An Open-Label Re-Treatment Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C

CompletadoFase 2ClinicalTrials.gov

ID: NCT01428063Tipo: INTERVENTIONALInicio: 1 de sept de 2011Fin estimado: 1 de dic de 2014

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.

Descripción detallada

* Intervention Model: * Parallel: for all patients entering the trial * Cross-over: for genotype 1b patients rolling over from NCT01428063 (AI447-028) who require rescue therapy after initial treatment in this study * Peginterferon alfa-2a * Ribavirin * Daclatasvir * Asunaprevir

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Prior participation in any BMS-790052, BMS-650032, or BMS-791325 trial and assigned to control arm (pegIFNα-2a/ribavirin + placebo) during the trial
Hepatitis C virus (HCV) genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)
HCV RNA viral load detectable

Criterios de exclusión

Discontinuation from a prior BMS HCV clinical trial due to a pegIFNα-2a/ribavirin-related event
Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052, or BMS-791325
Positive for hepatitis B infection (hepatitis B surface antigen) or HIV-1 or HIV-2 antibody at screening
Evidence of medical condition associated with chronic liver disease other than HCV infection
Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

Intervenciones

drug

Daclatasvir

drug

Asunaprevir

drug

Pegylated interferon alfa-2a

drug

Ribavirin

Ubicaciones

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

Prov. Buenos Aires, Buenos Aires, Argentina

Local Institution

Prov de Santa Fe, Santa Fe Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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