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A randomized, open-labeled study to evaluate the efficacy and safety of three experimental drugs (ABT-450, ABT-267 and ABT-333) compared with Telaprevir (a licenced product) in people with hepatitis C...

Mise à jour : Il y a 4 ans
Référence : EUCTR2012-003738-18

A randomized, open-labeled study to evaluate the efficacy and safety of three experimental drugs (ABT-450, ABT-267 and ABT-333) compared with Telaprevir (a licenced product) in people with hepatitis C virus (HCV) who have previously tried and failed other treatments. "Experimental" means that they have not been approved by any regulatory agency for sale to the public

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Extrait

The primary objective of this study is to assess the efficacy (the percentage of subjects achieving 12-week sustained virologic response, SVR12, [HCV RNA < LLOQ 12 weeks post-treatment]) and safety of ABT-450/r/ABT-267 and ABT-333 co-administered with RBV for 12 weeks compared to 12 weeks of treatment with telaprevir and pegIFN/RBV followed by either 12 weeks or 36 weeks of pegIFN/RBV, per local prescribing information, in treatment-experienced HCV genotype 1-infected adults.

Critère d'inclusion

  • Chronic Hepatitis C Infection

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