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Trial record 139 of 311 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Clinical Performance Evaluation of DxN HBV Assay

This study is currently recruiting participants.
Verified April 2017 by Beckman Coulter, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03123159
First Posted: April 21, 2017
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Beckman Coulter, Inc.
  Purpose
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.

Condition Intervention
Hepatitis B Diagnostic Test: DxN HBV Assay

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Utility of the DxN HBV Assay as an Aid in the Management of HBV-Infected Individuals Undergoing Antiviral Therapy

Resource links provided by NLM:


Further study details as provided by Beckman Coulter, Inc.:

Primary Outcome Measures:
  • Sustained Virologic Response (SVR) [ Time Frame: Up to 48 weeks ]
    Defined as unquantifiable HBV Viral load at 48 weeks of treatment.


Biospecimen Retention:   Samples Without DNA
Frozen plasma samples are retained for this study and possible future studies.

Estimated Enrollment: 260
Actual Study Start Date: May 27, 2014
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Diagnostic Test: DxN HBV Assay
Molecular diagnostic test to detect Hepatitis B

Detailed Description:
Same as brief summary.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Subjects 18 years of age or older with chronic HBV who will undergo antiviral therapy to treat HBV infections
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123159


Contacts
Contact: Lori Lofaro, MSHS 760-438-6574 lrlofaro@beckman.com

Locations
United States, California
Scripps Clinic Recruiting
La Jolla, California, United States, 92037
United States, Minnesota
University of Minnesota Medical School Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
St. Luke's Lipid and Diabetes Research Center Recruiting
Kansas City, Missouri, United States, 64111
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
United States, Pennsylvania
Albert Einstein Medical School Recruiting
Philadelphia, Pennsylvania, United States, 19141
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
United States, Washington
University of Washington / Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada
Canada, Quebec
Centre Hospitalier de l'universite de Montreal Recruiting
Montreal, Quebec, Canada
Sponsors and Collaborators
Beckman Coulter, Inc.
Investigators
Study Chair: Lori Lofaro, MSHS Beckman Coulter
  More Information

Responsible Party: Beckman Coulter, Inc.
ClinicalTrials.gov Identifier: NCT03123159     History of Changes
Other Study ID Numbers: HBV-02-13
First Submitted: April 17, 2017
First Posted: April 21, 2017
Last Update Posted: April 21, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Hepatitis B
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases