Trials / Completed
CompletedNCT02167113
Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay
Collection of Plasma Samples From Individuals Initiating Therapy With Entecavir or Tenofovir for Chronic Hepatitis B Virus Infection for the Clinical Evaluation of the Aptima HBV Quant Assay
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 331 (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 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
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2016-02-01
- Completion
- 2018-01-23
- First posted
- 2014-06-18
- Last updated
- 2018-08-01
Locations
90 sites across 10 countries: United States, Australia, Bulgaria, Canada, Germany, Hungary, Italy, New Zealand, Romania, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT02167113. Inclusion in this directory is not an endorsement.