Local Institution

Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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