A Phase 3 Study With Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects With Chronic Hepatitis C Genotype 1b Infection

CompletadoFase 3ClinicalTrials.gov

ID: NCT01581203Tipo: INTERVENTIONALInicio: 1 de may de 2012Fin estimado: 1 de sept de 2014

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to estimate 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, for subjects who are prior null or partial responders to P/R or who are treatment-naive.

Descripción detallada

Allocation: Treatment naive cohort: Randomized Controlled Trial, Null/partial responder and intolerant/ineligible cohorts: N/A (Single arm study) Masking: Treatment naive cohort: Double Blind, Null/partial responder and intolerant/ineligible cohorts: Open Intervention Model: Treatment naive cohort: Parallel, Null/partial responder and intolerant/ineligible cohorts: Single group

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Males and females, ≥ 18 years of age
HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, OR treatment naive
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

Intervenciones

drug

Asunaprevir (ASV)

drug

Daclatasvir (DCV)

drug

Pegylated-interferon alfa 2a (PegIFN)

drug

Ribavirin (RBV)

Ubicaciones

Local Institution

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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