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

PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

December 12, 2013

Primary Completion Date

April 27, 2015

Study Completion Date

July 28, 2015

Conditions
Hepatitis C, Chronic
Interventions
DRUG

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.

DRUG

Daclatasvir

Participants will receive 60 milligram tablet of daclatasvir orally once daily for 24 weeks.

DRUG

Ribavirin

Participants will receive 5 or 6 tablets of 200 milligram of ribavirin orally twice a day with food for 24 weeks.

DRUG

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.

DRUG

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.

Trial Locations (6)

Unknown

Essen

Hamburg

Warsaw

Barcelona

Madrid

Valencia

All Listed Sponsors
lead

Janssen R&D Ireland

INDUSTRY

NCT01938625 - 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 | Biotech Hunter | Biotech Hunter