NCT00758043

A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response

A Randomized Study of Stopping Treatment at 24 Weeks or Continuing Treatment to 48 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response While Receiving Telaprevir, Peginterferon Alfa2a (Pegasys®) and Ribavirin (Copegus®)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	telaprevir	750 mg every 8 hours (q8h) for 12 weeks
DRUG	ribavirin	1000 - 1200 mg/day based on body weight for either 24 or 48 weeks
BIOLOGICAL	peginterferon alfa-2a	180 mcg/week for either 24 or 48 weeks

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-06-01
• Completion: 2010-07-01
• First posted: 2008-09-23
• Last updated: 2021-03-26
• Results posted: 2011-07-21

Locations

82 sites across 4 countries: United States, Belgium, Netherlands, Puerto Rico