CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Telaprevir +3 moredrug
Likely dose
Telaprevir 750 milligramfrom 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/NCT00580801
NCT00580801Phase 2Completed
CompareCT.gov

A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 4 Hepatitis C Infection

Tibotec BVBA·interventional·Posted Dec 27, 2007·Updated Sep 9, 2013

In Brief

A Phase 2 clinical trial evaluating Telaprevir, Pegylated-interferon-alfa-2a, and 2 other interventions for Hepatitis C. Completed, enrolled 24 participants.

Detailed Summary

The purpose of this study is to evaluate the activity and safety of telaprevir on Hepatitis C Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is, pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with antiretroviral therapy) participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 27, 2007
Enrollment StartJan 1, 2008
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 18.5 years ago

Interventions

Telaprevirdrug

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

Pegylated-interferon-alfa-2adrug

Pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50.

Placebodrug

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

Ribavirindrug

Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50.