Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay
HBVQuant
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
1 other identifier
observational
331
10 countries
90
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
Longer than P75 for all trials
90 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
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 12, 2014
CompletedFirst Posted
Study publicly available on registry
June 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 23, 2018
CompletedAugust 1, 2018
July 1, 2018
1.9 years
June 12, 2014
July 31, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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).
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).
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)
Study Arms (1)
study population
Eligibility Criteria
Treatment naïve men and women ≥18 years of age with chronic HBV infection initiating entecavir or tenofovir treatment.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hologic, Inc.lead
Study Sites (90)
Banner Health Good Samaritan
Phoenix, Arizona, 85006, United States
Dignity Health - St. Joseph's Hospital
Phoenix, Arizona, 85013, United States
Advanced Rx Clinical Research
Garden Grove, California, 92843, United States
High Desert Gastroenterology
Lancaster, California, 93534, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Stanford University Medical Center
Palo Alto, California, 94304, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
Kaiser Permanente
San Diego, California, 92154, United States
Kaiser Foundation Hospital
San Francisco, California, 94115, United States
San Jose Gastroenterology
San Jose, California, 95116, United States
South Bay Gastroenterology Medical Group
Torrance, California, 90505, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Schiff Center for Liver Disease
Miami, Florida, 33136, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Digestive Disease Associates, PA
Catonsville, Maryland, 21228, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Newton-Wellesley Hospital
Newton, Massachusetts, 02462, United States
The Research Institute
Springfield, Massachusetts, 01105-1406, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, 07103, United States
Sing Chan, MD
Flushing, New York, 11355, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Carolinas HealthCare System
Charlotte, North Carolina, 28204, United States
Piedmont HealthCare
Statesville, North Carolina, 28677, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
Austin Center for Clinical Research
Austin, Texas, 78756, United States
Kelsey Research Foundation
Houston, Texas, 77005, United States
Liver Associates of Texas
Houston, Texas, 77030, United States
University of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53705, United States
Napean Hospital, Gastroenterology and Hepatology Department
Kingswood, New South Wales, 2747, Australia
Liverpool Hospital, Department of Gastroenterology
Sydney, New South Wales, 2170, Australia
St Vincent's Hospital Department of Gastroenterology
Fitzroy, Victoria, 3065, Australia
UMHAT Dr. Gerogi Stranski, Clinic of Gastroenterology
Pleven, 5800, Bulgaria
UMHAT Aleksandrovska, Clinic of Gastroenterology
Sofia, 1431, Bulgaria
UMHAT Sveti Ivan Rilski Clinic of Gastroenterology
Sofia, 1431, Bulgaria
Foothills Medical Centre
Calgary, Alberta, T2N 4Z6, Canada
Lair Centre
Vancouver, British Columbia, V5Z 1H2, Canada
University of British Columbia
Vancouver, British Columbia, V5Z 1M9, Canada
GI Research Institute
Vancouver, British Columbia, V6Z 2K5, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
Toronto Liver Centre
Toronto, Ontario, M6H 3M1, Canada
Leberzentrum am Checkpoint Fachärztegemeinschaft für innere Krankheiten
Berlin, 10969, Germany
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
Berlin, 13353, Germany
Zentrum für Infektiologie Berlin Prenzlauer Berg
Berlin, 13353, Germany
Universitätsklinikum Essen Klinik für Gastroenterologie und Hepatologie
Essen, 45122, Germany
ifi-Studien und Projekte GmbH An der Asklepios Klinik St. Georg, Haus L
Hamburg, 20099, Germany
ifi-Studien und Projekte GmbH, An der Asklepios Klinik St. Georg
Hamburg, 20099, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Universitätsmedizin Mannheim II. Medizinische Klinik
Mannheim, 68167, Germany
Szent István és Szent László Kórház
Budapest, 1097, Hungary
Budai Hepatollógiai Központ
Budapest, 1111, Hungary
Szent János Kórház
Budapest, 1125, Hungary
Budai Hepatollógiai Központ
Budapest, Hungary
Szent János Kórház
Budapest, Hungary
Pándy Kálmán Megyei Kórház
Gyula, 5700, Hungary
'Ospdale Da Procida
Salerno, Italy
'Medicina Interna - Ospedale Civile
Sassari, Italy
Medicina Interna - Ospedale Civile
Sassari, Italy
Auckland Liver Research Unit
Grafton, Auckland, 1142, New Zealand
Waikato Gastroenterology and Respiratory Research Office
Hamilton West, Waikato Region, 3024, New Zealand
Gastroenterology Research, Wellington Hospital
Newton, Wellington Region, 6021, New Zealand
Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"
Sector 1, București, 010825, Romania
Institutul de Boli Infectioase "Prof. Dr. Matei Bals"
Sector 2, București, 021105, Romania
Institutul Clinic Fundeni, Bucuresti
Sector 2, București, Romania
Spitalul Universitar de Urgenta Bucuresti
Sector 5, București, Romania
Spitalul Clininc de Boli Infecţioase Constanţa
Constanța, Constanța County, Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, Jud. Sibiu, Romania
Policlinica Algomed, Timisoara
Timișoara, Jud. Timis, Romania
Istanbul University Cerrahpaşa School of Medicine
Istanbul, Istanbul, 34098, Turkey (Türkiye)
Ankara University School of Medicine
Ankara, 06620, Turkey (Türkiye)
Yıldırım Beyazıt University Atatürk Training and Research Hospital
Ankara, Turkey (Türkiye)
Adnan Menderes Üniversitesi
Aydin, 09010, Turkey (Türkiye)
Uludag University School of Medicine
Bursa, 16059, Turkey (Türkiye)
Dicle University School of Medicine
Diyarbakır, Turkey (Türkiye)
Osmangazi University School of Medicine
Eskişehir, 26040, Turkey (Türkiye)
Istanbul University Istanbul School of Medicine
Istanbul, 34093, Turkey (Türkiye)
Dokuz Eylül University School of Medicine
Izmir, 35210, Turkey (Türkiye)
Kocaeli University School of Medicine
Kocaeli, Turkey (Türkiye)
Selçuk University School of Medicine
Konya, 42131, Turkey (Türkiye)
Ondokuz Mayıs University School of Medicine
Samsun, 55139, Turkey (Türkiye)
Karadeniz Technical University School of Medicine
Trabzon, 61080, Turkey (Türkiye)
Biospecimen
Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christine Kuslich
Hologic, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2014
First Posted
June 18, 2014
Study Start
March 1, 2014
Primary Completion
February 1, 2016
Study Completion
January 23, 2018
Last Updated
August 1, 2018
Record last verified: 2018-07