Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C

CompletadoFase 3ClinicalTrials.gov

ID: NCT00093093Tipo: INTERVENTIONALInicio: 1 de jun de 2004Fin estimado: 1 de may de 2006

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before received treatment.

Descripción detallada

Compare the efficacy and safety of viramidine 600 mg twice a day (BID) versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2a to treatment-naive patients with chronic hepatitis C (CHC)

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Treatment-naive patients with compensated chronic hepatitis C.
HCV RNA \>2000 copies/mL (780 IU/mL) as determined by NGI SuperQuant serum HCV RNA quantification, with a lower limit of detection of 100 copies/mL (39 IU/mL).

Criterios de exclusión

Severe neuropsychiatric disorders
History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease
Pregnant or breast-feeding patients

Intervenciones

drug

Viramidine

drug

Ribavirin

drug

pegylated interferon alfa-2a

Ubicaciones

Hospital Italiano

Buenos Aires, Buenos Aires, Argentina

Fundación CIDEA

Buenos Aires, Buenos Aires, Argentina

Hospital Británico

Buenos Aires, Buenos Aires, Argentina

Hospital Austral

Pilar, Buenos Aires, Argentina

Hospital Centenario

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalBausch Health Americas, Inc.

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