A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Post-liver or Post-kidney transplant with Chronic Hepatitis C Virus

Mise à jour : Il y a 4 ans
Référence : EUCTR2015-005616-14

Femme et Homme

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Extrait

The primary objectives of this study are to compare the 12-week sustained virologic response, SVR12 (HCV RNA < LLOQ 12 weeks following therapy) of 12 weeks of treatment with the ABT-493/ABT-530 combination regimen in adults with HCV genotype 1 – 6 infection who are post primary orthotopic liver transplant or renal transplant to a pre-defined threshold, based on the historical SVR12 rates for the current standard of care regimens (sofosbuvir/ledipasvir plus ribavirin or sofosbuvir plus daclatasvir plus RBV) and to assess the safety of treatment with the ABT-493/ABT-530 combination regimen for 12 weeks in adults with HCV genotype GT1 – 6 infection and post primary orthotopic liver transplant or renal transplant.


Critère d'inclusion

  • HEPATITIS C VIRUS