A Study to Examine Patient Characteristics, Health Care Management and Health Outcomes of Hepatitis C Virus (HCV) Patients Treated With Simeprevir
NCT ID: NCT02103699
Last Updated: 2016-02-22
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
315 participants
OBSERVATIONAL
2014-02-28
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hepatitis C virus infected patients receiving simeprevir
No intervention
This is an observational study. Patients receiving simeprevir (single capsule of 150 mg once daily) as prescribed by the health care provider will be observed.
Interventions
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No intervention
This is an observational study. Patients receiving simeprevir (single capsule of 150 mg once daily) as prescribed by the health care provider will be observed.
Eligibility Criteria
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Inclusion Criteria
* Hepatitis C virus (HCV) ribonucleic acid (RNA) test result above the limit of quantification before initiation of simeprevir-based therapy
* Health care provider decision to treat patient with a simeprevir-based therapy, inclusive of patients who have been treated with a simeprevir-based therapy for less than or equal to (\<=) 28 days will be enrolled into the study
* Prior HCV treatment must be completed more than 3 months before initiation of simeprevir-based therapy
* In the opinion of the health care provider, the patient will attend routine standard of care visits, either at enrolled site or by virtual/telemedicine
Exclusion Criteria
* Absolute contraindication to any component of prescribed HCV treatment per prescribing information
* Patient is currently enrolled in an interventional study
* Past use of an HCV direct-acting antiviral therapy
* Any investigational drug use within 30 days before initiation of simeprevir-based therapy
18 Years
ALL
No
Sponsors
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Janssen Scientific Affairs, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Scientific Affairs, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Scientific Affairs, LLC
Locations
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Phoenix, Arizona, United States
Bakersfield, California, United States
Beverly Hills, California, United States
Los Angeles, California, United States
Daytona Beach, Florida, United States
DeLand, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Crestview Hills, Kentucky, United States
Baltimore, Maryland, United States
Springfield, Massachusetts, United States
Newark, New Jersey, United States
Vineland, New Jersey, United States
Brooklyn, New York, United States
Flushing, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Fayetteville, North Carolina, United States
Rocky Mount, North Carolina, United States
Statesville, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Doylestown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Murray, Utah, United States
Norfolk, Virginia, United States
Countries
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Other Identifiers
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TMC435HPC4003
Identifier Type: OTHER
Identifier Source: secondary_id
CR101973
Identifier Type: -
Identifier Source: org_study_id
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