CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 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/NCT00561015
NCT00561015Phase 2Completed
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A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection

Tibotec BVBA·interventional·Posted Nov 20, 2007·Updated Jun 17, 2013

In Brief

A Phase 2 clinical trial evaluating Telaprevir, Peg-IFN-alfa-2a + Ribavirin (Standard Treatment), and 1 other intervention for Hepatitis C, Chronic. Completed, enrolled 52 participants across 7 sites in 3 countries.

Detailed Summary

The purpose of this study is to assess the effect of telaprevir on early hepatitis (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who are chronically (lasting a long time) infected with genotype 2 or 3 HCV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesFrance, Sweden, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 20, 2007
Enrollment StartDec 1, 2007
Primary CompletionJun 1, 2008
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.6 years ago

Interventions

Telaprevirdrug

Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.

Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)drug

Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 \& PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.

Placebodrug

Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks.