Trials / Completed
CompletedNCT02068963
Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 352 (actual)
- Sponsor
- Hologic, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2015-04-01
- Completion
- 2015-12-01
- First posted
- 2014-02-21
- Last updated
- 2016-02-04
Locations
34 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT02068963. Inclusion in this directory is not an endorsement.