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

Use our guide to learn which trials are right for you!

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
1112
mi
from
Rocky Mount, NC
Click here to add this to my saved trials
522
mi
from
Austin, TX
Click here to add this to my saved trials
1184
mi
from
Bakersfield, CA
Click here to add this to my saved trials
1148
mi
from
Baltimore, MD
Click here to add this to my saved trials
1148
mi
from
Baltimore, MD
Click here to add this to my saved trials
Beverly Hills, California 90211
1175
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
1287
mi
from
Brooklyn, NY
Click here to add this to my saved trials
726
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Crestview Hills, Kentucky 41017
721
mi
from
Crestview Hills, KY
Click here to add this to my saved trials
349
mi
from
Dallas, TX
Click here to add this to my saved trials
1128
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
?
mi
from
DeLand, FL
Click here to add this to my saved trials
1227
mi
from
Doylestown, PA
Click here to add this to my saved trials
1051
mi
from
Durham, NC
Click here to add this to my saved trials
Fayetteville, North Carolina 28304
1067
mi
from
Fayetteville, NC
Click here to add this to my saved trials
1296
mi
from
Flushing, NY
Click here to add this to my saved trials
346
mi
from
Fort Worth, TX
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
778
mi
from
Murray, UT
Click here to add this to my saved trials
618
mi
from
Nashville, TN
Click here to add this to my saved trials
618
mi
from
Nashville, TN
Click here to add this to my saved trials
1290
mi
from
New York, NY
Click here to add this to my saved trials
1290
mi
from
New York, NY
Click here to add this to my saved trials
1278
mi
from
Newark, NJ
Click here to add this to my saved trials
1181
mi
from
Norfolk, VA
Click here to add this to my saved trials
875 Ellicott Street
NY, New York 14203
1057
mi
from
NY, NY
Click here to add this to my saved trials
1225
mi
from
Philadelphia, PA
Click here to add this to my saved trials
1225
mi
from
Philadelphia, PA
Click here to add this to my saved trials
853
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Springfield, Massachusetts 01199
1364
mi
from
Springfield, MA
Click here to add this to my saved trials
Statesville, North Carolina 28677
945
mi
from
Statesville, NC
Click here to add this to my saved trials
1117
mi
from
Tampa, FL
Click here to add this to my saved trials
1232
mi
from
Vineland, NJ
Click here to add this to my saved trials
1284
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
Winston Salem, North Carolina 27157
979
mi
from
Winston Salem, NC
Click here to add this to my saved trials