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

July 31, 2018 updated by: Hologic, Inc.

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

331

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Kingswood, New South Wales, Australia, 2747
        • Napean Hospital, Gastroenterology and Hepatology Department
      • Sydney, New South Wales, Australia, 2170
        • Liverpool Hospital, Department of Gastroenterology
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital Department of Gastroenterology
  • Bulgaria
      • PLeven, Bulgaria, 5800
        • UMHAT Dr. Gerogi Stranski, Clinic of Gastroenterology
      • Sofia, Bulgaria, 1431
        • UMHAT Aleksandrovska, Clinic of Gastroenterology
      • Sofia, Bulgaria, 1431
        • UMHAT Sveti Ivan Rilski Clinic of Gastroenterology
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Foothills Medical Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GI Research Institute
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • University of British Columbia
      • Vancouver,, British Columbia, Canada, V5Z 1H2
        • Lair Centre
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre
      • Toronto, Ontario, Canada, M6H 3M1
        • Toronto Liver Centre
  • Germany
      • Berlin, Germany, 13353
        • Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
      • Berlin, Germany, 10969
        • Leberzentrum am Checkpoint Fachärztegemeinschaft für innere Krankheiten
      • Berlin, Germany, 13353
        • Zentrum für Infektiologie Berlin Prenzlauer Berg
      • Essen, Germany, 45122
        • Universitätsklinikum Essen Klinik für Gastroenterologie und Hepatologie
      • Hamburg, Germany, 20099
        • ifi-Studien und Projekte GmbH An der Asklepios Klinik St. Georg, Haus L
      • Hamburg, Germany, 20099
        • Ifi-Studien und Projekte GmbH, An der Asklepios Klinik St. Georg
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • Mannheim, Germany, 68167
        • Universitätsmedizin Mannheim II. Medizinische Klinik
  • Hungary
      • Budapest, Hungary, 1125
        • Szent János Kórház
      • Budapest, Hungary
        • Szent János Kórház
      • Budapest, Hungary, 1097
        • Szent István és Szent László Kórház
      • Budapest, Hungary, 1111
        • Budai Hepatollógiai Központ
      • Budapest, Hungary
        • Budai Hepatollógiai Központ
      • Gyula, Hungary, 5700
        • Pándy Kálmán Megyei Kórház
  • Italy
      • Salerno, Italy
        • 'Ospdale Da Procida
      • Sassari, Italy
        • 'Medicina Interna - Ospedale Civile
      • Sassari, Italy
        • Medicina Interna - Ospedale Civile
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1142
        • Auckland Liver Research Unit
    • Waikato
      • Hamilton West, Waikato, New Zealand, 3024
        • Waikato Gastroenterology and Respiratory Research Office
    • Wellington
      • Newton, Wellington, New Zealand, 6021
        • Gastroenterology Research, Wellington Hospital
  • Romania
    • Bucuresti
      • Sector 1, Bucuresti, Romania, 010825
        • Spitalul Universitar De Urgenta Militar Central "Dr. Carol Davila"
      • Sector 2, Bucuresti, Romania, 021105
        • Institutul de Boli Infectioase "Prof. Dr. Matei Bals"
      • Sector 2, Bucuresti, Romania
        • Institutul Clinic Fundeni, Bucuresti
      • Sector 5, Bucuresti, Romania
        • Spitalul Universitar de Urgenta Bucuresti
    • Jud. Sibiu
      • Sibiu, Jud. Sibiu, Romania
        • Spitalul Clinic Judetean de Urgenta Sibiu
    • Jud. Timis
      • Timisoara, Jud. Timis, Romania
        • Policlinica Algomed, Timisoara
    • Judetul Constanta
      • Constanta, Judetul Constanta, Romania
        • Spitalul Clininc de Boli Infecţioase Constanţa
  • Turkey
      • Ankara, Turkey, 06620
        • Ankara University School of Medicine
      • Ankara, Turkey
        • Yıldırım Beyazıt University Atatürk Training and Research Hospital
      • Aydin, Turkey, 09010
        • Adnan Menderes Üniversitesi
      • Bursa, Turkey, 16059
        • Uludag University School of Medicine
      • Diyarbakir, Turkey
        • Dicle University School of Medicine
      • Eskişehir, Turkey, 26040
        • Osmangazi University School of Medicine
      • Istanbul, Turkey, 34093
        • Istanbul University Istanbul School of Medicine
      • Izmir, Turkey, 35210
        • Dokuz Eylul University School of Medicine
      • Kocaeli, Turkey
        • Kocaeli University School of Medicine
      • Konya, Turkey, 42131
        • Selçuk University School of Medicine
      • Samsun, Turkey, 55139
        • Ondokuz Mayıs University School of Medicine
      • Trabzon, Turkey, 61080
        • Karadeniz Technical University School of Medicine
    • Istanbul Province
      • Istanbul, Istanbul Province, Turkey, 34098
        • Istanbul University Cerrahpaşa School of Medicine
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Health Good Samaritan
      • Phoenix, Arizona, United States, 85013
        • Dignity Health - St. Joseph's Hospital
    • California
      • Garden Grove, California, United States, 92843
        • Advanced Rx Clinical Research
      • Lancaster, California, United States, 93534
        • High Desert Gastroenterology
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Palo Alto, California, United States, 94304
        • Stanford University Medical Center
      • Rialto, California, United States, 92377
        • Inland Empire Liver Foundation
      • San Diego, California, United States, 92154
        • Kaiser Permanente
      • San Francisco, California, United States, 94115
        • Kaiser Foundation Hospital
      • San Jose, California, United States, 95116
        • San Jose Gastroenterology
      • Torrance, California, United States, 90505
        • South Bay Gastroenterology Medical Group
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School Of Medicine
    • Florida
      • Miami, Florida, United States, 33136
        • Schiff Center for Liver Disease
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Digestive Healthcare of Georgia
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
      • Catonsville, Maryland, United States, 21228
        • Digestive Disease Associates, PA
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Newton, Massachusetts, United States, 02462
        • Newton-Wellesley Hospital
      • Springfield, Massachusetts, United States, 01105-1406
        • The Research Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • University of Medicine and Dentistry of New Jersey
    • New York
      • Flushing, New York, United States, 11355
        • Sing Chan, MD
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Healthcare System
      • Statesville, North Carolina, United States, 28677
        • Piedmont Healthcare
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • INTEGRIS Baptist Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19141
        • Einstein Healthcare Network
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Nashville Medical Research Institute
    • Texas
      • Austin, Texas, United States, 78756
        • Austin Center for Clinical Research
      • Houston, Texas, United States, 77005
        • Kelsey Research Foundation
      • Houston, Texas, United States, 77030
        • Liver Associates of Texas
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah School of Medicine
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Treatment naïve men and women ≥18 years of age with chronic HBV infection initiating entecavir or tenofovir treatment.

