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NCT02068963 · ClinicalTrials.gov registry record
Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing
A clinical trial of Hepatitis C, sponsored by Hologic.
- Completed
- Registry status
- 352
- Enrollment target
- 20
- Study locations
NCT02068963 is a study of Hepatitis C that has completed, run by Hologic. The registered enrollment target is 352 participants, below the 1,887-participant average among 106 other Hepatitis C trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT02068963, a study of Hepatitis C, has completed, sponsored by Hologic.
- COMPLETED
- Registry status
- 352 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Study Locations (20)
California
- Franco Felizarta, MD - Bakersfield
- Inland Empire Liver Foundation - Rialto
- Kaiser Permanente - San Francisco
- Empire Clinical Research - Upland
- Island View Gastroenterology - Ventura
North Carolina
- Asheville Gastroenterology Associates, PA - Asheville
- Duke University Medical Center - Durham
- Cumberland Research Associates, LLC - Fayetteville
Georgia
- Atlanta Gastroenterology Associates - Atlanta
- Gastrointestinal Specialists of Georgia - Marietta
Maryland
- Investigative Clinical Research - Annapolis
- Mercy Medical Center - Baltimore
Massachusetts
- Commonwealth Clinical Studies - Brockton
- The Research Institute - Springfield
Arkansas
- Arkansas Gastroenterology - North Little Rock
Colorado
- South Denver Gastroenterology, PC - Englewood
Connecticut
- Yale School of Medicine - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 352 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02068963
The ClinicalTrials.gov registry entry for NCT02068963 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 352 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,887-participant average among 106 other Hepatitis C trials with a reported enrollment target (81% lower). The listed sponsor is Hologic, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 0 interventions.
NCT02068963 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, North Carolina, Georgia.
Frequently Asked Questions
What is clinical trial NCT02068963 about?
NCT02068963 is a clinical study titled "Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing". 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...
What is the current status of trial NCT02068963?
This trial is currently completed. The enrollment target is 352 participants. The study started on 2014-02. Estimated completion is 2015-12.
What conditions does trial NCT02068963 study?
This clinical trial studies the following conditions: Hepatitis C.
Who is sponsoring clinical trial NCT02068963?
This trial is sponsored by Hologic, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02068963 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.