A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFNα2a and Ribavirin in Hepatitis C Genotype 1 Treatment-naïve Patients

CompletadoFase 3ClinicalTrials.gov

ID: NCT01318694Tipo: INTERVENTIONALInicio: 1 de mar de 2011Fin estimado: 1 de ago de 2013

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy \[i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)\] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Chronic HCV infection
HCV genotype 1
No previous treatment for hepatitis C infection
Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit
Liver evaluation prior to baseline: liver biopsy within 3 years or Fibroscan within 6 months

Criterios de exclusión

HCV genotype different from genotype 1 or co-infection with other HCV genotype
Co-infection with Hepatitis B or HIV
Any other cause of relevant liver disease other than HCV
Presence or history of hepatic decompensation
Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN), more than 1 episode of elevated bilirubin (\> ULN) in past 6 months

Intervenciones

drug

Alisporivir

ALV 200 mg soft gel capsules administered orally

drug

Peginterferon alfa-2a

PEG 180 μg administered via subcutaneous (s.c.) injection once weekly

drug

Ribavirin

RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose

drug

ALV Placebo

ALV placebo soft gel capsules administered orally

Ubicaciones

Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalDebiopharm International SA

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