Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hologic, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay