Hepatitis BNCT03123159
Clinical Performance Evaluation of DxN HBV Assay
An observational study of Hepatitis B, run by Beckman Coulter, Inc. at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B
- What is being tested?
- DxN HBV Assay
- How many people
- 60 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 27 May 2014to 30 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Subjects 18 years of age or older with chronic HBV who will undergo antiviral therapy to treat HBV infections
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
Baylor College of Medicine
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
St. Luke's Lipid and Diabetes Research Center
Kansas City, Missouri, 64111
Scripps Clinic
La Jolla, California, 92037
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
Weill Cornell Medical College
New York, New York, 10065
Albert Einstein Medical School
Philadelphia, Pennsylvania, 19141
University of Washington / Harborview Medical Center
Seattle, Washington, 98104
Canada2 sites
Centre Hospitalier de l'universite de Montreal
Montreal, Quebec
University Health Network
Toronto, Ontario
About this study
Official title: Clinical Utility of the DxN HBV Assay as an Aid in the Management of HBV-Infected Individuals Undergoing Antiviral Therapy
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.
Read the detailed description
Same as brief summary.
- Conditions
- Hepatitis B
- Being tested
- DxN HBV Assay
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DxN HBV AssayDiagnostic test
Molecular diagnostic test to detect Hepatitis B
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: DxN HBV Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Response (SVR)
Defined as unquantifiable HBV Viral load at 48 weeks of treatment.
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start27 May 2014
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lori Lofaro, MSHS, Study chair, Beckman Coulter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123159
- Sponsor's protocol ID
- HBV-02-13
- Status last verified
- Jul 2018
- First submitted
- 17 Apr 2017
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of the DxN HBV Assay as an Aid in the Management of HBV-Infected Individuals Undergoing Antiviral Therapy
- ClinicalTrials.gov ID
- NCT03123159
- Acronym / sponsor ID
- HBV-02-13
- Conditions
- Hepatitis B
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 May 2014 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Same as brief summary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBV Infected patients | – | Diagnostic Test: DxN HBV Assaychronic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects 18 years of age or older with chronic HBV who will undergo antiviral therapy to treat HBV infections
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DxN HBV AssayMolecular diagnostic test to detect Hepatitis B | Diagnostic test | HBV Infected patients |
Primary outcome
Sustained Virologic Response (SVR)
Time frame: Up to 48 weeks
Defined as unquantifiable HBV Viral load at 48 weeks of treatment.
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Lofaro, MSHS study chair
Beckman Coulter
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by Beckman Coulter, Inc. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Virologic Response (SVR) (time frame: Up to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018; AzTrials last refreshed its copy on 4 Nov 2026.