NCT01516918

A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis

A Multicenter, Open-Label Phase 2b Pilot Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2, and Ribavirin) in Subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (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 the safety and efficacy of a quadruple regimen (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with cirrhosis.

Conditions

• Chronic Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	VX-222	tablet, 400-mg twice daily
DRUG	telaprevir	tablet, 1125-mg twice daily
DRUG	ribavirin	tablet, 1000-mg per day for subjects weighing \<75 kg and 1200 mg per day for subjects weighing ≥75 kg, twice daily
BIOLOGICAL	peginterferon-alfa-2a	subcutaneous injection, 180-mcg, once weekly

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-09-01
• Completion: 2013-12-01
• First posted: 2012-01-25
• Last updated: 2014-10-20

Locations

43 sites across 5 countries: United States, Canada, Germany, Poland, United Kingdom