CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 540 enrolled
Drug / intervention
telaprevir +2 moredrug
Likely dose
telaprevir 750 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00758043
NCT00758043Phase 3Completed
CompareCT.gov

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®)

Vertex Pharmaceuticals Incorporated·interventional·Posted Sep 23, 2008·Updated Mar 26, 2021

In Brief

A Phase 3 clinical trial evaluating telaprevir, ribavirin, and 1 other intervention for Hepatitis C. Completed, enrolled 540 participants across 82 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesBelgium, Netherlands, Puerto Rico, United States
CollaboratorsTibotec Pharmaceutical Limited

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 23, 2008
Enrollment StartOct 1, 2008
Primary CompletionJun 1, 2010
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.8 years ago

Interventions

telaprevirdrug

750 mg every 8 hours (q8h) for 12 weeks

ribavirindrug

1000 - 1200 mg/day based on body weight for either 24 or 48 weeks

peginterferon alfa-2abiological

180 mcg/week for either 24 or 48 weeks