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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...

Update Il y a 4 ans
Reference: EUCTR2012-003754-84

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 not had treatment before. "Experimental" means that they have not been approved by any regulatory agency for sale to the public

Woman and Man

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Extract

The primary objectives of this study are to demonstrate that treatment with ABT-450/r/ABT-267 and ABT-333 administered with or without RBV has non-inferior efficacy (the percentage of subjects achieving SVR12, HCV RNA < LLOQ 12 weeks following treatment) compared to treatment with telaprevir and pegIFN/RBV and to compare the safety of the regimens in treatment-naive HCV genotype (GT) 1a- and 1b-infected adults without cirrhosis.

Inclusion criteria

  • Chronic Hepatitis C Infection

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