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A study to evaluate the safety and effect of three experimental drugs ABT-450, ABT-267, and ABT-333 co-administered with Ribavirin (RBV) in people that have been previously treated for Hepatitis C Vir...

Mise à jour : Il y a 4 ans
Référence : EUCTR2012-002035-29

A study to evaluate the safety and effect of three experimental drugs ABT-450, ABT-267, and ABT-333 co-administered with Ribavirin (RBV) in people that have been previously treated for Hepatitis C Virus (HCV). "Experimental" means that they have not been approved by any regulatory agency for sale to the public

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Extrait

The primary objectives of this study are to compare the percentage of subjects achieving SVR12 (HCV RNA < lower limit of quantification [LLOQ] 12 weeks following treatment) of 12 weeks of treatment with ABT-450/r/ABT-267 and ABT-333 co-administered with RBV (the DAA combination regimen) to the historical SVR rate of telaprevir plus pegIFN and RBV therapy and to assess the safety of the DAA combination regimen versus placebo for 12 weeks in pegIFN/RBV treatment-experienced HCV genotype 1-infected adults without cirrhosis.

Critère d'inclusion

  • Chronic Hepatitis C Infection

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