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 Transpl

• Status: Completed
• Trial end date: 2015-07-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate effect of steady-state (when the amount of drug administered (in a given time period is equal to the amount of drug eliminated in that same period) of simeprevir and daclatasvir on the steady-state pharmacokinetics (what a medication does to the body) of cyclosporine (applicable to Part 1 only) and tacrolimus when administered as a combinational regimen in post-orthotopic liver transplantation (OLT) participants with recurrent hepatitis C virus (HCV) genotype 1b infection and effectiveness of a 24-week treatment regimen containing simeprevir, daclatasvir, and ribavirin (RBV) with respect to the proportion of HCV genotype 1b infected post-OLT participants achieving sustained virologic response 12 weeks after end of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen R&D Ireland
• Treatments: Cyclosporine; Cyclosporins; Immunosuppressive Agents; Ribavirin; Simeprevir; Tacrolimus

Criteria

Inclusion Criteria:

• Liver transplant between 6 months and 10 years prior to the screening visit

• Hepatitis C virus (HCV) genotype 1 subtype b infection confirmed at screening

• Screening HCV ribonucleic acid level greater than 10,000 IU/mL

• HCV treatment-naïve participants must not have received post orthotopic liver transplant treatment with any approved or investigational drug for the treatment of HCV

• Receiving stable immunosuppressant therapy (ie, no change in dose in the last month) with cyclosporine (only allowed in Part 1) or tacrolimus for more than 3 months prior to the screening visit

Exclusion Criteria:

• Evidence of acute or chronic hepatic decompensation after the liver transplantation (including ascites, bleeding varices or hepatic encephalopathy)

• Any liver disease of non-HCV etiology, including current evidence of graft rejection except the presence of liver steatosis

• Any other clinically significant disease that in the opinion of the investigator would be exacerbated by the known effects of ribavirin

• Coinfection with HCV of another genotype than genotype 1b, HIV type 1 or 2 (positive HIV-1 or HIV-2 antibodies test at screening), and hepatitis B virus (hepatitis B surface antigen positive)

• Multi-organ transplant that included heart, lung, pancreas, or kidney