Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay
NCT02167113 · View on ClinicalTrials.gov ↗
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 Studied
Study Locations (20)
California
- Advanced Rx Clinical Research — Garden Grove
- High Desert Gastroenterology — Lancaster
- Kaiser Permanente Los Angeles Medical Center — Los Angeles
- Stanford University Medical Center — Palo Alto
- Inland Empire Liver Foundation — Rialto
- Kaiser Permanente — San Diego
- Kaiser Foundation Hospital — San Francisco
- San Jose Gastroenterology — San Jose
- South Bay Gastroenterology Medical Group — Torrance
Massachusetts
- Beth Israel Deaconess Medical Center — Boston
- Newton-Wellesley Hospital — Newton
- The Research Institute — Springfield
Arizona
- Banner Health Good Samaritan — Phoenix
- Dignity Health - St. Joseph's Hospital — Phoenix
Georgia
- Digestive Healthcare of Georgia — Atlanta
- Gastrointestinal Specialists of Georgia — Marietta
Maryland
- Mercy Medical Center — Baltimore
- Digestive Disease Associates, PA — Catonsville
Connecticut
- Yale University School of Medicine — New Haven
Florida
- Schiff Center for Liver Disease — Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 331 participants |
| Start Date | 2014-03 |
| Est. Completion | 2018-01-23 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02167113
The ClinicalTrials.gov registry entry for NCT02167113 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 331 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hologic, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hepatitis B, Chronic appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02167113 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Massachusetts, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02167113 about?
NCT02167113 is a clinical study titled "Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay". 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...
What is the current status of trial NCT02167113?
This trial is currently completed. The enrollment target is 331 participants. The study started on 2014-03. Estimated completion is 2018-01-23.
What conditions does trial NCT02167113 study?
This clinical trial studies the following conditions: Hepatitis B, Chronic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT02167113?
This trial is sponsored by Hologic, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02167113 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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