A study with sofosbuvir and ribavirin for people with Hepatitis C and severe kidney disease

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-002897-30

Femme et Homme

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Extrait

The primary objectives of this study are: * To evaluate the safety of sofosbuvir (SOF) 200mg or 400mg + ribavirin (RBV) for 24 weeks as assessed by review of the accumulated safety data in each treatment arm * To evaluate the efficacy of sofosbuvir (SOF) 200mg or 400mg + ribavirin (RBV) for 24 weeks measured by the proportion of subjects with renal insufficiency who have achieved a sustained viral response 12 weeks after treatment discontinuation (SVR12) in each treatment arm * To evaluate the steady state pharmacokinetics of SOF and its metabolites upon dosing SOF 200mg or 400mg in subjects with renal insufficiency


Critère d'inclusion

  • Chronic hepatitis C virus infection