Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype
NCT ID: NCT01459913
Last Updated: 2015-06-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
239 participants
INTERVENTIONAL
2011-11-30
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus \[HCV\] Ribonucleic Acid \[RNA\] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment.
Telaprevir
Tablet
Pegylated Interferon Alfa-2a
Subcutaneous Injection
Ribavirin
Tablet
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
Telaprevir 1125 mg tablet twice daily 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 subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
Telaprevir
Tablet
Pegylated Interferon Alfa-2a
Subcutaneous Injection
Ribavirin
Tablet
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily 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 subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
Telaprevir
Tablet
Pegylated Interferon Alfa-2a
Subcutaneous Injection
Ribavirin
Tablet
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Telaprevir 1125 mg tablet twice daily 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 subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
Telaprevir
Tablet
Pegylated Interferon Alfa-2a
Subcutaneous Injection
Ribavirin
Tablet
Interventions
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Telaprevir
Tablet
Pegylated Interferon Alfa-2a
Subcutaneous Injection
Ribavirin
Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment-naive OR subjects (prior relapsers) may be included who did not achieve sustained viral response 24 weeks after last planned dose of study drug (SVR24) after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and had a documented undetectable HCV RNA level at the planned end of treatment of at least 42-week duration
* Subjects have IL28B CC genotype determined during screening
* Subjects have genotype 1 chronic hepatitis C and laboratory evidence of HCV infection for at least 6 months, defined by (1) documented HCV serology test at least 6 months before the first screening visit demonstrating the presence of anti-HCV antibody, or (2) documented presence of HCV RNA by a sensitive and specific assay at least 6 months before the first screening visit, or (3) documented histologic evidence of chronic hepatitis C demonstrated by fibrosis on a standardized histologic grading system at least 6 months before the first screening visit. If only inflammation is present in the liver histologic report, then 6 months of laboratory evidence is required
Exclusion Criteria
* Subjects who did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and never achieved undetectable HCV RNA while on treatment
* Subjects have evidence of hepatic decompensation
* Subjects have evidence of cirrhosis
* Subjects have diagnosed or suspected hepatocellular carcinoma
* Subjects have any other cause of significant liver disease in addition to hepatitis C, which may include but is not limited to malignancy with hepatic involvement, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis. Steatosis is allowed if clinically asymptomatic
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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Mark Friedman, M.D.
Role: STUDY_DIRECTOR
Vertex Pharmaceuticals Incorporated
Locations
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New Haven, Connecticut, United States
Bradenton, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Phoenix, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
California
Los Angeles, California, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
California
San Francisco, California, United States
Farmington, Connecticut, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Columbia, Maryland, United States
Boston, Massachusetts, United States
Brockton, Massachusetts, United States
Burlington, Massachusetts, United States
Worcester, Massachusetts, United States
Novi, Michigan, United States
Kansas City, Missouri, United States
Lebanon, New Hampshire, United States
Egg Harbor, New Jersey, United States
Vineland, New Jersey, United States
Flushing, New York, United States
Manhasset, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Pennsylvania
Hershey, Pennsylvania, United States
Arlington, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Virginia
Fairfax, Virginia, United States
Falls Church, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Linz, , Austria
Vienna, , Austria
Vienna, , Austria
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Berlin, , Germany
Cologne, , Germany
Düsseldorf, , Germany
Frankfurt, , Germany
Hamburg, , Germany
Hanover, , Germany
Leipzig, , Germany
Munich, , Germany
Haifa, , Israel
Haifa, , Israel
Israel
Jerusalem, , Israel
Nazareth, , Israel
Petah Tikva, , Israel
Tel Litwinsky, , Israel
Bialystok, , Poland
Czeladź, , Poland
Mysłowice, , Poland
Wroclaw, , Poland
Countries
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Other Identifiers
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VX11-950-114
Identifier Type: -
Identifier Source: org_study_id
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