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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02167113




Registration number
NCT02167113
Ethics application status
Date submitted
12/06/2014
Date registered
18/06/2014
Date last updated
1/08/2018

Titles & IDs
Public title
Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay
Scientific 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
Secondary ID [1] 0 0
V10434-HBVQPS-CSP-01
Secondary ID [2] 0 0
V10434-HBVQPS-CSP-01
Universal Trial Number (UTN)
Trial acronym
HBVQuant
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
study population -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Week 48 (from start of therapy)
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Week 48 (from start of therapy)

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Napean Hospital, Gastroenterology and Hepatology Department - Kingswood
Recruitment hospital [2] 0 0
Liverpool Hospital, Department of Gastroenterology - Sydney
Recruitment hospital [3] 0 0
St Vincent's Hospital Department of Gastroenterology - Fitzroy
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
2170 - Sydney
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Rhode Island
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Bulgaria
State/province [21] 0 0
PLeven
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Sofia
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
British Columbia
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Germany
State/province [26] 0 0
Berlin
Country [27] 0 0
Germany
State/province [27] 0 0
Essen
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Germany
State/province [29] 0 0
Mainz
Country [30] 0 0
Germany
State/province [30] 0 0
Mannheim
Country [31] 0 0
Hungary
State/province [31] 0 0
Budapest
Country [32] 0 0
Hungary
State/province [32] 0 0
Gyula
Country [33] 0 0
Italy
State/province [33] 0 0
Salerno
Country [34] 0 0
Italy
State/province [34] 0 0
Sassari
Country [35] 0 0
New Zealand
State/province [35] 0 0
Auckland
Country [36] 0 0
New Zealand
State/province [36] 0 0
Waikato
Country [37] 0 0
New Zealand
State/province [37] 0 0
Wellington
Country [38] 0 0
Romania
State/province [38] 0 0
Bucuresti
Country [39] 0 0
Romania
State/province [39] 0 0
Jud. Sibiu
Country [40] 0 0
Romania
State/province [40] 0 0
Jud. Timis
Country [41] 0 0
Romania
State/province [41] 0 0
Judetul Constanta
Country [42] 0 0
Turkey
State/province [42] 0 0
Istanbul Province
Country [43] 0 0
Turkey
State/province [43] 0 0
Ankara
Country [44] 0 0
Turkey
State/province [44] 0 0
Aydin
Country [45] 0 0
Turkey
State/province [45] 0 0
Bursa
Country [46] 0 0
Turkey
State/province [46] 0 0
Diyarbakir
Country [47] 0 0
Turkey
State/province [47] 0 0
Eskisehir
Country [48] 0 0
Turkey
State/province [48] 0 0
Istanbul
Country [49] 0 0
Turkey
State/province [49] 0 0
Izmir
Country [50] 0 0
Turkey
State/province [50] 0 0
Kocaeli
Country [51] 0 0
Turkey
State/province [51] 0 0
Konya
Country [52] 0 0
Turkey
State/province [52] 0 0
Samsun
Country [53] 0 0
Turkey
State/province [53] 0 0
Trabzon

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hologic, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT02167113
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christine Kuslich
Address 0 0
Hologic, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications