A Comparative Study of the Antiviral Efficacy and Safety of Entecavir (ETV) Versus Placebo in Pediatric Subjects With Chronic Hepatitis B Virus (HBV) Infection Who Are HBeAg-Positive

CompletadoFase 3ClinicalTrials.gov

ID: NCT01079806Tipo: INTERVENTIONALInicio: 30 de jun de 2010Fin estimado: 31 de mar de 2018

Gastroenterología Enfermedades Infecciosas Pediatría

Traducción no disponible, mostrando original

Resumen

The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B virus infection

Elegibilidad

Edad mínima: 2 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

Males and females, aged 2 to \<18 years
Hepatitis B surface antigen-positive
Detectable hepatitis B e (HBe) antigen, and no detectable anti-HBe antibodies
Alanine aminotransferase (ALT) 1.5 to \<10 times the upper limit of normal at screening and within 8 to 24 weeks prior to screening
Evidence of the presence of hepatitis B virus DNA at least 4 weeks before screening and \>100,000 copies/mL at screening

Criterios de exclusión

Any prior therapy with entecavir
At least 12 weeks of prior therapy with any nucleoside or nucleotide antiviral agent
Therapy with interferon alpha, thymosin alpha, or nucleototide antiviral agents within 24 weeks of screening
Coinfection with HIV, hepatitis C virus, or hepatitis D virus
Decompensated liver disease
Liver transplant recipients
Other forms of acute and chronic conditions which may cause increased ALT levels
Children who were breastfed while their mothers received lamivudine or whose mothers received lamivudine during pregnancy

Intervenciones

drug

Entecavir

Tablets/oral solution, 0.015 mg/kg up to 0.5 mg, administered orally, once daily, for 96 to144 weeks, depending on response

drug

Placebo

Tablets/oral solution, 0 mg, administered orally, once daily, for 48 to 96 weeks, depending on response

Ubicaciones

Local Institution

Bunos Aires, Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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