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
- TERMINATED
- Sex
- All
- Target Recruitment
- 1708
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 D.C., District of Columbia, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of Miami, Schiff Center for Liver Disease
🇺🇸Miami, Florida, United States
Scroll for more (21 remaining)Banner University Medical Center Phoenix🇺🇸Phoenix, Arizona, United States