Status:
TERMINATED
Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in treatment-experienced Black/Afr...
Detailed Description
This is a single-arm, open-label, multicenter study of treatment-experienced participants with Genotype 1 CHC, who self-identified as Black/African American (Group A) or who did not self-identify as B...
Eligibility Criteria
Inclusion
- Participants self-identify as Black/African American (Group A) or did not self-identify as Black/African American (Group B)
- Participants have Genotype 1 CHC and laboratory evidence of hepatitis C virus (HCV) infection for at least 6 months
- Participants did not achieve sustained viral response 24 weeks after last dose of study drug (SVR24), after at least 1 prior course of Peg-IFN-alfa-2a/RBV therapy of standard duration
Exclusion
- Participants have received previous treatment with telaprevir or any other protease inhibitor(s) for CHC
- Participants who have evidence of hepatic decompensation
- Participants have diagnosed or suspected hepatocellular carcinoma
- Participants have any other cause of significant liver disease in addition to HCV
- Participants are currently abusing illicit drugs or alcohol, or have history of illicit substance or alcohol abuse within 2 years before the screening visit
- Participants who participated in any investigational drug study within 90 days before dosing
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01467492
Start Date
January 1 2012
End Date
May 1 2014
Last Update
August 3 2015
Active Locations (27)
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1
Alabama
Birmingham, Alabama, United States
2
California
San Francisco, California, United States
3
Connecticut
New Haven, Connecticut, United States
4
Washington, DC
Washington D.C., District of Columbia, United States