At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 465 enrolled
Drug / intervention
Telaprevir +3 moredrug
Likely dose
Not stated in 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.
A Phase 2 Study of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral Response With a Prior Course of Interferon Based Therapy
In Brief
A Phase 2 clinical trial evaluating Telaprevir, Ribavirin, and 2 other interventions for Hepatitis C. Completed, enrolled 465 participants across 53 sites in 5 countries.
Detailed Summary
The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesCanada, Germany, Netherlands, Puerto Rico, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2007
Enrollment StartFeb 2007
Primary CompletionDec 2008
Study CompletionApr 2009
TodayJul 2026
First PostedJan 11, 2007
Enrollment StartFeb 1, 2007
Primary CompletionDec 1, 2008
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.5 years ago
Interventions
Telaprevirdrug
tablet
Ribavirindrug
tablet
Pegylated Interferon Alfa 2adrug
Solution for injection
Matching Placebodrug
Tablet