A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients with Recurrent Chronic Hepatitis C Genotype 1b Infection after Orthotopic Liver Transplantation Un estudio de farmacocinética, eficacia, seguridad, tolerabilidad de la combinación de Simeprevir (TMC435), daclatasvir (BMS-790052) y ribavirina (RBV) en pacientes con hepatitis C crónica recurrente genotipo 1b infección tras el trasplante hepático ortotópico The primary objectives are: - To evaluate the effect of steady-state simeprevir and daclatasvir on the steady-state pharmacokinetics of cyclosporine and tacrolimus when administered as a regimen conta...

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TMC435HPC3002 - 3-Year Follow up of Patients After Administration of TMC435 for the Treatment of Chronic Hepatitis C - To evaluate the durability of sustained virologic response (SVR) in subjects who were treated with a TMC435- containing regimen in a previous Phase IIb or Phase III study and maintained undetectable...

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TMC435-TiDP16-C208 - Phase III Trial of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients To demonstrate the superiority of TMC435 versus placebo as part of a treatment regimen including peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), with respect to the proportion of subjects with...

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A Phase I, open label, randomized, crossover trial in healthy subjects to investigate the effect of steady-state TMC278 on the pharmacokinetics of a single dose of digoxin To investigate the effect of steady-state TMC278 on the single dose PK of digoxin.

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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 Ribavirin in Chronic Genotype-1 Hepatitis C Infected Patients - 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 g...

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Trial to study the pharmacokinetics and food effect of solid and liquid formulations of TMC435 versus the reference • To compare the rate and extent of absorption of TMC435 following administration of a single dose of 2 different liquid formulations to that following administration of a single dose of the Phase III...

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roll-over trial for continued TMC278 access The primary objective of the trial is to provide continued access to TMC278 for subjects who were randomized and treated with TMC278 in the Phase IIb (C204) or Phase III trials (C209 and C215), and wh...

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An Efficacy, Safety, Tolerability and Pharmacokinetics Study of 12 Weeks Treatment With Simeprevir and Daclatasvir in Participants With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis Estudio de eficacia, seguridad, tolerabilidad y farmacocinética de 12 semanas de tratamiento con Simeprevir y Daclatasvir en pacientes con infección crónica por el genotipo 1b o 4 del virus de la hepatitis C y con disfunción renal grave o enfermedad renal terminal en hemodiálisis The primary objective is to evaluate the efficacy (SVR12) of a 12-week treatment regimen containing SMV and DCV in subjects with chronic HCV genotype 1b or 4 infection and either severe renal impairme...

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TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy To demonstrate the non-inferiority of TMC435 versus TVR, both given in combination with PegIFNα-2a and RBV, by less than 12%, with respect to the proportion of subjects with SVR 12 weeks after the pla...

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TMC435-TiDP16-C212 - Trial of TMC435 in Genotype 1 Hepatitis C and Human Immunodeficiency Virus Co-Infected Patients - To evaluate the safety and tolerability of TMC435 in combination with pegylated interferon alpha-2a (PegIFNα- 2a)/ribavirin (RBV) in HCV genotype-1 infected subjects, co-infected with HIV-1. - To e...

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