A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy

CompletadoFase 2ClinicalTrials.gov

ID: NCT01170962Tipo: INTERVENTIONALInicio: 1 de ago de 2010Fin estimado: 1 de dic de 2012

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Subjects chronically infected with HCV genotype 1
Non-responder to prior therapy with peginterferon alfa and ribavirin
HCV RNA viral load of 100,00 IU/mL
Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population)
Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma
Body Mass Index (BMI) of 18 to 35 kg/m2

Criterios de exclusión

Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening
Evidence of medical condition associated with chronic liver disease other than HCV
Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

Intervenciones

drug

BMS-790052

Film coated tablet, Oral, 20 mg, once daily, 24 weeks

drug

BMS-790052

Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks

drug

Placebo

Film coated tablet, Oral, 0mg, Once daily, 24 weeks

drug

peginterferon alfa-2a

Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks

drug

ribavirin

Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks

Ubicaciones

Local Institution

Ciudad de Buenos Aires, Buenos Aires, Argentina

Local Institution

Ciudad de Buenos Aires, Buenos Aires, Argentina

Local Institution

Prov de Santa Fe, Santa Fe Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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