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
158
mi
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Tulsa, OK
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900 East 30th Street
Austin, Texas 78705
512-480-9660
515
mi
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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...
1410
mi
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Seattle, WA
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Annapolis, Maryland 21401
1155
mi
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Annapolis, MD
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Asheville, North Carolina 28801
857
mi
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Asheville, NC
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Atlanta, Georgia 30342
798
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Atlanta, GA
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517
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Austin, TX
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Bakersfield, California 93301
1184
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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...
1149
mi
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Baltimore, MD
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Brockton, Massachusetts 02302
1445
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Brockton, MA
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Charleston, South Carolina 29414
1064
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...
1052
mi
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Durham, NC
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Englewood, Colorado 80113
408
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Englewood, CO
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Fayetteville, North Carolina 28304
1063
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Houston, Texas 77004
572
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Houston, TX
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Houston, Texas 77030
572
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Houston, TX
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Houston, Texas 77030
572
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Houston, TX
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646
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Indianapolis, IN
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Kansas City, Missouri 64131
194
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1021
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Lynchburg, VA
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Marietta, Georgia 30060
788
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Marietta, GA
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Miami, Florida 33136
1320
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Miami, FL
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Nashville, Tennessee 37205
615
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Nashville, TN
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Nashville, Tennessee 37211
623
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New Haven, Connecticut 06520
1344
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Norfolk, Virginia 23502
1186
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North Little Rock, Arkansas
371
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North Little Rock, AR
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Rialto, California 92377
1120
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Rialto, CA
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San Antonio, Texas 78215
575
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San Antonio, TX
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San Francisco, California 94115
1340
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San Francisco, CA
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2333
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San Juan,
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Springfield, Massachusetts 01107
1364
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Springfield, MA
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Upland, California 91786
1135
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Upland, CA
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Ventura, California 93003
1216
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Ventura, CA
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