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

Completed

Conditions studied: Hepatitis B, Chronic

In brief

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.

Key facts

Study ID

NCT02167113

Run by

Hologic, Inc.

People needed

331

Starts

2014-03-01

Expected to finish

2018-01-23

Last updated by the study team

2018-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Dignity Health - St. Joseph's Hospital — Phoenix, Arizona, United States
• Advanced Rx Clinical Research — Garden Grove, California, United States
• High Desert Gastroenterology — Lancaster, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Inland Empire Liver Foundation — Rialto, California, United States
• Kaiser Permanente — San Diego, California, United States
• Kaiser Foundation Hospital — San Francisco, California, United States
• San Jose Gastroenterology — San Jose, California, United States
• South Bay Gastroenterology Medical Group — Torrance, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Schiff Center for Liver Disease — Miami, Florida, United States
• Digestive Healthcare of Georgia — Atlanta, Georgia, United States
• Gastrointestinal Specialists of Georgia — Marietta, Georgia, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• Digestive Disease Associates, PA — Catonsville, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Newton-Wellesley Hospital — Newton, Massachusetts, United States
• The Research Institute — Springfield, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• University of Medicine and Dentistry of New Jersey — Newark, New Jersey, United States
• Sing Chan, MD — Flushing, New York, United States
• North Shore University Hospital — Manhasset, New York, United States
• Carolinas HealthCare System — Charlotte, North Carolina, United States
• Banner Health Good Samaritan — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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