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NCT02167113 · ClinicalTrials.gov registry record
Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay
A clinical trial of Hepatitis B， Chronic, sponsored by Hologic.
- Completed
- Registry status
- 331
- Enrollment target
- 20
- Study locations
NCT02167113: Completed study of Hepatitis B， Chronic, sponsored by Hologic.
NCT02167113 is a study of Hepatitis B， Chronic that has completed, run by Hologic. The registered enrollment target is 331 participants, below the 551-participant average among 6 other Hepatitis B， Chronic trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02167113, a study of Hepatitis B， Chronic, has completed, sponsored by Hologic.
- COMPLETED
- Registry status
- 331 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Virologic response is defined as HBV DNA levels less than the lower limit of quantitation at the assessed time point. Association will be measured as an odds ratio.
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 |
What the finished NCT02167113 record still lists
NCT02167113 is an observational study that tracks outcomes without assigning an intervention. The registered 331 participants enrollment target is mid-sized for trials with a published cap, below the 551-participant average among 6 other Hepatitis B， Chronic trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Hepatitis B， Chronic appearing as the primary indexed condition, and to 0 interventions.
NCT02167113 names 20 study sites across 7 states, led by California, Massachusetts, Arizona.
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.
Who is sponsoring clinical trial NCT02167113?
This trial is sponsored by Hologic, which has 21 total clinical trials registered on ClinicalTrials.gov.
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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