Status:
COMPLETED
A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment
Lead Sponsor:
Tibotec BVBA
Collaborating Sponsors:
Tibotec Pharmaceutical Limited
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatm...
Detailed Description
This is a randomized, double-blind, placebo-controlled Phase III trial with telaprevir in patients with chronic Hepatitis C Virus (HCV), genotype 1, infection who failed prior treatment with standard ...
Eligibility Criteria
Inclusion
- Patient must have chronic hepatitis C infection (genotype 1) with HCV RNA level \>= 1000 IU/mL
- Patient must have failed at least 1 prior course of Peg-IFN/RBV therapy (standard treatment)
- Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication
Exclusion
- Patient is a previous non-responder that is classified as a viral breakthrough case
- Patient is infected with Hepatitis C virus, genotype 1, exhibiting more than one subtype
- Patient has Hepatitis C virus, genotype 1, and exhibits co-infection with any other genotype
- Evidence of decompensated liver disease
- Patient has condition that requires use of systemic corticosteroids
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
663 Patients enrolled
Trial Details
Trial ID
NCT00703118
Start Date
October 1 2008
End Date
July 1 2010
Last Update
January 22 2014
Active Locations (91)
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1
Birmingham, Alabama, United States
2
Coronado, California, United States
3
La Jolla, California, United States
4
Los Angeles, California, United States