Hepatitis B, ChronicHBVQuantNCT02167113
Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay
An observational study of Hepatitis B, Chronic, run by Hologic, Inc. at 90 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- How many people
- 331 participants
- Where
- 90 sitesin 10 countries
- Study dates
- Mar 2014to 23 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Treatment naïve men and women ≥18 years of age with chronic HBV infection initiating entecavir or tenofovir treatment.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
90 sites in 10 countries.
90 sites in 10 countries
United States38 sites
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309
Austin Center for Clinical Research
Austin, Texas, 78756
Mercy Medical Center
Baltimore, Maryland, 21202
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Digestive Disease Associates, PA
Catonsville, Maryland, 21228
Carolinas HealthCare System
Charlotte, North Carolina, 28204
Henry Ford Health System
Detroit, Michigan, 48202
Sing Chan, MD
Flushing, New York, 11355
Advanced Rx Clinical Research
Garden Grove, California, 92843
Kelsey Research Foundation
Houston, Texas, 77005
Liver Associates of Texas
Houston, Texas, 77030
High Desert Gastroenterology
Lancaster, California, 93534
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53705
North Shore University Hospital
Manhasset, New York, 11030
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060
Schiff Center for Liver Disease
Miami, Florida, 33136
Nashville Medical Research Institute
Nashville, Tennessee, 37205
Yale University School of Medicine
New Haven, Connecticut, 06520
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, 07103
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Stanford University Medical Center
Palo Alto, California, 94304
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
Banner Health Good Samaritan
Phoenix, Arizona, 85006
Dignity Health - St. Joseph's Hospital
Phoenix, Arizona, 85013
Rhode Island Hospital
Providence, Rhode Island, 02903
Inland Empire Liver Foundation
Rialto, California, 92377
University of Utah School of Medicine
Salt Lake City, Utah, 84132
Kaiser Permanente
San Diego, California, 92154
Kaiser Foundation Hospital
San Francisco, California, 94115
San Jose Gastroenterology
San Jose, California, 95116
Harborview Medical Center
Seattle, Washington, 98104
The Research Institute
Springfield, Massachusetts, 01105-1406
Piedmont HealthCare
Statesville, North Carolina, 28677
South Bay Gastroenterology Medical Group
Torrance, California, 90505
Turkey (Türkiye)13 sites
Ankara University School of Medicine
Ankara, 06620
Yıldırım Beyazıt University Atatürk Training and Research Hospital
Ankara
Adnan Menderes Üniversitesi
Aydin, 09010
Uludag University School of Medicine
Bursa, 16059
Dicle University School of Medicine
Diyarbakır
Osmangazi University School of Medicine
Eskişehir, 26040
Istanbul University Cerrahpaşa School of Medicine
Istanbul, Istanbul, 34098
Istanbul University Istanbul School of Medicine
Istanbul, 34093
Dokuz Eylül University School of Medicine
Izmir, 35210
Kocaeli University School of Medicine
Kocaeli
Selçuk University School of Medicine
Konya, 42131
Ondokuz Mayıs University School of Medicine
Samsun, 55139
Karadeniz Technical University School of Medicine
Trabzon, 61080
Germany8 sites
Leberzentrum am Checkpoint Fachärztegemeinschaft für innere Krankheiten
Berlin, 10969
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
Berlin, 13353
Zentrum für Infektiologie Berlin Prenzlauer Berg
Berlin, 13353
Universitätsklinikum Essen Klinik für Gastroenterologie und Hepatologie
Essen, 45122
ifi-Studien und Projekte GmbH An der Asklepios Klinik St. Georg, Haus L
Hamburg, 20099
ifi-Studien und Projekte GmbH, An der Asklepios Klinik St. Georg
Hamburg, 20099
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Universitätsmedizin Mannheim II. Medizinische Klinik
Mannheim, 68167
Romania7 sites
Spitalul Clininc de Boli Infecţioase Constanţa
Constanța, Constanța County
Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"
Sector 1, Bucharest, 010825
Institutul de Boli Infectioase "Prof. Dr. Matei Bals"
Sector 2, Bucharest, 021105
Institutul Clinic Fundeni, Bucuresti
Sector 2, Bucharest
Spitalul Universitar de Urgenta Bucuresti
Sector 5, Bucharest
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, Jud. Sibiu
Policlinica Algomed, Timisoara
Timișoara, Jud. Timis
Canada6 sites
Foothills Medical Centre
Calgary, Alberta, T2N 4Z6
London Health Sciences Centre
London, Ontario, N6A 5A5
Toronto Liver Centre
Toronto, Ontario, M6H 3M1
Lair Centre
Vancouver, British Columbia, V5Z 1H2
University of British Columbia
Vancouver, British Columbia, V5Z 1M9
GI Research Institute
Vancouver, British Columbia, V6Z 2K5
Hungary6 sites
Szent István és Szent László Kórház
Budapest, 1097
Budai Hepatollógiai Központ
Budapest, 1111
Szent János Kórház
Budapest, 1125
Budai Hepatollógiai Központ
Budapest
Szent János Kórház
Budapest
Pándy Kálmán Megyei Kórház
Gyula, 5700
Australia3 sites
St Vincent's Hospital Department of Gastroenterology
Fitzroy, Victoria, 3065
Napean Hospital, Gastroenterology and Hepatology Department
Kingswood, New South Wales, 2747
Liverpool Hospital, Department of Gastroenterology
Sydney, New South Wales, 2170
Bulgaria3 sites
UMHAT Dr. Gerogi Stranski, Clinic of Gastroenterology
Pleven, 5800
UMHAT Aleksandrovska, Clinic of Gastroenterology
Sofia, 1431
UMHAT Sveti Ivan Rilski Clinic of Gastroenterology
Sofia, 1431
Italy3 sites
'Ospdale Da Procida
Salerno
'Medicina Interna - Ospedale Civile
Sassari
Medicina Interna - Ospedale Civile
Sassari
New Zealand3 sites
Auckland Liver Research Unit
Grafton, Auckland, 1142
Waikato Gastroenterology and Respiratory Research Office
Hamilton West, Waikato Region, 3024
Gastroenterology Research, Wellington Hospital
Newton, Wellington Region, 6021
About this study
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
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.
- Conditions
- Hepatitis B, Chronic
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study population | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 48 (from start of therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2016
- Study completion23 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Kuslich, Study director, Hologic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167113
- Sponsor's protocol ID
- V10434-HBVQPS-CSP-01
- Other IDs
- V10434-HBVQPS-CSP-01
- Acronym
- HBVQuant
- Status last verified
- Jul 2018
- First submitted
- 12 Jun 2014
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02167113
- Acronym / sponsor ID
- HBVQuant / V10434-HBVQPS-CSP-01
- Conditions
- Hepatitis B, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- 23 Jan 2018 (actual)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study population | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment naïve men and women ≥18 years of age with chronic HBV infection initiating entecavir or tenofovir treatment.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- Subject is in one of the following patient populations:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Kuslich study director
Hologic, Inc.
90 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, Chronic, run by Hologic, Inc. at 90 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites in United States, Turkey (Türkiye), Germany, Romania, Canada and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: Week 48 (from start of therapy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.