Description

Inclusion Criteria:

  • The subject is chronically infected with HBV.The subject is treatment naïve and is initiating HBV antiviral therapy with either entecavir or tenofovir as indicated in the FDA approved label
  • The subject will be considered treatment naïve if he/she had <12 weeks of oral antiviral therapy with any nucleoside or nucleotide therapy
  • The subject is at least 18 years of age at the time of enrollment
  • Adequate medical records are available for collection of protocol-defined demographics, baseline patient characteristics, medical history, virology and specific laboratory results, and other information to verify enrollment criteria
  • The subject and/or legally authorized representative is willing and able to provide consent prior to providing a specimen(s)

Exclusion Criteria:

  • Subject is in one of the following patient populations:

    • Acute HBV infection
    • Patients who are HBV immune tolerant
    • Human immunodeficiency virus (HIV) and/or hepatitis C virus (HCV) co-infection
    • Solid organ or bone marrow transplant recipients
    • Renal failure or dialysis
    • Evidence or history of hepatic decompensation
    • Evidence or history of hepatocellular carcinoma
  • Underlying liver disease other than HBV
  • Receiving chemotherapy, immunosuppressive agents
  • Subject is unsuitable for study participation based on the Investigator's decision (eg, unlikely to comply with study visit schedule, significant medical complication)
  • Participating in another investigational study that the Investigator believes might interfere with the subject's participation in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
study population

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between virologic response at Week 12 (assessed using the Aptima HBV Quant assay) and virologic response at Week 48 (assessed using an FDA-approved HBV quant assay).
Time Frame: Week 48 (from start of therapy)

Virologic response is defined as HBV DNA levels less than the lower limit of quantitation at the assessed time point.

Association will be measured as an odds ratio.
Week 48 (from start of therapy)
Association between virologic response at Week 24 (assessed using the Aptima HBV Quant assay) and virologic response at Week 48 (assessed using an FDA-approved HBV quant assay).
Time Frame: Week 48 (from start of therapy)

Virologic response is defined as HBV DNA levels less than the lower limit of quantitation at the assessed time point.

Association will be measured as an odds ratio.
Week 48 (from start of therapy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hologic, Inc.

Investigators

  • Study Director: Christine Kuslich, Hologic, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

January 23, 2018

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V10434-HBVQPS-CSP-01 (Other Identifier: Hologic)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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