CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 166 enrolled
Drug / intervention
Telaprevir +4 moredrug
Likely dose
Telaprevir 375 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/NCT00528528
NCT00528528Phase 2Completed
CompareCT.gov

A Phase IIa Randomized, Open-Label Study of Telaprevir (VX-950) Administered Every 12 or Every 8 Hours in Combination With Either Peg-IFN alfa2a (Pegasys) and Ribavirin (Copegus) or Peg-IFN alfa2b (PegIntron) and Ribavirin (Rebetol) in Treatment-Naive Subjects With Chronic Genotype 1 Hepatitis C Infection

Tibotec BVBA·interventional·Posted Sep 12, 2007·Updated Jun 25, 2014

In Brief

A Phase 2 clinical trial evaluating Telaprevir, Peg-IFN-alfa-2a, and 3 other interventions for Chronic Hepatitis C. Completed, enrolled 166 participants across 24 sites in 6 countries.

Detailed Summary

The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
CountriesAustria, Belgium, France, Germany, Netherlands, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2007
Enrollment StartOct 1, 2007
Primary CompletionJul 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.8 years ago

Interventions

Telaprevirdrug

Oval tablets containing 375 mg of telaprevir for oral administration.

Peg-IFN-alfa-2adrug

Solution containing Peg-IFN alfa2a for subcutaneous injection in a pre-filled syringe.

Peg-IFN-alfa-2bdrug

Powder containing Peg-IFN-alfa-2b and solvent for solution for subcutaneous injection in a pre-filled pen.

Ribavirin (RBV) tabletdrug

Tablets containing 200 mg RBV for oral administration.

Ribavirin (RBV) capsuledrug

Capsules containing 200 mg RBV for oral administration.