Clinical trial NCT02068963: Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-21
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treatment naïve men and women ≥18 years of age with chronic HCV infection initiating sofosbuvir-based treatment will be enrolled from medical facilities that may include private and academic family practice, infectious disease, hepatology, gastroenterology, and medical group clinics.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Sustained viral response based on lower limit of quantitation
timeFrame: 12 weeks post therapy
Secondary outcomes:
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Bakersfield
country: United States
facility: Franco Felizarta, MD
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
city: Upland
country: United States
facility: Empire Clinical Research
state: California
city: Ventura
country: United States
facility: Island View Gastroenterology
state: California
city: Englewood
country: United States
facility: South Denver Gastroenterology, PC
state: Colorado
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Miami
country: United States
facility: Schiff Center for Liver Disease
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia
state: Georgia
city: Indianapolis
country: United States
facility: Indianapolis Gastroenterology Research Facility
state: Indiana
city: Annapolis
country: United States
facility: Investigative Clinical Research
state: Maryland
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Brockton
country: United States
facility: Commonwealth Clinical Studies
state: Massachusetts
city: Springfield
country: United States
facility: The Research Institute
state: Massachusetts
city: Kansas City
country: United States
facility: Kansas City Gastroenterology
state: Missouri
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, PA
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
city: Tulsa
country: United States
facility: Options Health Research, LLC
state: Oklahoma
city: Charleston
country: United States
facility: Charleston GI Specialists
state: South Carolina
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research, PLLC
state: Tennessee
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Austin
country: United States
facility: Austin Center for Clinical Research
state: Texas
city: Houston
country: United States
facility: Cure C Consortium
state: Texas
city: Houston
country: United States
facility: Liver Associates of Texas, P.A.
state: Texas
city: Houston
country: United States
facility: Research Specialists of Texas
state: Texas
city: San Antonio
country: United States
facility: The Texas Liver Institute
state: Texas
city: Lynchburg
country: United States
facility: Infectious Diseases Associates of Central Virginia
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Hologic, Inc.
name: Christine Kuslich
role: STUDY_DIRECTOR
References: