CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 90 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/NCT01054573
NCT01054573Phase 3Completed
CompareCT.gov

An Open-label, Single-arm, Roll-over Trial of Telaprevir in Combination With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) for Subjects From the Control Group of the VX- 950-TiDP24-C216 Trial Who Failed Therapy for Virologic Reasons

Janssen Infectious Diseases BVBA·interventional·Posted Jan 22, 2010·Updated May 8, 2013

In Brief

A Phase 3 clinical trial evaluating Telaprevir, pegylated interferon (Peg-IFN) alfa-2a, and 1 other intervention for Hepatitis C, Chronic. Completed, enrolled 90 participants across 48 sites in 15 countries.

Detailed Summary

The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesAustralia, Belgium, Brazil, Canada, France, Germany, Israel, Netherlands, Poland, Puerto Rico, Spain, Sweden, Switzerland, United Kingdom, United States
CollaboratorsVertex Pharmaceuticals Incorporated

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 22, 2010
Enrollment StartApr 1, 2010
Primary CompletionMar 1, 2012
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 16.4 years ago

Interventions

Telaprevirdrug

750 mg orally every 8 hours (q8h) for 12 weeks

pegylated interferon (Peg-IFN) alfa-2adrug

180 microgram (mcg) by subcutaneous injection once weekly for 48 weeks.

ribavirin (RBV)drug

1,000 or 1,200 mg/day (weight based) orally twice daily for 48 weeks.