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Study Closure
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| All approved therapies for the treatment of Chronic Hepatitis B (CHB) | Other | All approved therapies for the treatment of Chronic Hepatitis B (CHB). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for treatment discontinuation | Up to 10 years |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center Phoenix | Phoenix | Arizona | 85006 | United States | ||
| Asian Pacific Liver Center at Coalition of Inclusive Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34059991 | Derived | 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. |
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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.
| Los Angeles |
| California |
| 90020 |
| United States |
| California Liver Research Institute | Pasadena | California | 91105 | United States |
| Stanford University | Redwood City | California | 94063 | United States |
| UC Davis GI/Hepatology Clinical Trials Unit | Sacramento | California | 95817 | United States |
| Silicon Valley Research Institute | San Jose | California | 95128 | United States |
| Yale University Digestive Diseases | New Haven | Connecticut | 06520 | United States |
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| University of Florida | Gainesville | Florida | 32610-0272 | United States |
| University of Miami, Schiff Center for Liver Disease | Miami | Florida | 33136 | United States |
| Consultative Gastroenterology | Atlanta | Georgia | 30308 | United States |
| Atlanta Gastroenterology | Atlanta | Georgia | 30342 | United States |
| Rush Universtiy Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Minnesota Gastroenterology, P.A. | Plymouth | Minnesota | 55446 | United States |
| Rutgers, Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
| Dreamwork Medical, PLLC | Flushing | New York | 11354 | United States |
| Northwell Health Center for Liver Diseases and Transplantation | Manhasset | New York | 11030 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| UNC Liver Center | Chapel Hill | North Carolina | 27599 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Digestive and Liver Disease Specialist | Norfolk | Virginia | 23502 | United States |
| Bon Secours Liver Institute of Richmond | Richmond | Virginia | 23226 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Swedish Organ Transplant and Liver Center | Seattle | Washington | 98104 | United States |
| University of Washington/Harborview Medical Center | Seattle | Washington | 98104 | United States |
| UHN Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D004066 | Digestive System Diseases |
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