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

NCT ID: NCT03692897

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1708 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-11

Study Completion Date

2025-09-10

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis B Hepatitis Liver Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Target PharmaSolutions, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Banner University Medical Center Phoenix

Phoenix, Arizona, United States

Site Status

Asian Pacific Liver Center at Coalition of Inclusive Medicine

Los Angeles, California, United States

Site Status

California Liver Research Institute

Pasadena, California, United States

Site Status

Stanford University

Redwood City, California, United States

Site Status

UC Davis GI/Hepatology Clinical Trials Unit

Sacramento, California, United States

Site Status

Silicon Valley Research Institute

San Jose, California, United States

Site Status

Yale University Digestive Diseases

New Haven, Connecticut, United States

Site Status

Medstar Georgetown University Hospital

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

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

University of Miami, Schiff Center for Liver Disease

Miami, Florida, United States

Site Status

Consultative Gastroenterology

Atlanta, Georgia, United States

Site Status

Atlanta Gastroenterology

Atlanta, Georgia, United States

Site Status

Rush Universtiy Medical Center

Chicago, Illinois, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Mercy Medical Center

Baltimore, Maryland, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Minnesota Gastroenterology, P.A.

Plymouth, Minnesota, United States

Site Status

Rutgers, Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status

Dreamwork Medical, PLLC

Flushing, New York, United States

Site Status

Northwell Health Center for Liver Diseases and Transplantation

Manhasset, New York, United States

Site Status

NYU Langone Health

New York, New York, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

UNC Liver Center

Chapel Hill, North Carolina, United States

Site Status

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Digestive and Liver Disease Specialist

Norfolk, Virginia, United States

Site Status

Bon Secours Liver Institute of Richmond

Richmond, Virginia, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Swedish Organ Transplant and Liver Center

Seattle, Washington, United States

Site Status

University of Washington/Harborview Medical Center

Seattle, Washington, United States

Site Status

UHN Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 34059991 (View on PubMed)

Other Identifiers

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TARGET-HBV

Identifier Type: -

Identifier Source: org_study_id

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