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

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ClinicalTrials.gov Identifier: NCT02167113
Recruitment Status : Completed
First Posted : June 18, 2014
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Hologic, Inc.

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.

Condition or disease
Hepatitis B, Chronic

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Study Type : Observational
Actual Enrollment : 331 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : March 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : January 23, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
study population



Primary Outcome Measures :
  1. 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.


  2. 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.



Biospecimen Retention:   Samples With DNA
Plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167113


Locations
Show Show 90 study locations
Sponsors and Collaborators
Hologic, Inc.
Investigators
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Study Director: Christine Kuslich Hologic, Inc.
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Responsible Party: Hologic, Inc.
ClinicalTrials.gov Identifier: NCT02167113    
Other Study ID Numbers: V10434-HBVQPS-CSP-01
V10434-HBVQPS-CSP-01 ( Other Identifier: Hologic )
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic