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A Study to Evaluate the Safety, Tolerability, and Efficacy of a 12-Week Combination Therapy of TMC647055 and TMC435 With and Without GSK2336805 With a Pharmacokinetic Enhancer With and Without Ribavir...

Mise à jour : Il y a 4 ans
Référence : EUCTR2012-002555-42

A Study to Evaluate the Safety, Tolerability, and Efficacy of a 12-Week Combination Therapy of TMC647055 and TMC435 With and Without GSK2336805 With a Pharmacokinetic Enhancer With and Without Ribavirin in Chronic Genotype-1 Hepatitis C Infected Patients

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Extrait

- Evaluate safety and tolerability of 12 weeks dosing regimen containing TMC647055 once daily (q.d.), TMC435 q.d., and RTV q.d., at selected doses with and without RBV (2 daily doses) in chronic HCV genotype 1 infected (cHCV GT1) patients - Evaluate efficacy of 12 weeks combination therapy of TMC647055 q.d., TMC435 q.d. and RTV q.d., at selected doses with RBV (2 daily doses) in treatment-naïve/prior relapser (TN/PR) cHCV GT1 patients - Evaluate efficacy of 12 weeks combination therapy of TMC647055 q.d., TMC435 q.d. and RTV q.d., at selected doses in TN/PR cHCV genotype-1b infected patients - Evaluate plasma PK of TMC647055, TMC435 and RTV of 12 weeks dosing regimen containing TMC647055 q.d., TMC435 q.d., RTV q.d., at selected doses with and without RBV (2 daily doses) - Evaluate safety, tolerability, PK and efficacy of 12 weeks combination therapy of TMC435 q.d., TMC647055 q.d., RTV q.d. and GSK2336805 q.d. without RBV, in a population of TN/PR cHCV GT1 patients

Critère d'inclusion

  • Chronic hepatitis C-infected patients

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