Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay
Public ClinicalTrials.gov record NCT02167113. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02167113
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 331 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2014
- Primary completion
- Jan 31, 2016
- Completion
- Jan 22, 2018
- Last update posted
- Jul 31, 2018
2014 – 2018
United States locations
- U.S. sites
- 38
- U.S. states
- 20
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner Health Good Samaritan | Phoenix | Arizona | 85006 | — |
| Dignity Health - St. Joseph's Hospital | Phoenix | Arizona | 85013 | — |
| Advanced Rx Clinical Research | Garden Grove | California | 92843 | — |
| High Desert Gastroenterology | Lancaster | California | 93534 | — |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | — |
| Stanford University Medical Center | Palo Alto | California | 94304 | — |
| Inland Empire Liver Foundation | Rialto | California | 92377 | — |
| Kaiser Permanente | San Diego | California | 92154 | — |
| Kaiser Foundation Hospital | San Francisco | California | 94115 | — |
| San Jose Gastroenterology | San Jose | California | 95116 | — |
| South Bay Gastroenterology Medical Group | Torrance | California | 90505 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | — |
| Schiff Center for Liver Disease | Miami | Florida | 33136 | — |
| Digestive Healthcare of Georgia | Atlanta | Georgia | 30309 | — |
| Gastrointestinal Specialists of Georgia | Marietta | Georgia | 30060 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| Digestive Disease Associates, PA | Catonsville | Maryland | 21228 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Newton-Wellesley Hospital | Newton | Massachusetts | 02462 | — |
| The Research Institute | Springfield | Massachusetts | 01105-1406 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| University of Medicine and Dentistry of New Jersey | Newark | New Jersey | 07103 | — |
| Sing Chan, MD | Flushing | New York | 11355 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| Carolinas HealthCare System | Charlotte | North Carolina | 28204 | — |
| Piedmont HealthCare | Statesville | North Carolina | 28677 | — |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | — |
| Einstein Healthcare Network | Philadelphia | Pennsylvania | 19141 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Nashville Medical Research Institute | Nashville | Tennessee | 37205 | — |
| Austin Center for Clinical Research | Austin | Texas | 78756 | — |
| Kelsey Research Foundation | Houston | Texas | 77005 | — |
| Liver Associates of Texas | Houston | Texas | 77030 | — |
| University of Utah School of Medicine | Salt Lake City | Utah | 84132 | — |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | — |
| Harborview Medical Center | Seattle | Washington | 98104 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 52 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02167113, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 31, 2018 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02167113 live on ClinicalTrials.gov.