Study Stopped
Business decision
Clinical Performance Evaluation of DxN HBV Assay
Clinical Utility of the DxN HBV Assay as an Aid in the Management of HBV-Infected Individuals Undergoing Antiviral Therapy
1 other identifier
observational
60
2 countries
10
Brief Summary
The DxN Hepatitis B Virus (HBV) Assay is an in vitro diagnostic assay intended as an aid in the management of HBV-infected individuals undergoing antiviral therapy. The purpose of the study is to establish the clinical performance of the DxN HBV Assay for plasma samples in the intended use population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2014
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 27, 2014
CompletedFirst Submitted
Initial submission to the registry
April 17, 2017
CompletedFirst Posted
Study publicly available on registry
April 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2017
CompletedJuly 12, 2018
July 1, 2018
3.3 years
April 17, 2017
July 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Sustained Virologic Response (SVR)
Defined as unquantifiable HBV Viral load at 48 weeks of treatment.
Up to 48 weeks
Study Arms (1)
HBV Infected patients
chronic HBV patients who will undergo standard of care FDA approved antiviral therapy to treat HBV infections. Will have blood drawn to be tested using the DxN HBV Assay. Study is observational and results will not be used to manage patient care.
Interventions
Eligibility Criteria
Subjects 18 years of age or older with chronic HBV who will undergo antiviral therapy to treat HBV infections
You may qualify if:
- Subject is 18 years of age or older
- Subject has serological evidence of chronic HBV infection, and measurable HBV-DNA and ALT at baseline
- Subject will undergo treatment with tenofovir or entecavir for a minimum of 48 weeks
You may not qualify if:
- Co-infection with HIV or HCV at enrollment
- Subject has decompensated liver disease or liver cancer
- Prior participation in study
- Current or planned participation in an investigational drug or device study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Scripps Clinic
La Jolla, California, 92037, United States
University of Minnesota Medical School
Minneapolis, Minnesota, 55455, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
St. Luke's Lipid and Diabetes Research Center
Kansas City, Missouri, 64111, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Albert Einstein Medical School
Philadelphia, Pennsylvania, 19141, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Washington / Harborview Medical Center
Seattle, Washington, 98104, United States
University Health Network
Toronto, Ontario, Canada
Centre Hospitalier de l'universite de Montreal
Montreal, Quebec, Canada
Biospecimen
Frozen plasma samples are retained for this study and possible future studies.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lori Lofaro, MSHS
Beckman Coulter
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2017
First Posted
April 21, 2017
Study Start
May 27, 2014
Primary Completion
August 30, 2017
Study Completion
August 30, 2017
Last Updated
July 12, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share