An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection
- Conditions
- Liver DiseasesHepatitisHepatitis B
- Registration Number
- NCT03692897
- Lead Sponsor
- Target PharmaSolutions, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Natural history of CHB: Participant demographics Up to 10 years Natural history of CHB: Characteristics of CHB infection Up to 10 years Natural history of CHB: Treatment use Up to 10 years Time point of clinical response Every 6 months for 10 years Adverse event frequency and severity Up to 10 years Natural history of CHB: Treatment response Up to 10 years Natural history of CHB: Disease progression Up to 10 years
- Secondary Outcome Measures
Name Time Method Reasons for treatment discontinuation Up to 10 years
Trial Locations
- Locations (31)
Banner University Medical Center Phoenix
🇺🇸Phoenix, Arizona, United States
Asian Pacific Liver Center at Coalition of Inclusive Medicine
🇺🇸Los Angeles, California, United States
California Liver Research Institute
🇺🇸Pasadena, California, United States
Stanford University
🇺🇸Redwood City, California, United States
UC Davis GI/Hepatology Clinical Trials Unit
🇺🇸Sacramento, California, United States
Silicon Valley Research Institute
🇺🇸San Jose, California, United States
Yale University Digestive Diseases
🇺🇸New Haven, Connecticut, United States
Medstar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of Miami, Schiff Center for Liver Disease
🇺🇸Miami, Florida, United States
Consultative Gastroenterology
🇺🇸Atlanta, Georgia, United States
Atlanta Gastroenterology
🇺🇸Atlanta, Georgia, United States
Rush Universtiy Medical Center
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Minnesota Gastroenterology, P.A.
🇺🇸Plymouth, Minnesota, United States
Rutgers, Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Dreamwork Medical, PLLC
🇺🇸Flushing, New York, United States
Northwell Health Center for Liver Diseases and Transplantation
🇺🇸Manhasset, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
UNC Liver Center
🇺🇸Chapel Hill, North Carolina, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Digestive and Liver Disease Specialist
🇺🇸Norfolk, Virginia, United States
Bon Secours Liver Institute of Richmond
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Swedish Organ Transplant and Liver Center
🇺🇸Seattle, Washington, United States
University of Washington/Harborview Medical Center
🇺🇸Seattle, Washington, United States
UHN Toronto General Hospital
🇨🇦Toronto, Ontario, Canada