Genotype 1 Chronic Hepatitis C Clinical Trial
Official title:
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
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.
This is a randomized (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 study participants with
chronic hepatitis C virus (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 participant's treatment
response on week 4) as 1,000-1,200 mg per day. After the end of treatment (Week 24, Week 48,
or at early discontinuation of all study drugs), participants with undetectable HCV RNA at
end of treatment will be required to attend follow-up visits until Week 72
safety/tolerability assessments will be performed throughout the treatment period and during
the follow-up period.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01498068 -
Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C
|
Phase 3 | |
| Completed |
NCT00606086 -
Safety and Efficacy of the Therapeutic Vaccine GI-5005 Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of Care Alone in Patients With Genotype 1 Chronic Hepatitis C Infection
|
Phase 2 |