VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naive Patients With Genotype 1 Chronic Hepatitis C Virus Infection.
Status: | Archived |
---|---|
Conditions: | Infectious Disease, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
Start Date: | February 2010 |
End Date: | October 2012 |
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-naive Subjects With Genotype 1 Chronic Hepatitis C Virus Infection.
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-naÃ-ve patients with chronic HCV genotype 1 infection.
This is a randomised (study drug assigned by chance), open-label (all persons know the study
drug assignment) multicenter study to evaluate the effectiveness of telaprevir administered
orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with
Peg-IFN-alfa-2a, administered via intramuscular injection once a week, and ribavirin,
administered as an oral tablet twice a day, in treatment-naïve patients with chronic HCV
genotype 1 infection. Telaprevir will be given orally (by mouth) from Day 1 through Week 12
as 3 tablets (1125mg) twice daily or 2 tablets (750mg) every 8 hours. Peg-IFN-alfa-2a will
be administered once a week as an injection under the skin (180 microgram/week) from Day 1
through Week 24 or 48 (based on the patient's treatment response on week 4). Ribavirin is
administered orally (by mouth) twice daily from Day 1 through Week 24 or 48 (based on the
patient's treatment response on week 4) as 1,000-1,200mg per day.
We found this trial at
24
sites
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