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An open-label study to evaluate the safety and efficacy of three experimental drugs (Ombitasvir/ ABT-450/ Ritonavir and Dasabuvir) in people with genotype 1b hepatitis C virus (HCV) and early liver da...

Mise à jour : Il y a 4 ans
Référence : EUCTR2014-001953-18

An open-label study to evaluate the safety and efficacy of three experimental drugs (Ombitasvir/ ABT-450/ Ritonavir and Dasabuvir) in people with genotype 1b hepatitis C virus (HCV) and early liver damage. "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 efficacy (the percentage of subjects achieving a 12-week sustained virologic response, SVR12 [HCV RNA < lower limit of quantification (LLOQ) 12 weeks following treatment]) of co-formulated ombitasvir/ABT-450/ritonavir and dasabuvir administered for 12 weeks to the historical SVR12 rate of sofosbuvir plus pegIFN/RBV and to assess the safety of the DAA combination regimen in HCV genotype 1b-infected adult subjects with compensated cirrhosis.

Critère d'inclusion

  • Chronic Hepatitis C Infection and compensated cirrhosis

Liens