NCT01080222

A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

A Randomized, Parallel-Group, Dose-Ranging Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Antiviral Activity of VX-222 and Telaprevir in Combination With and Without Peginterferon-Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or ribavirin. The subjects enrolled in this study are chronically infected with hepatitis C virus (HCV) genotype 1 and will not have previously received treatment for their HCV infection. This study will include an Investigational Phase and Extension Phase. These phases will contain a Treatment Period and a Follow-up Period. All subjects will be enrolled in the Investigational Phase of this study. Subjects who fail treatment during the Investigational Phase will have the option to enter the Extension Phase at which point they will be eligible to receive peginterferon alfa-2a and ribavirin for a total of 48 weeks. Based on an evaluation of on-treatment safety, pharmacokinetic and antiviral data from patients in each arm of the trial, Vertex may elect to enroll up to two additional treatment arms (Treatment Arm E and Treatment Arm F) that will evaluate telaprevir/VX-222-based combination therapy. The components of the treatment regimens of these arms will be selected based on clinical data that emerges from the four initially-studied regimens. If enacted, up to 25 patients are expected to enroll in each additional treatment arm. If Treatment Arm E or Treatment Arm F is discontinued subjects meeting certain criteria will have the option to enter a telaprevir-containing Rollover Phase. Subjects who do not meet the eligibility criteria to enter the Rollover Phase may elect to enter the Extension Phase.

Conditions

• Chronic Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	telaprevir	tablet, 1125-mg, twice daily
DRUG	VX-222	capsule, 100-mg, twice daily
DRUG	ribavirin	tablet, 1000-mg for subjects weighing \<75-kg or 1200-mg for subjects weighing ≥75-kg, twice daily
BIOLOGICAL	peginterferon-alfa-2a	subcutaneous injection, 180-mcg, once weekly
DRUG	VX-222	capsule, 400-mg, twice daily

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-10-01
• Completion: 2013-11-01
• First posted: 2010-03-04
• Last updated: 2020-09-30

Locations

21 sites across 2 countries: United States, New Zealand