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

November 13, 2023 updated by: Target PharmaSolutions, Inc.
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • UHN Toronto General Hospital
        • Contact:
        • Principal Investigator:
          • David KH Wong, MD
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Terminated
        • Banner University Medical Center Phoenix
    • California
      • Los Angeles, California, United States, 90020
        • Recruiting
        • Asian Pacific Liver Center at Coalition of Inclusive Medicine
        • Contact:
        • Principal Investigator:
          • Ho Bae, M.D.
      • Pasadena, California, United States, 91105
        • Terminated
        • California Liver Research Institute
      • Redwood City, California, United States, 94063
        • Active, not recruiting
        • Stanford University
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis GI/Hepatology Clinical Trials Unit
        • Contact:
        • Principal Investigator:
          • Erik Chak, MD
      • San Jose, California, United States, 95128
        • Terminated
        • Silicon Valley Research Institute
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Terminated
        • Yale University Digestive Diseases
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Active, not recruiting
        • MedStar Georgetown University Hospital
    • Florida
      • Gainesville, Florida, United States, 32610-0272
        • Terminated
        • University of Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami, Schiff Center for Liver Disease
        • Contact:
        • Principal Investigator:
          • Eugene Schiff, MD
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Terminated
        • Consultative Gastroenterology
      • Atlanta, Georgia, United States, 30342
        • Terminated
        • Atlanta Gastroenterology
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Terminated
        • University of Chicago
      • Chicago, Illinois, United States, 60612
        • Active, not recruiting
        • Rush Universtiy Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Recruiting
        • Mercy Medical Center
        • Principal Investigator:
          • Paul Thuluvath, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Anna Lok, MD
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Terminated
        • Minnesota Gastroenterology, P.A.
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Terminated
        • Rutgers, Robert Wood Johnson Medical School
    • New York
      • Flushing, New York, United States, 11354
        • Terminated
        • Dreamwork Medical, PLLC
      • Manhasset, New York, United States, 11030
        • Terminated
        • Northwell Health Center for Liver Diseases and Transplantation
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Contact:
        • Principal Investigator:
          • Viviana Figueroa-Diaz, MD
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:
        • Principal Investigator:
          • Elizabeth Verna, MD
      • New York, New York, United States, 10021
        • Active, not recruiting
        • Weill Cornell Medical College
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Terminated
        • UNC Liver Center
    • Texas
      • Dallas, Texas, United States, 75390
        • Terminated
        • UT Southwestern Medical Center
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Terminated
        • Digestive and Liver Disease Specialist
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
        • Principal Investigator:
          • Hannah Lee, MD
      • Richmond, Virginia, United States, 23226
        • Terminated
        • Bon Secours Liver Institute of Richmond
    • Washington
      • Seattle, Washington, United States, 98104
        • Terminated
        • Swedish Organ Transplant and Liver Center
      • Seattle, Washington, United States, 98104
        • Terminated
        • University of Washington/Harborview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Reasons for treatment discontinuation
Time Frame: Up to 10 years
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Target PharmaSolutions, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2018

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

September 4, 2018

First Submitted That Met QC Criteria

October 1, 2018

First Posted (Actual)

October 2, 2018

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TARGET-HBV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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