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A Phase IV, Randomised, Multicentre, Efficacy and Safety Study Examining the Effect of Induction Dosing With the Combination of Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Infected With Hepatitis C Genotype 1

CompletadoFase 4ClinicalTrials.gov

ID: NCT00192647Tipo: INTERVENTIONALInicio: 1 de ago de 2004Fin estimado: 1 de mar de 2009

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

This study will evaluate the addition of a higher-dose induction treatment period with peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive participants with CHC, genotype 1 infection.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Diagnosis of chronic CHC, genotype 1
Chronic liver disease consistent with CHC on a biopsy sample obtained within the previous 36 months as judged by a local pathologist (all countries except Australia)
Infection with Hepatitis C virus (Australian sites only had to meet Section 100 criteria for treatment with PEG-IFN alfa-2a plus ribavirin)
Compensated liver disease
Naive to interferon-based therapy for CHC infection

Criterios de exclusión

Systemic antiviral, antineoplastic, or immunomodulatory treatment within 6 months of study drug
Coinfection with active hepatitis A or B virus, or with human immunodeficiency virus (HIV)
Chronic liver disease other than CHC infection

Intervenciones

drug

PEG-IFN alfa-2a

PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.

drug

Ribavirin

Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.

Ubicaciones

Buenos Aires, Argentina

La Plata, Argentina

Rosario, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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