Clinical trial NCT02167113: Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B, Chronic
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-18
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: Week 48 (from start of therapy)
measure: 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).
timeFrame: Week 48 (from start of therapy)
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Health Good Samaritan
state: Arizona
city: Phoenix
country: United States
facility: Dignity Health - St. Joseph's Hospital
state: Arizona
city: Garden Grove
country: United States
facility: Advanced Rx Clinical Research
state: California
city: Lancaster
country: United States
facility: High Desert Gastroenterology
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: San Francisco
country: United States
facility: Kaiser Foundation Hospital
state: California
city: San Jose
country: United States
facility: San Jose Gastroenterology
state: California
city: Torrance
country: United States
facility: South Bay Gastroenterology Medical Group
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Miami
country: United States
facility: Schiff Center for Liver Disease
state: Florida
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia
state: Georgia
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Catonsville
country: United States
facility: Digestive Disease Associates, PA
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Newton
country: United States
facility: Newton-Wellesley Hospital
state: Massachusetts
city: Springfield
country: United States
facility: The Research Institute
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Newark
country: United States
facility: University of Medicine and Dentistry of New Jersey
state: New Jersey
city: Flushing
country: United States
facility: Sing Chan, MD
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Charlotte
country: United States
facility: Carolinas HealthCare System
state: North Carolina
city: Statesville
country: United States
facility: Piedmont HealthCare
state: North Carolina
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Healthcare Network
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Austin
country: United States
facility: Austin Center for Clinical Research
state: Texas
city: Houston
country: United States
facility: Kelsey Research Foundation
state: Texas
city: Houston
country: United States
facility: Liver Associates of Texas
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Kingswood
country: Australia
facility: Napean Hospital, Gastroenterology and Hepatology Department
state: New South Wales
city: Sydney
country: Australia
facility: Liverpool Hospital, Department of Gastroenterology
state: New South Wales
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Department of Gastroenterology
state: Victoria
city: PLeven
country: Bulgaria
facility: UMHAT Dr. Gerogi Stranski, Clinic of Gastroenterology
city: Sofia
country: Bulgaria
facility: UMHAT Aleksandrovska, Clinic of Gastroenterology
city: Sofia
country: Bulgaria
facility: UMHAT Sveti Ivan Rilski Clinic of Gastroenterology
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Vancouver,
country: Canada
facility: Lair Centre
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Vancouver
country: Canada
facility: GI Research Institute
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Berlin
country: Germany
facility: Leberzentrum am Checkpoint Fachärztegemeinschaft für innere Krankheiten
city: Berlin
country: Germany
facility: Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
city: Berlin
country: Germany
facility: Zentrum für Infektiologie Berlin Prenzlauer Berg
city: Essen
country: Germany
facility: Universitätsklinikum Essen Klinik für Gastroenterologie und Hepatologie
city: Hamburg
country: Germany
facility: ifi-Studien und Projekte GmbH An der Asklepios Klinik St. Georg, Haus L
city: Hamburg
country: Germany
facility: ifi-Studien und Projekte GmbH, An der Asklepios Klinik St. Georg
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim II. Medizinische Klinik
city: Budapest
country: Hungary
facility: Szent István és Szent László Kórház
city: Budapest
country: Hungary
facility: Budai Hepatollógiai Központ
city: Budapest
country: Hungary
facility: Szent János Kórház
city: Budapest
country: Hungary
facility: Budai Hepatollógiai Központ
city: Budapest
country: Hungary
facility: Szent János Kórház
city: Gyula
country: Hungary
facility: Pándy Kálmán Megyei Kórház
city: Salerno
country: Italy
facility: 'Ospdale Da Procida
city: Sassari
country: Italy
facility: 'Medicina Interna - Ospedale Civile
city: Sassari
country: Italy
facility: Medicina Interna - Ospedale Civile
city: Grafton
country: New Zealand
facility: Auckland Liver Research Unit
state: Auckland
city: Hamilton West
country: New Zealand
facility: Waikato Gastroenterology and Respiratory Research Office
state: Waikato
city: Newton
country: New Zealand
facility: Gastroenterology Research, Wellington Hospital
state: Wellington
city: Sector 1
country: Romania
facility: Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"
state: Bucuresti
city: Sector 2
country: Romania
facility: Institutul de Boli Infectioase "Prof. Dr. Matei Bals"
state: Bucuresti
city: Sector 2
country: Romania
facility: Institutul Clinic Fundeni, Bucuresti
state: Bucuresti
city: Sector 5
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti
state: Bucuresti
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sibiu
state: Jud. Sibiu
city: Timisoara
country: Romania
facility: Policlinica Algomed, Timisoara
state: Jud. Timis
city: Constanta
country: Romania
facility: Spitalul Clininc de Boli Infecţioase Constanţa
state: Judetul Constanta
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpaşa School of Medicine
state: Istanbul Province
city: Ankara
country: Turkey
facility: Ankara University School of Medicine
city: Ankara
country: Turkey
facility: Yıldırım Beyazıt University Atatürk Training and Research Hospital
city: Aydin
country: Turkey
facility: Adnan Menderes Üniversitesi
city: Bursa
country: Turkey
facility: Uludag University School of Medicine
city: Diyarbakir
country: Turkey
facility: Dicle University School of Medicine
city: Eskişehir
country: Turkey
facility: Osmangazi University School of Medicine
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul School of Medicine
city: Izmir
country: Turkey
facility: Dokuz Eylül University School of Medicine
city: Kocaeli
country: Turkey
facility: Kocaeli University School of Medicine
city: Konya
country: Turkey
facility: Selçuk University School of Medicine
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University School of Medicine
city: Trabzon
country: Turkey
facility: Karadeniz Technical University School of Medicine
Study officials:
affiliation: Hologic, Inc.
name: Christine Kuslich
role: STUDY_DIRECTOR
References: