Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay
- Conditions
- Hepatitis B, Chronic
- Registration Number
- NCT02167113
- Lead Sponsor
- Hologic, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 331
- 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)
-
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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). 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.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). 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (88)
Kaiser Permanente
🇺🇸San Diego, California, United States
South Bay Gastroenterology Medical Group
🇺🇸Torrance, California, United States
Schiff Center for Liver Disease
🇺🇸Miami, Florida, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Piedmont HealthCare
🇺🇸Statesville, North Carolina, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Einstein Healthcare Network
🇺🇸Philadelphia, Pennsylvania, United States
Liver Associates of Texas
🇺🇸Houston, Texas, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Liverpool Hospital, Department of Gastroenterology
🇦🇺Sydney, New South Wales, Australia
Toronto Liver Centre
🇨🇦Toronto, Ontario, Canada
Kaiser Foundation Hospital
🇺🇸San Francisco, California, United States
University of Utah School of Medicine
🇺🇸Salt Lake City, Utah, United States
Austin Center for Clinical Research
🇺🇸Austin, Texas, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Nashville Medical Research Institute
🇺🇸Nashville, Tennessee, United States
Advanced Rx Clinical Research
🇺🇸Garden Grove, California, United States
Lair Centre
🇨🇦Vancouver,, British Columbia, Canada
Napean Hospital, Gastroenterology and Hepatology Department
🇦🇺Kingswood, New South Wales, Australia
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Istanbul University Cerrahpaşa School of Medicine
🇹🇷Istanbul, Istanbul Province, Turkey
Kocaeli University School of Medicine
🇹🇷Kocaeli, Turkey
High Desert Gastroenterology
🇺🇸Lancaster, California, United States
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Digestive Disease Associates, PA
🇺🇸Catonsville, Maryland, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Digestive Healthcare of Georgia
🇺🇸Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia
🇺🇸Marietta, Georgia, United States
University of Medicine and Dentistry of New Jersey
🇺🇸Newark, New Jersey, United States
Sing Chan, MD
🇺🇸Flushing, New York, United States
Newton-Wellesley Hospital
🇺🇸Newton, Massachusetts, United States
The Research Institute
🇺🇸Springfield, Massachusetts, United States
Universitätsklinikum Essen Klinik für Gastroenterologie und Hepatologie
🇩🇪Essen, Germany
Carolinas HealthCare System
🇺🇸Charlotte, North Carolina, United States
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
San Jose Gastroenterology
🇺🇸San Jose, California, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
ifi-Studien und Projekte GmbH An der Asklepios Klinik St. Georg, Haus L
🇩🇪Hamburg, Germany
ifi-Studien und Projekte GmbH, An der Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
UMHAT Sveti Ivan Rilski Clinic of Gastroenterology
🇧🇬Sofia, Bulgaria
Medicina Interna - Ospedale Civile
🇮🇹Sassari, Italy
Auckland Liver Research Unit
🇳🇿Grafton, Auckland, New Zealand
Institutul Clinic Fundeni, Bucuresti
🇷🇴Sector 2, Bucuresti, Romania
Leberzentrum am Checkpoint Fachärztegemeinschaft für innere Krankheiten
🇩🇪Berlin, Germany
GI Research Institute
🇨🇦Vancouver, British Columbia, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
🇩🇪Berlin, Germany
Szent János Kórház
🇭🇺Budapest, Hungary
UMHAT Dr. Gerogi Stranski, Clinic of Gastroenterology
🇧🇬PLeven, Bulgaria
UMHAT Aleksandrovska, Clinic of Gastroenterology
🇧🇬Sofia, Bulgaria
Universitätsmedizin Mannheim II. Medizinische Klinik
🇩🇪Mannheim, Germany
'Ospdale Da Procida
🇮🇹Salerno, Italy
'Medicina Interna - Ospedale Civile
🇮🇹Sassari, Italy
Institutul de Boli Infectioase "Prof. Dr. Matei Bals"
🇷🇴Sector 2, Bucuresti, Romania
Spitalul Universitar de Urgenta Bucuresti
🇷🇴Sector 5, Bucuresti, Romania
Spitalul Clinic Judetean de Urgenta Sibiu
🇷🇴Sibiu, Jud. Sibiu, Romania
Spitalul Clininc de Boli Infecţioase Constanţa
🇷🇴Constanta, Judetul Constanta, Romania
Uludag University School of Medicine
🇹🇷Bursa, Turkey
Kelsey Research Foundation
🇺🇸Houston, Texas, United States
Dokuz Eylül University School of Medicine
🇹🇷Izmir, Turkey
St Vincent's Hospital Department of Gastroenterology
🇦🇺Fitzroy, Victoria, Australia
Zentrum für Infektiologie Berlin Prenzlauer Berg
🇩🇪Berlin, Germany
Szent István és Szent László Kórház
🇭🇺Budapest, Hungary
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Pándy Kálmán Megyei Kórház
🇭🇺Gyula, Hungary
Yıldırım Beyazıt University Atatürk Training and Research Hospital
🇹🇷Ankara, Turkey
Adnan Menderes Üniversitesi
🇹🇷Aydin, Turkey
Dicle University School of Medicine
🇹🇷Diyarbakir, Turkey
Budai Hepatollógiai Központ
🇭🇺Budapest, Hungary
Waikato Gastroenterology and Respiratory Research Office
🇳🇿Hamilton West, Waikato, New Zealand
Gastroenterology Research, Wellington Hospital
🇳🇿Newton, Wellington, New Zealand
Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"
🇷🇴Sector 1, Bucuresti, Romania
Policlinica Algomed, Timisoara
🇷🇴Timisoara, Jud. Timis, Romania
Ankara University School of Medicine
🇹🇷Ankara, Turkey
Selçuk University School of Medicine
🇹🇷Konya, Turkey
Ondokuz Mayıs University School of Medicine
🇹🇷Samsun, Turkey
Karadeniz Technical University School of Medicine
🇹🇷Trabzon, Turkey
Osmangazi University School of Medicine
🇹🇷Eskişehir, Turkey
Istanbul University Istanbul School of Medicine
🇹🇷Istanbul, Turkey
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Banner Health Good Samaritan
🇺🇸Phoenix, Arizona, United States
Dignity Health - St. Joseph's Hospital
🇺🇸Phoenix, Arizona, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States