Olysio (simeprevir) News

||||||||||  Daklinza (daclatasvir) / BMS
New P2 trial, Combination therapy:  Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus (clinicaltrials.gov) -  Jun 25, 2012
P2, N=180, Active, not recruiting,  Sponsor: Bristol-Myers Squibb

||||||||||  Olysio (simeprevir) / J&J, Medivir
Trial completion:  A Study to Assess Bioavailability & Food Effect of Different Liquid and Capsule Formulations of TMC435. (clinicaltrials.gov) -  Jun 17, 2012
P1, N=72, Completed,  Sponsor: Janssen R&D Ireland
Recruiting --> Completed

||||||||||  Olysio (simeprevir) / J&J, Medivir
New P1 trial:  A Study to Assess Bioavailability & Food Effect of Different Liquid and Capsule Formulations of TMC435. (clinicaltrials.gov) -  Apr 3, 2012
P1, N=72, Completed,  Sponsor: Janssen R&D Ireland

||||||||||  Olysio (simeprevir) / J&J, Medivir
New P3 trial, Combination therapy:  RESTORE: A Study to Evaluate the Efficacy, Safety and Tolerability of TMC435 in Combination With PegIFN Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Na (clinicaltrials.gov) -  Mar 28, 2012
P3, N=107, Completed,  Sponsor: Janssen R&D Ireland

||||||||||  Olysio (simeprevir) / J&J, Medivir
Trial completion:  A Study in Healthy Female Participants Investigating the Effect of TMC435 on the Pharmacokinetics of the Synthetic Hormones of the Oral Contraceptive Ovysmen (clinicaltrials.gov) -  Feb 13, 2012
P1, N=18, Completed,  Sponsor: Tibotec Pharmaceuticals, Ireland
Recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Olysio (simeprevir) / J&J, Medivir
Trial completion:  TMC435-TiDP16-C126 - Trial to Investigate the Effect of Severe Renal Impairment on the Pharmacokinetics and Safety of TMC435 (clinicaltrials.gov) -  Jan 29, 2012
P1, N=16, Completed,  Sponsor: Tibotec Pharmaceuticals, Ireland
Active, not recruiting --> Completed Recruiting --> Completed

||||||||||  Olysio (simeprevir) / J&J, Medivir
Trial completion:  A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and Tacrolimus (clinicaltrials.gov) -  Jan 9, 2012
P1, N=29, Completed,  Sponsor: Tibotec Pharmaceuticals, Ireland
Recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Olysio (simeprevir) / J&J, Medivir
Trial completion:  ASPIRE: A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment (clinicaltrials.gov) -  Jan 9, 2012
P2b, N=464, Completed,  Sponsor: Tibotec Pharmaceuticals, Ireland
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  TMC647055 / J&J, Olysio (simeprevir) / J&J, Medivir
Trial completion, Combination therapy:  TMC647055HPC1001 - First-in-human Trial to Examine Safety, Tolerability and Pharmacokinetics (How the Drug is Absorbed Into the Bloodstream) of Increasing Single Oral Doses and of Increasing Repeated Oral Doses of TMC647055 in Healthy Volunteers and in Hepatitis C Virus Infected Patients (clinicaltrials.gov) -  Dec 14, 2011
P1, N=72, Completed,  Sponsor: Tibotec Pharmaceuticals, Ireland
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Olysio (simeprevir) / J&J, Medivir
Trial completion:  TMC435-TiDP16-C117: The Effect of TMC435 on the Results of Electrocardiograms (Electric Recording of the Heart) in Healthy Volunteers (clinicaltrials.gov) -  Dec 6, 2011
P1, N=60, Completed,  Sponsor: Tibotec Pharmaceuticals, Ireland
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Olysio (simeprevir) / J&J, Medivir, Incivek (telaprevir) / J&J, Vertex, Mitsubishi Tanabe
New P3 trial, Combination therapy:  TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINF?-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINF?-2a and Ribavirin Therapy (clinicaltrials.gov) -  Dec 4, 2011
P3, N=766, Active, not recruiting,  Sponsor: Janssen R&D Ireland

||||||||||  Olysio (simeprevir) / J&J, Medivir
New P1 trial:  A Study in Healthy Female Participants Investigating the Effect of TMC435 on the Pharmacokinetics of the Synthetic Hormones of the Oral Contraceptive Ovysmen (clinicaltrials.gov) -  Dec 4, 2011
P1, N=18, Completed,  Sponsor: Tibotec Pharmaceuticals, Ireland

||||||||||  Olysio (simeprevir) / J&J, Medivir
New P1 trial:  A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and Tacrolimus (clinicaltrials.gov) -  Nov 24, 2011
P1, N=29, Completed,  Sponsor: Tibotec Pharmaceuticals, Ireland

||||||||||  Edurant (rilpivirine) / J&J, Olysio (simeprevir) / J&J, Medivir
Trial completion:  TMC435-TiDP16-C114 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents TMC278 and Tenofovir (clinicaltrials.gov) -  Nov 22, 2011
P1, N=48, Completed,  Sponsor: Tibotec Pharmaceuticals, Ireland
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Olysio (simeprevir) / J&J, Medivir
Trial completion:  TMC435-TiDP16-C115 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Erythromycin and Between TMC435 and Darunavir/Ritonavir (DRV/r) (clinicaltrials.gov) -  Oct 30, 2011
P1, N=49, Completed,  Sponsor: Tibotec Pharmaceuticals, Ireland
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Olysio (simeprevir) / J&J, Medivir
Trial completion:  TMC435-TiDP16-C113: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of TMC435 (clinicaltrials.gov) -  Sep 8, 2011
P1, N=23, Completed,  Sponsor: Tibotec Pharmaceuticals, Ireland
Active, not recruiting --> Completed Recruiting --> Completed



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