Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis
NCT ID: NCT02114151
Last Updated: 2016-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
103 participants
INTERVENTIONAL
2014-04-30
2015-04-30
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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Arm 1 (Simeprevir/Sofosbuvir)
100 participants will receive 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
Simeprevir
100 participants will receive 1 capsule of 150 mg orally once daily for 12 weeks.
Sofosbuvir
100 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks.
Interventions
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Simeprevir
100 participants will receive 1 capsule of 150 mg orally once daily for 12 weeks.
Sofosbuvir
100 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* HCV ribonucleic acid (RNA) greater than 10,000 IU/mL at screening
* Treatment-experienced participants must have at least 1 documented previous course of interferon-based regimen with or without ribavirin
* Participants must have an hepatic imaging procedure (ultrasound, computerized tomography scan or magnetic resonance imaging scan) within 6 months prior to the screening visit (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma
* Participant must be willing and able to comply with the protocol requirements
* Participants with liver cirrhosis
Exclusion Criteria
* Infection/co-infection with HCV non-genotype 1
* Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening)
* Co-infection with hepatitis B virus (hepatitis B-surface-antigen positive)
* Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection
18 Years
70 Years
ALL
No
Sponsors
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Janssen Infectious Diseases BVBA
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Infectious Diseases BVBA Clinical Trial
Role: STUDY_DIRECTOR
Janssen Infectious Diseases BVBA
Locations
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Dothan, Alabama, United States
Bakersfield, California, United States
Chula Vista, California, United States
Los Angeles, California, United States
San Diego, California, United States
Englewood, Colorado, United States
Bradenton, Florida, United States
Lauderdale Lakes, Florida, United States
Maitland, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Wellington, Florida, United States
Atlanta, Georgia, United States
Columbus, Georgia, United States
Marietta, Georgia, United States
Jackson, Mississippi, United States
Kansas City, Missouri, United States
Hillsborough, New Jersey, United States
Vineland, New Jersey, United States
New York, New York, United States
Asheville, North Carolina, United States
Winston-Salem, North Carolina, United States
East Greenwich, Rhode Island, United States
Providence, Rhode Island, United States
Greer, South Carolina, United States
Germantown, Tennessee, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Austin, Texas, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Vancouver, British Columbia, Canada
Montreal, Quebec, Canada
Countries
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Other Identifiers
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TMC435HPC3018
Identifier Type: OTHER
Identifier Source: secondary_id
CR103431
Identifier Type: -
Identifier Source: org_study_id
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