Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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).
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).
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
Sex
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
1/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/01/2018
Sample size
Target
Accrual to date
Final
331
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02167113