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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: Completed study of Hepatitis C, sponsored by Hologic.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Sustained viral response (SVR) is defined as viral load level being below the investigational assay's lower limit of quantitation.
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 |
What the finished NCT02068963 record still lists
NCT02068963 is an observational study that tracks outcomes without assigning an intervention. The registered 352 participants enrollment target is mid-sized for trials with a published cap, below the 1,887-participant average among 106 other Hepatitis C trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 0 interventions.
NCT02068963 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
Similar trials for Hepatitis C
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02068963's enrollment target sits among peer trials
352 31st of 106 higher than 76 of 106 other Hepatitis C trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis C trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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