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Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay

NCT02167113 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 331

Last updated 2018-08-01

No results posted yet for this study

Summary

This non-interventional clinical study will be conducted to prospectively collect serial plasma samples from subjects with chronic HBV infection who are initiating antiviral therapy. These samples will be used to estimate clinical utility endpoints for the Aptima HBV Quant assay, which is used as an aid in the management of HBV-infected patients undergoing HBV antiviral therapy.

Conditions

  • Hepatitis B, Chronic

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
2014-03-31
Primary Completion
2016-02-29
Completion
2018-01-23

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Germany
  • Hungary
  • Italy
  • New Zealand
  • Romania
  • Turkey (Türkiye)

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 NCT02167113 on ClinicalTrials.gov