Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

Hepatitis B Hepatitis Liver Diseases Hepatitis A Hepatitis B, Chronic All approved therapies for the treatment of Chronic Hepatitis B (CHB)

Eligibility

For people ages 18 years and up

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

  • UC Davis GI/Hepatology Clinical Trials Unit
    Sacramento California 95817 United States
  • Silicon Valley Research Institute
    San Jose California 95128 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Target PharmaSolutions, Inc.
Links
Sign up for this study
ID
NCT03692897
Study Type
Observational
Participants
Expecting 5000 study participants
Last Updated