35
Participants
Start Date
December 12, 2013
Primary Completion Date
April 27, 2015
Study Completion Date
July 28, 2015
Simeprevir
Participants will receive 150 milligram capsule of simeprevir orally (by mouth) once daily with food for 24 weeks. In Part 1, if simeprevir pre-dose plasma concentration is greater than 7,300 nanogram per milliliter (ng/mL), participants will receive simeprevir 150 milligram capsule orally every other day to complete 24 weeks of treatment.
Daclatasvir
Participants will receive 60 milligram tablet of daclatasvir orally once daily for 24 weeks.
Ribavirin
Participants will receive 5 or 6 tablets of 200 milligram of ribavirin orally twice a day with food for 24 weeks.
Cyclosporine
Participants will receive cyclosporine as one of the stable immunosuppressant therapy (no change in dose in the last month) for more than 3 months prior to the screening visit. Cyclosporine will be administered as per the manufacturer's prescribing information for 24 weeks.
Tacrolimus
Participants will receive tacrolimus as one of the stable immunosuppressant therapy (no change in dose in the last month) for more than 3 months prior to the screening visit. Tacrolimus will be administered as per the manufacturer's prescribing information for 24 weeks.
Essen
Hamburg
Warsaw
Barcelona
Madrid
Valencia
Janssen R&D Ireland
INDUSTRY