An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
The TARGET-HBV study engages an observational research design to conduct a comprehensive review of outcomes for patients with CHB infection. The initial phase of the study that enrolled patients treated with tenofovir alafenamide (TAF) was successfully completed. The current protocol (Amendment 1) describes the second phase of the study that will engage research activities for patients being managed for CHB in usual clinical practice in the US and Canada. The study addresses important clinical questions regarding the management of CHB by collecting and analyzing data from patients at academic and community medical centers. TARGET-HBV creates a robust database of real-world data regarding the natural history, management, and health outcomes related to antiviral treatments used in clinical practice.
Condition or disease
Hepatitis BHepatitisLiver Diseases
Other: All approved therapies for the treatment of Chronic Hepatitis B (CHB)
Natural history of CHB: Characteristics of CHB infection [ Time Frame: Up to 10 years ]
Natural history of CHB: Participant demographics [ Time Frame: Up to 10 years ]
Natural history of CHB: Treatment use [ Time Frame: Up to 10 years ]
Natural history of CHB: Treatment response [ Time Frame: Up to 10 years ]
Time point of clinical response [ Time Frame: Every 6 months for 10 years ]
Natural history of CHB: Disease progression [ Time Frame: Up to 10 years ]
Adverse event frequency and severity [ Time Frame: Up to 10 years ]
Secondary Outcome Measures :
Reasons for treatment discontinuation [ Time Frame: Up to 10 years ]
Biospecimen Retention: Samples With DNA
Patients enrolled in TARGET-HBV may be invited to participate in the Biorepository Bank (BSB). Blood samples for biomarker and DNA assays will be collected on a voluntary basis and participation in this project will not affect participation in the main study. These samples will be shipped to a central repository for storage to use in future studies. Samples stored at the biorepository will be identified only with the participant's unique study ID number and the date the sample was obtained. The link between the participant's study ID number and their name will be available only at the site where the samples were obtained.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Up to 5,000 adult Chronic Hepatitis B (CHB) patients in the US and Canada; the first 500 patients enrolled were patients in the US with a medical history of tenofovir alafenamide (TAF) use for the treatment of chronic HBV.
Male or female patients, age ≥18 years
Being managed for chronic hepatitis B (CHB), including patients who have achieved functional cure and patients with concurrent delta hepatitis
Inability to provide written informed consent
Known history of Human Immunodeficiency Virus (HIV)