A Phase 3, Open-Label Study With Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin With Chronic Hepatitis C Genotypes 1 or 4 Infection

CompletadoFase 3ClinicalTrials.gov

ID: NCT01573351Tipo: INTERVENTIONALInicio: 1 de may de 2012Fin estimado: 1 de dic de 2013

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to assess efficacy, as determined by the proportion of subjects with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< Limit of quantitation (LOQ) at post-treatment Week 12.

Descripción detallada

* ASV = Asunaprevir (BMS-650032) * DCV = Daclatasvir (BMS-790052) * Peg = Peg-interferon Alfa-2a (PegIFN) * Rib = Ribavirin (RBV)

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Males and females, ≥ 18 years of age
HCV Genotype 1 or 4 who previously failed treatment with Peginterferon alfa-2a or peginterferon alfa-2b and Ribavirin (P/R), classified as previous null and partial responders based on previous therapy
HCV RNA ≥ 10,000 IU/mL
Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)
Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)

Criterios de exclusión

Prior treatment of HCV with HCV direct acting antiviral (DAA)
Evidence of a medical condition contributing to chronic liver disease other than HCV
Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Diagnosed or suspected hepatocellular carcinoma or other malignancies
Uncontrolled diabetes or hypertension
Total bilirubin ≥ 34 μmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease
Alanine aminotransferase (ALT) ≥ 5x Upper limit of normal (ULN)
Albumin \< 3.5 g/dL (35 g/L)
Alpha Fetoprotein (AFP) \> 100 ng/mL (\>82.6 IU/mL) or ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of Hepatocellular carcinoma (HCC) are excluded
Absolute neutrophil count (ANC) \< 1.5 x 1000,000,000 cells/L (\< 1.2 x 1000,000,000 cells/L for Black/African-Americans)
Platelets \< 90 x 1000,000,000 cells/L
Hemoglobin \< 12 g/dL for females or \< 13 g/dL for males
Any criteria that would exclude the subject from receiving P/R

Intervenciones

drug

Asunaprevir

drug

Daclatasvir

drug

Peg-interferon Alfa-2a

drug

Ribavirin

Ubicaciones

Local Institution

Ciudad de Buenos Aires, Buenos Aires, Argentina

Local Institution

Mar del Plata, Buenos Aires, Argentina

Local Institution

Prov. Buenos Aires, Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Phase 3, Open-Label Study With Asunaprevir and Daclatas... | EligiMed