A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis
NCT ID: NCT01516918
Last Updated: 2014-10-20
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
103 participants
INTERVENTIONAL
2012-02-29
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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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Quadruple Regimen
All subjects will receive active study drugs (quadruple regimen: VX-222, telaprevir,Peg-IFN, and RBV) for a fixed treatment duration of 24 weeks.
VX-222
tablet, 400-mg twice daily
telaprevir
tablet, 1125-mg twice daily
ribavirin
tablet, 1000-mg per day for subjects weighing \<75 kg and 1200 mg per day for subjects weighing ≥75 kg, twice daily
peginterferon-alfa-2a
subcutaneous injection, 180-mcg, once weekly
Interventions
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VX-222
tablet, 400-mg twice daily
telaprevir
tablet, 1125-mg twice daily
ribavirin
tablet, 1000-mg per day for subjects weighing \<75 kg and 1200 mg per day for subjects weighing ≥75 kg, twice daily
peginterferon-alfa-2a
subcutaneous injection, 180-mcg, once weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must have compensated cirrhosis
* Subjects may either be treatment naïve, or may have received a course of Peg IFN/RBV without evidence of response. Subjects who are considered to be relapsers to Peg IFN/RBV, or who are partial or null responders will be considered
* Subjects with hemophilia may be permitted to enroll with permission of the medical monitor
Exclusion Criteria
* Any contraindication to Peg-IFN or RBV therapy
* Evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices
* A history of acquired immunodeficiency infection, organ transplantation or have an ongoing requirement for immunosuppressive medicines
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
San Diego, California, United States
Englewood, Colorado, United States
Bradenton, Florida, United States
Jacksonville, Florida, United States
Tampa, Florida, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Lebanon, New Hampshire, United States
Egg Harbor, New Jersey, United States
Manhasset, New York, United States
New York, New York, United States
Rochester, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Providence, Rhode Island, United States
Germantown, Tennessee, United States
Arlington, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Vancouver, British Columbia, Canada
London, Ontario, Canada
Montreal, Quebec, Canada
Cologne, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Hessen, , Germany
Saschen, , Germany
Stuttgart, , Germany
Bialystok, , Poland
Mysłowice, , Poland
Wroclaw, , Poland
London, , United Kingdom
Plymouth, , United Kingdom
Scotland, , United Kingdom
Countries
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Other Identifiers
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VX11-222-106
Identifier Type: -
Identifier Source: org_study_id
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