NCT01459913

Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype

A Phase 3b Study of 2 Treatment Durations of Telaprevir, Peg-IFN (Pegasys®), and Ribavirin (Copegus®) in Treatment-Naive and Prior Relapser Subjects With Genotype 1 Chronic Hepatitis C and IL28B CC Genotype

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Telaprevir	Tablet
DRUG	Pegylated Interferon Alfa-2a	Subcutaneous Injection
DRUG	Ribavirin	Tablet

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2011-10-26
• Last updated: 2015-06-10
• Results posted: 2015-02-11

Locations

83 sites across 6 countries: United States, Austria, Canada, Germany, Israel, Poland