A multicentre, randomized, double-blind, placebocontrolled, parallel-group phase II study on the efficacy and safety of DEB025 combined with peg-IFN alfa-2a and ribavirin in chronic hepatitis C gen...

Mise à jour : Il y a 4 ans
Référence : EUCTR2010-020033-14

A multicentre, randomized, double-blind, placebocontrolled, parallel-group phase II study on the efficacy and safety of DEB025 combined with peg-IFN alfa-2a and ribavirin in chronic hepatitis C genotype 1 patients who are previous peg-IFN alfa-2 plus ribavirin treatment-nonresponders

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Extrait

To evaluate whether the proportion of patients who achieve cEVR (by Limit of Quantitation, LOQ, i.e. HCV RNA < 25 IU/mL) after 12 weeks of triple therapy with DEB025 600 mg/day combined with peg-IFNα2a 180 μg 1x/week and RBV 1000/1200 mg/day is higher compared to the proportion of patients who achieve cEVR after 12 weeks of placebo matching DEB025 treatment plus SOC therapy consisting of peg-IFNα2a 180 μg 1x/week + RBV 1000/1200 mg/day in chronic hepatitis C GT1 patients with previous non-response to SOC.


Critère d'inclusion

  • Chronic hepatitis C