A Study to Examine Patient Characteristics, Health Care Management and Health Outcomes of Hepatitis C Virus (HCV) Patients Treated With Simeprevir



Status:Completed
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2014
End Date:January 2016

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A Prospective Observational Study to Examine Patient Characteristics, Health Care Management, and Effectiveness Among HCV Patients Treated With Simeprevir at Various Practice Settings

The purpose of this study is to evaluate the effectiveness of a simeprevir-containing
hepatitis C virus (HCV) treatment regimen as measured by sustained virologic response (SVR).

This is a multicenter, observational (a study in which the investigators/ physicians observe
the patients and measure their outcomes), prospective study (a study in which the patients
are identified and then followed forward in time for the outcome of the study) designed to
reflect routine clinical practice. Approximately 300 Hepatitis C virus (HCV) infected
patients who are prescribed simeprevir by their health care provider as part of their
routine HCV treatment regimen, inclusive of patients who have been treated with a
simeprevir-based therapy for less than or equal to (<=) 28 days will be enrolled in this and
observed to evaluate the effectiveness of a simeprevir. Practice setting features will be
documented at the initiation of the study by each participating site. The decision of
patients to participate in this study will in no way impact upon the standard of care that
they are receiving. All treatment decisions will be made at the discretion of the health
care provider. Safety assessments will include assessment of adverse events, and clinical
laboratory parameters (hematology, clotting tests, human immunodeficiency virus tests,
chemistry, and liver function tests). The maximum study duration for each patient will be
approximately 2 years.

Inclusion Criteria:

- Patients who have genotype 1 chronic hepatitis C infection

- 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:

- Non-genotype 1 HCV infected patients

- 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
We found this trial at
39
sites
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Flushing, NY
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Austin, TX
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Bakersfield, CA
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Baltimore, MD
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Baltimore, MD
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Beverly Hills, California 90211
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Brooklyn, NY
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Cincinnati, OH
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Crestview Hills, Kentucky 41017
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Crestview Hills, KY
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Dallas, TX
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Daytona Beach, FL
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DeLand, FL
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Doylestown, PA
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Durham, NC
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Fayetteville, North Carolina 28304
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Fayetteville, NC
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Fort Worth, TX
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Houston, TX
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Houston, TX
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Los Angeles, CA
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Los Angeles, CA
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Miami, FL
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Murray, UT
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Nashville, TN
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Nashville, TN
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New York, NY
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New York, NY
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Newark, NJ
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Norfolk, VA
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875 Ellicott Street
NY, New York 14203
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NY, NY
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Philadelphia, PA
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Philadelphia, PA
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Phoenix, AZ
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Rocky Mount, NC
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Springfield, Massachusetts 01199
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Springfield, MA
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Statesville, North Carolina 28677
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Statesville, NC
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Tampa, FL
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Vineland, NJ
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West Palm Beach, FL
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Winston Salem, North Carolina 27157
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Winston Salem, NC
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