VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C
NCT ID: NCT01581138
Last Updated: 2014-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2012-07-31
2013-12-31
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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12 week treatment
VX-222
400 mg tablets twice daily for oral administration
telaprevir
1125 mg tablets twice daily for oral administration
ribavirin
1000 mg per day for subjects weighing \<75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily
16 week treatment
VX-222
400 mg tablets twice daily for oral administration
telaprevir
1125 mg tablets twice daily for oral administration
ribavirin
1000 mg per day for subjects weighing \<75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily
Interventions
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VX-222
400 mg tablets twice daily for oral administration
telaprevir
1125 mg tablets twice daily for oral administration
ribavirin
1000 mg per day for subjects weighing \<75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects will be treatment naïve
* Subjects must have documentation of the presence or absence of cirrhosis
Exclusion Criteria
* Evidence of hepatic decompensation
* Diagnosed or suspected hepatocellular carcinoma
* 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
* History of organ transplant, with the exception of corneal transplants and skin grafts
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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Birmingham, Alabama, United States
Anaheim, California, United States
Riverside, California, United States
San Diego, California, United States
Englewood, Colorado, United States
Orlando, Florida, United States
Marietta, Georgia, United States
Baltimore, Maryland, United States
New York, New York, United States
Asheville, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Pittsburgh, Pennsylvania, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Countries
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Other Identifiers
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VX11-222-108
Identifier Type: -
Identifier Source: org_study_id
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