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

Stopped early · Phase 4

Conditions studied: Hepatitis C

In brief

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/African American and non-Black/African American participants with Genotype 1 Chronic Hepatitis C (CHC), who have not achieved a sustained viral response with a prior course of interferon-based therapy.

Key facts

Study ID

NCT01467492

Run by

Vertex Pharmaceuticals Incorporated

People needed

121

Starts

2012-01-01

Expected to finish

2014-05-01

Last updated by the study team

2015-08-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alabama — Birmingham, Alabama, United States
• California — San Francisco, California, United States
• Connecticut — New Haven, Connecticut, United States
• Washington, DC — Washington D.C., District of Columbia, United States
• Florida — Miami, Florida, United States
• Florida — Orlando, Florida, United States
• Florida — Tampa, Florida, United States
• Florida — West Palm Beach, Florida, United States
• Georgia — Atlanta, Georgia, United States
• Illinois — Chicago, Illinois, United States
• Louisiana — Baton Rouge, Louisiana, United States
• Louisiana — New Orleans, Louisiana, United States
• Louisiana — Shreveport, Louisiana, United States
• Maryland — Baltimore, Maryland, United States
• Massachusetts — Boston, Massachusetts, United States
• Michigan — Detroit, Michigan, United States
• New Jersey — Vineland, New Jersey, United States
• New York — New York, New York, United States
• New York — The Bronx, New York, United States
• North Carolina — Charlotte, North Carolina, United States
• North Carolina — Durham, North Carolina, United States
• Pennsylvania — Philadelphia, Pennsylvania, United States
• Texas — Dallas, Texas, United States
• Texas — Houston, Texas, United States
• Texas — San Antoinio, Texas, United States

Full record on ClinicalTrials.gov

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