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Completed No phase listed Observational

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

ClinicalTrials.gov ID: NCT02068963

Public ClinicalTrials.gov record NCT02068963. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 11, 2026, 4:56 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02068963
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Hologic, Inc.
Industry
Enrollment
352 participants

Conditions and interventions

Conditions

Interventions

Not listed

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2014
Primary completion
Mar 31, 2015
Completion
Nov 30, 2015
Last update posted
Feb 3, 2016

2014 – 2015

United States locations

U.S. sites
33
U.S. states
17
U.S. cities
29
Facility City State ZIP Site status
Arkansas Gastroenterology North Little Rock Arkansas 72117
Franco Felizarta, MD Bakersfield California 93301
Inland Empire Liver Foundation Rialto California 92377
Kaiser Permanente San Francisco California 94118
Empire Clinical Research Upland California 91786
Island View Gastroenterology Ventura California 93003
South Denver Gastroenterology, PC Englewood Colorado 80113
Yale School of Medicine New Haven Connecticut 06510
Schiff Center for Liver Disease Miami Florida 33136
Atlanta Gastroenterology Associates Atlanta Georgia 30308
Gastrointestinal Specialists of Georgia Marietta Georgia 30060
Indianapolis Gastroenterology Research Facility Indianapolis Indiana 46237
Investigative Clinical Research Annapolis Maryland 21401
Mercy Medical Center Baltimore Maryland 21202
Commonwealth Clinical Studies Brockton Massachusetts 02302
The Research Institute Springfield Massachusetts 01105
Kansas City Gastroenterology Kansas City Missouri 64131
Asheville Gastroenterology Associates, PA Asheville North Carolina 28801
Duke University Medical Center Durham North Carolina 27710
Cumberland Research Associates, LLC Fayetteville North Carolina 28304
Options Health Research, LLC Tulsa Oklahoma 74104
Charleston GI Specialists Charleston South Carolina 29414
Nashville Medical Research Institute Nashville Tennessee 37205
Quality Medical Research, PLLC Nashville Tennessee 37211
Central Texas Clinical Research Austin Texas 78705
Austin Center for Clinical Research Austin Texas 78756
Cure C Consortium Houston Texas 77004
Liver Associates of Texas, P.A. Houston Texas 77030
Research Specialists of Texas Houston Texas 77030
The Texas Liver Institute San Antonio Texas 78215
Infectious Diseases Associates of Central Virginia Lynchburg Virginia 24501
Digestive and Liver Disease Specialists Norfolk Virginia 23502
University of Washington Seattle Washington 98104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02068963, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 3, 2016 · Synced Sep 11, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02068963 live on ClinicalTrials.gov.

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