CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,095 enrolled
Drug / intervention
Pegylated Interferon Alfa 2a +3 morebiological
Likely dose
Pegylated Interferon Alfa 2a 180 microgramsfrom 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/NCT00627926
NCT00627926Phase 3Completed
CompareCT.gov

A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C

Vertex Pharmaceuticals Incorporated·interventional·Posted Mar 4, 2008·Updated Aug 8, 2014

In Brief

A Phase 3 clinical trial evaluating Pegylated Interferon Alfa 2a, Telaprevir, and 2 other interventions for Hepatitis C. Completed, enrolled 1,095 participants across 116 sites in 13 countries.

Detailed Summary

A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesArgentina, Australia, Austria, Canada, France, Germany, Israel, Italy, Poland, Puerto Rico, Spain, United Kingdom, United States
CollaboratorsTibotec Pharmaceutical Limited

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 4, 2008
Enrollment StartMar 1, 2008
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 18.3 years ago

Interventions

Pegylated Interferon Alfa 2abiological

subcutaneous injection, 180 micrograms once per week

Telaprevirdrug

375 mg tablets administered orally every 8 hours at a dose of 750 mg

Ribavirindrug

200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing ≥75 kg

Placeboother

Telaprevir matching placebo