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

NCT03692897 | Terminated

• 1 other identifier: TARGET-HBV
• Study Type: observational
• Target: 1,708
• Locations: 2 countries
• Sites: 31

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.

Conditions

Hepatitis B; Hepatitis; Liver Diseases

Outcome Measures

Primary Outcomes (7)

• 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

• Adverse event frequency and severity

  Up to 10 years

Secondary Outcomes (1)

• Reasons for treatment discontinuation

  Up to 10 years

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Inability to provide written informed consent
• Known history of Human Immunodeficiency Virus (HIV)
• History of liver transplantation

Sponsors & Collaborators

• Target PharmaSolutions, Inc.: lead

Study Sites (31)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Asian Pacific Liver Center at Coalition of Inclusive Medicine

Los Angeles, California, 90020, United States

Location

California Liver Research Institute

Pasadena, California, 91105, United States

Location

Stanford University

Redwood City, California, 94063, United States

Location

UC Davis GI/Hepatology Clinical Trials Unit

Sacramento, California, 95817, United States

Location

Silicon Valley Research Institute

San Jose, California, 95128, United States

Location

Yale University Digestive Diseases

New Haven, Connecticut, 06520, United States

Location

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

University of Florida

Gainesville, Florida, 32610-0272, United States

Location

University of Miami, Schiff Center for Liver Disease

Miami, Florida, 33136, United States

Location

Consultative Gastroenterology

Atlanta, Georgia, 30308, United States

Location

Atlanta Gastroenterology

Atlanta, Georgia, 30342, United States

Location

Rush Universtiy Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Minnesota Gastroenterology, P.A.

Plymouth, Minnesota, 55446, United States

Location

Rutgers, Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Dreamwork Medical, PLLC

Flushing, New York, 11354, United States

Location

Northwell Health Center for Liver Diseases and Transplantation

Manhasset, New York, 11030, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

UNC Liver Center

Chapel Hill, North Carolina, 27599, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Digestive and Liver Disease Specialist

Norfolk, Virginia, 23502, United States

Location

Bon Secours Liver Institute of Richmond

Richmond, Virginia, 23226, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Swedish Organ Transplant and Liver Center

Seattle, Washington, 98104, United States

Location

University of Washington/Harborview Medical Center

Seattle, Washington, 98104, United States

Location

UHN Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

• Bernstein DE, Trinh HN, Schiff ER, Smith CI, Mospan AR, Zink RC, Fried MW, Lok AS. Safety and Effectiveness of Tenofovir Alafenamide in Usual Clinical Practice Confirms Results of Clinical Trials: TARGET-HBV. Dig Dis Sci. 2022 Jun;67(6):2637-2645. doi: 10.1007/s10620-021-07033-y. Epub 2021 May 31.

  PMID: 34059991 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Patients enrolled in TARGET-HBV may be invited to participate in the Biorepository Bank (BSB). Blood samples for biomarker and DNA assays will be collected on a voluntary basis and participation in this project will not affect participation in the main study. These samples will be shipped to a central repository for storage to use in future studies. Samples stored at the biorepository will be identified only with the participant's unique study ID number and the date the sample was obtained. The link between the participant's study ID number and their name will be available only at the site where the samples were obtained.

MeSH Terms

Conditions

Hepatitis B; Hepatitis; Liver Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: October 2, 2018
• Study Start: October 11, 2018
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (30); CA (1)