NCT01467505

An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients

A 2-Part, Open Label Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Chronically Infected With Genotype 1 Hepatitis C Virus Following Liver Transplantation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To assess efficacy of telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) for hepatitis C virus (HCV) in a 48-week total treatment duration regimen following liver transplantation.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Telaprevir	Tablet
DRUG	Ribavirin	Tablet
DRUG	Pegylated Interferon Alfa-2a	Subcutaneous Injection
DRUG	Immunosuppressant Regimen	Cyclosporine (CsA) based immunosuppressant regimen or Tacrolimus (TAC) based immunosuppressant regimen, as per standard practice. Immunosuppressant regimen were not considered study drugs.

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2011-11-08
• Last updated: 2015-06-18
• Results posted: 2015-06-18

Locations

22 sites across 2 countries: United States, Canada