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

Target PharmaSolutions, Inc.1,708 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,708

Conditions

Hepatitis B Hepatitis Liver Diseases

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (31)

Banner University Medical Center Phoenix

Phoenix, Arizona, United States

Asian Pacific Liver Center at Coalition of Inclusive Medicine

Los Angeles, California, United States

California Liver Research Institute

Pasadena, California, United States

Stanford University

Redwood City, California, United States

UC Davis GI/Hepatology Clinical Trials Unit

Sacramento, California, United States

Outcomes

Primary Outcomes

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 Outcomes

Reasons for treatment discontinuation

Time frame: Up to 10 years