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 |
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.
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.
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
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