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Completed No phase listed Observational

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

ClinicalTrials.gov ID: NCT02167113

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.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 5:10 AM EDT

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
Lead sponsor
Hologic, Inc.
Industry
Enrollment
331 participants

Conditions and interventions

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.

View official ClinicalTrials.gov record →