A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, With and Without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naïve Genotype 2 and 3 Chronic Hepatitis C Subjects

CompletadoFase 3ClinicalTrials.gov

ID: NCT01616524Tipo: INTERVENTIONALInicio: 1 de jul de 2012Fin estimado: 1 de sept de 2014

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Chronic hepatitis C, Genotype 2 or 3
Naïve to prior anti-HCV therapy

Criterios de exclusión

Infected with HCV other than Genotype 2 or 3
Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
Evidence of liver disease other than HCV
Active substance abuse
Evidence of decompensated cirrhosis

Intervenciones

biological

Pegylated interferon lambda (pegIFNλ)

Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks

biological

Pegylated interferon lambda (pegIFNλ)

Syringe, Subcutaneous, 180 μg, Once weekly, 12 weeks

biological

Pegylated interferon alfa-2a (pegIFNα-2a)

Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks

drug

Ribavirin

Tablets, Oral, 400 mg, Twice daily, 24 weeks

drug

Ribavirin

Tablets, Oral, 400 mg, Twice daily, 12 weeks

drug

Daclatasvir

Tablets, Oral, 60 mg, Once daily, 12 weeks

drug

Placebo matching Daclatasvir

Tablets, Oral, 0 mg, Once daily, 12 weeks

Ubicaciones

Local Institution

Autonoma, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Ciudad de Buenos Aires, Buenos Aires, Argentina

Local Institution

Ciudad de Buenos Aires, Buenos Aires, Argentina

Local Institution

Mar del Plata, Buenos Aires, Argentina

Local Institution

Quilmes, Buenos Aires, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

Prov de Santa Fe, Santa Fe Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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