NCT01581138

VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C

A Multicenter, Randomized, Open-label, Phase 2b Study to Evaluate the Efficacy and Safety of Two Regimens of All-oral Triple Therapy (VX-222 in Combination With Telaprevir [Incivek™] and Ribavirin [Copegus®]) in Treatment-Naïve Subjects With Genotype 1a Chronic Hepatitis C

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (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 efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.

Conditions

• Chronic Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	VX-222	400 mg tablets twice daily for oral administration
DRUG	telaprevir	1125 mg tablets twice daily for oral administration
DRUG	ribavirin	1000 mg per day for subjects weighing \<75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-06-01
• Completion: 2013-12-01
• First posted: 2012-04-20
• Last updated: 2014-07-04

Locations

18 sites across 1 country: United States