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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03692897
• Other study ID #: TARGET-HBV
• Status: Recruiting
• Start date: October 11, 2018
• Est. completion date: January 2026

Study information

• Verified date: November 2023
• Source: Target PharmaSolutions, Inc.
• Contact: Stephanie Harrison
• Phone: 919-930-2792
• Email: sharrison[@]targetrwe.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	UHN Toronto General Hospital	Toronto	Ontario
United States	University of Michigan	Ann Arbor	Michigan
United States	Atlanta Gastroenterology	Atlanta	Georgia
United States	Consultative Gastroenterology	Atlanta	Georgia
United States	Mercy Medical Center	Baltimore	Maryland
United States	UNC Liver Center	Chapel Hill	North Carolina
United States	Rush Universtiy Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Dreamwork Medical, PLLC	Flushing	New York
United States	University of Florida	Gainesville	Florida
United States	Asian Pacific Liver Center at Coalition of Inclusive Medicine	Los Angeles	California
United States	Northwell Health Center for Liver Diseases and Transplantation	Manhasset	New York
United States	University of Miami, Schiff Center for Liver Disease	Miami	Florida
United States	Rutgers, Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Yale University Digestive Diseases	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	NYU Langone Health	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Digestive and Liver Disease Specialist	Norfolk	Virginia
United States	California Liver Research Institute	Pasadena	California
United States	Banner University Medical Center Phoenix	Phoenix	Arizona
United States	Minnesota Gastroenterology, P.A.	Plymouth	Minnesota
United States	Stanford University	Redwood City	California
United States	Bon Secours Liver Institute of Richmond	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	UC Davis GI/Hepatology Clinical Trials Unit	Sacramento	California
United States	Silicon Valley Research Institute	San Jose	California
United States	Swedish Organ Transplant and Liver Center	Seattle	Washington
United States	University of Washington/Harborview Medical Center	Seattle	Washington
United States	Medstar Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Target PharmaSolutions, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Natural history of CHB: Characteristics of CHB infection		Up to 10 years
Primary	Natural history of CHB: Participant demographics		Up to 10 years
Primary	Natural history of CHB: Treatment use		Up to 10 years
Primary	Natural history of CHB: Treatment response		Up to 10 years
Primary	Time point of clinical response		Every 6 months for 10 years
Primary	Natural history of CHB: Disease progression		Up to 10 years
Primary	Adverse event frequency and severity		Up to 10 years
Secondary	Reasons for treatment discontinuation		Up to 10 years