At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 117 enrolled
Drug / intervention
Telaprevir +2 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 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response
In Brief
A Phase 2 clinical trial evaluating Telaprevir, Ribavirin, and 1 other intervention for Hepatitis C. Completed, enrolled 117 participants across 62 sites in 8 countries.
Detailed Summary
To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesAustria, Canada, France, Germany, Netherlands, Puerto Rico, United Kingdom, United States
CollaboratorsTibotec, Inc
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2007
Enrollment StartOct 2007
Primary CompletionFeb 2010
TodayJul 2026
First PostedSep 26, 2007
Enrollment StartOct 1, 2007
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.8 years ago
Interventions
Telaprevirdrug
Tablet
Ribavirindrug
Tablet
Pegylated interferon alfa 2adrug
Solution for Injection