CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 663 enrolled
Drug / intervention
Telaprevir +3 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/NCT00703118
NCT00703118Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic, Genotype 1, Hepatitis C Infection Who Failed Prior Standard Treatment

Tibotec BVBA·interventional·Posted Jun 23, 2008·Updated Jan 22, 2014

In Brief

A Phase 3 clinical trial evaluating Telaprevir, Peg-IFN-alfa-2a, and 2 other interventions for Hepatitis C, Chronic. Completed, enrolled 663 participants across 91 sites in 16 countries.

Detailed Summary

The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 23, 2008
Enrollment StartOct 1, 2008
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.0 years ago

Interventions

Telaprevirdrug

Participants will receive telaprevir tablets of 750 mg orally eight hourly for 12 weeks in group A and B.

Peg-IFN-alfa-2adrug

Participants will receive 180 µg subcutaneous (under the skin) injection of Peg-IFN-alfa-2a once weekly for 48 weeks in Group A, B and C.

Ribavirindrug

Participants will receive ribavirin tablets of 1000-1200 mg orally twice daily for 48 weeks in Group A, B, and C.

Placebodrug

Participants will receive telaprevir matching placebo tablets orally for 4 weeks in Group A and B. Participants will receive telaprevir matching placebo tablets orally for 16 weeks in Group C.