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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03692897

Enrollment

1708

Registered

2018-10-02

Start date

2018-10-11

Completion date

2025-09-10

Last updated

2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis, Hepatitis B, Liver Diseases

Brief summary

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.

Interventions

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

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

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Adverse event frequency and severity	Up to 10 years
Natural history of CHB: Characteristics of CHB infection	Up to 10 years
Natural history of CHB: Participant demographics	Up to 10 years
Natural history of CHB: Treatment use	Up to 10 years
Natural history of CHB: Treatment response	Up to 10 years
Time point of clinical response	Every 6 months for 10 years
Natural history of CHB: Disease progression	Up to 10 years

Secondary

Measure	Time frame
Reasons for treatment discontinuation	Up to 10 years

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026