Clinical trial NCT03692897: An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection
Official title: An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis B
Hepatitis
Liver Diseases
Lead sponsor: Target PharmaSolutions, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-02
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility criteria: Inclusion

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

Primary outcomes:
measure: Natural history of CHB: Characteristics of CHB infection
timeFrame: Up to 10 years
measure: Natural history of CHB: Participant demographics
timeFrame: Up to 10 years
measure: Natural history of CHB: Treatment use
timeFrame: Up to 10 years
measure: Natural history of CHB: Treatment response
timeFrame: Up to 10 years
measure: Time point of clinical response
timeFrame: Every 6 months for 10 years
measure: Natural history of CHB: Disease progression
timeFrame: Up to 10 years
measure: Adverse event frequency and severity
timeFrame: Up to 10 years
Secondary outcomes:
measure: Reasons for treatment discontinuation
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix
state: Arizona
city: Los Angeles
country: United States
facility: Asian Pacific Liver Center at Coalition of Inclusive Medicine
state: California
city: Pasadena
country: United States
facility: California Liver Research Institute
state: California
city: Redwood City
country: United States
facility: Stanford University
state: California
city: Sacramento
country: United States
facility: UC Davis GI/Hepatology Clinical Trials Unit
state: California
city: San Jose
country: United States
facility: Silicon Valley Research Institute
state: California
city: New Haven
country: United States
facility: Yale University Digestive Diseases
state: Connecticut
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami, Schiff Center for Liver Disease
state: Florida
city: Atlanta
country: United States
facility: Consultative Gastroenterology
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Gastroenterology
state: Georgia
city: Chicago
country: United States
facility: Rush Universtiy Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Plymouth
country: United States
facility: Minnesota Gastroenterology, P.A.
state: Minnesota
city: New Brunswick
country: United States
facility: Rutgers, Robert Wood Johnson Medical School
state: New Jersey
city: Flushing
country: United States
facility: Dreamwork Medical, PLLC
state: New York
city: Manhasset
country: United States
facility: Northwell Health Center for Liver Diseases and Transplantation
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Liver Center
state: North Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialist
state: Virginia
city: Richmond
country: United States
facility: Bon Secours Liver Institute of Richmond
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Swedish Organ Transplant and Liver Center
state: Washington
city: Seattle
country: United States
facility: University of Washington/Harborview Medical Center
state: Washington
city: Toronto
country: Canada
facility: UHN Toronto General Hospital
state: Ontario
Study officials:
References:
citation: 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.