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

Hepatitis B, Chronic Clinical Trial

— HBVQuant  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167113
• Other study ID #: V10434-HBVQPS-CSP-01
• Secondary ID: V10434-HBVQPS-CS
• Status: Completed
• Start date: March 2014
• Est. completion date: January 23, 2018

Study information

• Verified date: July 2018
• Source: Hologic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: January 23, 2018
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  Germany,  Hungary,  Italy,  New Zealand,  Romania,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)