Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing



Status:Completed
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2014
End Date:December 2015

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Collection of Plasma and Serum Samples From Individuals Initiating Therapy With Sofosbuvir for Chronic Hepatitis C Virus Infection for the Clinical Evaluation of the Aptima HCV Quant Dx Assay

This non-interventional clinical study will be conducted to prospectively collect serial
plasma and serum samples from treatment naïve subjects with chronic HCV infection who are
initiating sofosbuvir-based therapy. These samples will be used to estimate clinical utility
endpoints for the Aptima HCV Quant Dx assay which is used an aid in the management of
HCV-infected patients undergoing HCV antiviral therapy.


Inclusion Criteria:

- The subject is chronically infected with HCV genotypes 1, 2, 3, 4, 5, and/or 6 as
documented in the subject's medical records and is naïve to HCV treatment (treatment
naïve).

- Chronic HCV (with or without HIV [human immunodeficiency virus] co-infection) will be
documented with historical record of:

- A positive HCV RNA test result (result generated at least 6 months before the
baseline visit)

- A HCV genotype test result (result generated at least 6 months before the baseline
visit)

- A liver biopsy report demonstrating chronic HCV

---The subject is initiating antiviral therapy with a sofosbuvir regimen as indicated
below:

- Sofosbuvir plus peginterferon and ribavirin for 12 weeks (peginterferon eligible
genotype 1, 4, 5, or 6)

- Sofosbuvir plus ribavirin for 12 weeks (genotype 2)

- Sofosbuvir plus ribavirin for 24 weeks (peginterferon ineligible or unwilling
genotype 1 or genotype 3)

- The subject is at least 18 years of age at the time of enrollment

- Adequate medical records are available for collection of protocol-defined
demographics, baseline patient characteristics, medical history, virology and
specific laboratory results, and other information to verify enrollment criteria

- The subject and/or legally authorized representative is willing and able to provide
consent prior to providing a specimen(s)

Exclusion Criteria:

- Subjects with history or evidence of decompensated liver disease

- Subjects with severe renal impairment or end stage renal disease

- Subjects who are not naïve to HCV therapy with prior exposure to an approved or
experimental HCV antiviral therapy

- Subject has characteristics that are contraindicated in the FDA approved label for
sofosbuvir (eg, subjects with contraindications applicable to peginterferon and/or
ribavirin, pregnant woman or men whose female partners are pregnant; Sovaldi Package
Insert 2013)

- Subject is receiving treatment pre- or post-transplant

- Subject is unsuitable for study participation based on the Investigator's decision
(eg, unlikely to comply with study visit schedule, significant medical complication)

- Participating in another investigational study that the Investigator believes might
interfere with the subject's participation in this study
We found this trial at
34
sites
Tulsa, Oklahoma 74137
1567
mi
from 98109
Tulsa, OK
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900 East 30th Street
Austin, Texas 78705
512-480-9660
1770
mi
from 98109
Austin, TX
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
2
mi
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Seattle, WA
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Annapolis, Maryland 21401
2343
mi
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Annapolis, MD
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Asheville, North Carolina 28801
2187
mi
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Asheville, NC
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Atlanta, Georgia 30342
2174
mi
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Atlanta, GA
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1770
mi
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Austin, TX
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Bakersfield, California 93301
863
mi
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Bakersfield, CA
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
2328
mi
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Baltimore, MD
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Brockton, Massachusetts 02302
2495
mi
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Brockton, MA
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Charleston, South Carolina 29414
2423
mi
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Charleston, SC
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
2341
mi
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Durham, NC
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Englewood, Colorado 80113
1024
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Englewood, CO
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Fayetteville, North Carolina 28304
2376
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Fayetteville, NC
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Houston, Texas 77004
1892
mi
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Houston, TX
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Houston, Texas 77030
1892
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Houston, TX
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Houston, Texas 77030
1892
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Houston, TX
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1874
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Indianapolis, IN
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Kansas City, Missouri 64131
1509
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Kansas City, MO
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2277
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Lynchburg, VA
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Marietta, Georgia 30060
2164
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Marietta, GA
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Miami, Florida 33136
2730
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Miami, FL
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Nashville, Tennessee 37205
1969
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Nashville, TN
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Nashville, Tennessee 37211
1976
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Nashville, TN
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New Haven, Connecticut 06520
2432
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New Haven, CT
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Norfolk, Virginia 23502
2434
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Norfolk, VA
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North Little Rock, Arkansas
1782
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North Little Rock, AR
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Rialto, California 92377
965
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Rialto, CA
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San Antonio, Texas 78215
1786
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San Antonio, TX
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San Francisco, California 94115
680
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San Francisco, CA
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3728
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San Juan,
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Springfield, Massachusetts 01107
2423
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Springfield, MA
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Upland, California 91786
965
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Upland, CA
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Ventura, California 93003
935
mi
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Ventura, CA
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