CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 744 enrolled
Drug / intervention
Ribavirin +3 moredrug
Likely dose
Ribavirin 1200 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/NCT01241760
NCT01241760Phase 3Completed
CompareCT.gov

A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

Janssen Infectious Diseases BVBA·interventional·Posted Nov 16, 2010·Updated Jun 4, 2014

In Brief

A Phase 3 clinical trial evaluating Ribavirin, Telaprevir, and 1 other intervention for Genotype 1 Chronic Hepatitis C and Treatment Naive. Completed, enrolled 744 participants across 99 sites in 13 countries.

Detailed Summary

The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGenotype 1 Chronic Hepatitis C, Treatment Naive
CountriesAustralia, Austria, Belgium, Brazil, France, Germany, Ireland, Mexico, Poland, Spain, Sweden, United Kingdom, United States
CollaboratorsVertex Pharmaceuticals Incorporated

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 16, 2010
Enrollment StartDec 1, 2010
Primary CompletionAug 1, 2012
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.6 years ago

Interventions

Ribavirindrug

Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4

Telaprevirdrug

1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks

Pegylated interferon alfa-2adrug

180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4

Telaprevirdrug

750 mg (2 oral tablets) every 8 hours for 12 weeks