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
875 Ellicott Street
NY, New York 14203
295
mi
from 43215
NY, NY
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1069
mi
from 43215
Austin, TX
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1980
mi
from 43215
Bakersfield, CA
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344
mi
from 43215
Baltimore, MD
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344
mi
from 43215
Baltimore, MD
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Beverly Hills, California 90211
1979
mi
from 43215
Beverly Hills, CA
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478
mi
from 43215
Brooklyn, NY
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98
mi
from 43215
Cincinnati, OH
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Crestview Hills, Kentucky 41017
105
mi
from 43215
Crestview Hills, KY
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910
mi
from 43215
Dallas, TX
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749
mi
from 43215
Daytona Beach, FL
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?
mi
from 43215
DeLand, FL
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417
mi
from 43215
Doylestown, PA
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354
mi
from 43215
Durham, NC
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Fayetteville, North Carolina 28304
408
mi
from 43215
Fayetteville, NC
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487
mi
from 43215
Flushing, NY
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937
mi
from 43215
Fort Worth, TX
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991
mi
from 43215
Houston, TX
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991
mi
from 43215
Houston, TX
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1972
mi
from 43215
Los Angeles, CA
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1972
mi
from 43215
Los Angeles, CA
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993
mi
from 43215
Miami, FL
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1514
mi
from 43215
Murray, UT
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331
mi
from 43215
Nashville, TN
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331
mi
from 43215
Nashville, TN
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481
mi
from 43215
New York, NY
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481
mi
from 43215
New York, NY
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468
mi
from 43215
Newark, NJ
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422
mi
from 43215
Norfolk, VA
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416
mi
from 43215
Philadelphia, PA
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416
mi
from 43215
Philadelphia, PA
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1662
mi
from 43215
Phoenix, AZ
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397
mi
from 43215
Rocky Mount, NC
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Springfield, Massachusetts 01199
563
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Springfield, MA
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Statesville, North Carolina 28677
312
mi
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Statesville, NC
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831
mi
from 43215
Tampa, FL
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425
mi
from 43215
Vineland, NJ
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931
mi
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West Palm Beach, FL
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Winston Salem, North Carolina 27157
312
mi
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Winston Salem, NC
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