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
NCT ID: NCT01467492
Last Updated: 2015-08-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
121 participants
INTERVENTIONAL
2012-01-31
2014-05-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Black
Telaprevir 750 milligram (mg) tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 microgram per week (mcg/week) subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 milligram per day (mg/day) (for participants weighing \<75 kilograms \[kg\]) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
Telaprevir
Tablet
Ribavirin
Tablet
Pegylated Interferon Alfa-2a
Subcutaneous Injection
Non-Black
Telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
Telaprevir
Tablet
Ribavirin
Tablet
Pegylated Interferon Alfa-2a
Subcutaneous Injection
Interventions
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Telaprevir
Tablet
Ribavirin
Tablet
Pegylated Interferon Alfa-2a
Subcutaneous Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Vertex Pharmaceuticals Incorporated
Locations
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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
Virginia
Norfolk, Virginia, United States
Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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VX11-950-116
Identifier Type: -
Identifier Source: org_study_id
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