An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection

Target PharmaSolutions

Status: Terminated

Conditions: Hepatitis; Hepatitis B; Liver Diseases

Treatments: Other: All approved therapies for the treatment of Chronic Hepatitis B (CHB)

Study type: Observational

Funder types: Industry

Identifiers

NCT03692897

TARGET-HBV

Details and patient eligibility

About

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.

Enrollment: 1,708 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion

1. Male or female patients, age ≥18 years
2. Being managed for chronic hepatitis B (CHB), including patients who have achieved functional cure and patients with concurrent delta hepatitis

Exclusion

1. Inability to provide written informed consent
2. Known history of Human Immunodeficiency Virus (HIV)
3. History of liver transplantation