Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing
1 other identifier
observational
352
2 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2014
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 14, 2014
CompletedFirst Posted
Study publicly available on registry
February 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 4, 2016
February 1, 2016
1.2 years
February 14, 2014
February 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Sustained viral response based on lower limit of quantitation
Sustained viral response (SVR) is defined as viral load level being below the investigational assay's lower limit of quantitation.
12 weeks post therapy
Study Arms (1)
Study Population
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hologic, Inc.lead
Study Sites (34)
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117, United States
Franco Felizarta, MD
Bakersfield, California, 93301, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
Kaiser Permanente
San Francisco, California, 94118, United States
Empire Clinical Research
Upland, California, 91786, United States
Island View Gastroenterology
Ventura, California, 93003, United States
South Denver Gastroenterology, PC
Englewood, Colorado, 80113, United States
Yale School of Medicine
New Haven, Connecticut, 06510, United States
Schiff Center for Liver Disease
Miami, Florida, 33136, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30308, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060, United States
Indianapolis Gastroenterology Research Facility
Indianapolis, Indiana, 46237, United States
Investigative Clinical Research
Annapolis, Maryland, 21401, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, 02302, United States
The Research Institute
Springfield, Massachusetts, 01105, United States
Kansas City Gastroenterology
Kansas City, Missouri, 64131, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28304, United States
Options Health Research, LLC
Tulsa, Oklahoma, 74104, United States
Charleston GI Specialists
Charleston, South Carolina, 29414, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
Quality Medical Research, PLLC
Nashville, Tennessee, 37211, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Austin Center for Clinical Research
Austin, Texas, 78756, United States
Cure C Consortium
Houston, Texas, 77004, United States
Liver Associates of Texas, P.A.
Houston, Texas, 77030, United States
Research Specialists of Texas
Houston, Texas, 77030, United States
The Texas Liver Institute
San Antonio, Texas, 78215, United States
Infectious Diseases Associates of Central Virginia
Lynchburg, Virginia, 24501, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
University of Washington
Seattle, Washington, 98104, United States
Fundacion de Investigacion de Diego
San Juan, 00927, Puerto Rico
Biospecimen
Plasma and serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christine Kuslich
Hologic, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2014
First Posted
February 21, 2014
Study Start
February 1, 2014
Primary Completion
April 1, 2015
Study Completion
December 1, 2015
Last Updated
February 4, 2016
Record last verified: 2016-02