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

NCT02068963 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 352

Last updated 2016-02-04

No results posted yet for this 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

  • Hepatitis C

Sponsors & Collaborators

  • Hologic, Inc.

    lead INDUSTRY

Principal Investigators

  • Christine Kuslich · Hologic, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-04-30
Completion
2015-12-31

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02068963 on ClinicalTrials.gov