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



Status:Terminated
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:January 2012
End Date:May 2014

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An Open-Label, Phase 4 Study of Telaprevir, Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C Who Have Not Achieved a Sustained Viral Response With a Prior Course of Interferon-Based Therapy

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.

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 Black/African American (Group B). Participants did not achieve a sustained
virologic response 24 weeks after at least 1 prior course of Peg-IFN-alfa-2a/RBV therapy of
standard duration, and have 1 of the following viral responses:

- Prior relapse: Participant had a documented undetectable hepatitis C virus ribonucleic
acid (HCV RNA) level at the planned end of treatment of at least 42 weeks duration (HCV
RNA evaluated anytime between 3 weeks before and 6 weeks after the last dose of Peg
IFN-alfa-2a or RBV).

- Prior null response: Participant had a <2-log10 decrease in HCV RNA at 12 weeks, during
prior Peg IFN-alfa-2a/RBV treatment, but never achieved undetectable HCV RNA while on
treatment.

- Prior partial response: Participant had a >=2-log10 decrease in HCV RNA at 12 weeks,
during prior Peg IFN-alfa-2a/RBV treatment, but never achieved undetectable HCV RNA
while on treatment.

Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
27
sites
Baton Rouge, Louisiana
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Baton Rouge, LA
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Atlanta, Georgia
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Atlanta, GA
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Baltimore, Maryland
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Baltimore, MD
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Birmingham, Alabama
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Birmingham, AL
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Boston, Massachusetts
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Boston, MA
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Bronx, New York
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Bronx, NY
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Charlotte, North Carolina
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Charlotte, NC
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Chicago, Illinois
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Chicago, IL
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Dallas, Texas
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Dallas, TX
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Detroit, Michigan
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Detroit, MI
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Durham, North Carolina
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Durham, NC
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Houston, Texas
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Houston, TX
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Miami, Florida
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Miami, FL
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New Haven, Connecticut
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New Haven, CT
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New Orleans, Louisiana
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New Orleans, LA
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New York, New York 10001
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New York, NY
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Norfolk, Virginia
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Norfolk, VA
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Orlando, Florida
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Orlando, FL
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Philadelphia, Pennsylvania
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Philadelphia, PA
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San Antoinio, Texas
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San Antoinio, TX
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San Francisco, California
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San Francisco, CA
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Seattle, Washington
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Seattle, WA
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Shreveport, Louisiana
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Shreveport, LA
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Tampa, Florida
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Tampa, FL
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Vineland, New Jersey
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Vineland, NJ
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Washington, District of Columbia
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Washington,
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West Palm Beach, Florida
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West Palm Beach, FL
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