HCV-TARGET- Hepatitis C Therapeutic Registry and Research Network

Hepatitis C Clinical Trial

Official title:

HCV-TARGET: Hepatitis C Therapeutic Registry and Research Network - A Longitudinal, Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474811
• Other study ID #: 11-1991
• Status: Completed
• Start date: November 2011
• Est. completion date: September 9, 2022

Study information

• Verified date: February 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary purpose of the HCV-TARGET study is to establish a nationwide registry of patients undergoing treatment with antiviral therapies for chronic hepatitis C (HCV) at both academic and community practices.

Description:

HCV-TARGET is a longitudinal, observational study that will create a carefully maintained research registry of HCV patients treated with antiviral therapies designed to rapidly inform strategies for better management of populations underrepresented in clinical trials, identify and remediate educational gaps relative to treatment guidelines and adverse event management in order to optimize rates of sustained virological response (SVR), and serve as the core resource for important collaborative translational studies utilizing biospecimens and clinical data from diverse patient populations.

HCV-TARGET is a cooperative academic consortium of principal investigators from Clinical and Translational Award (CTSA)-funded academic institutions and community-based sites affiliated with the academic sites in geographic proximity. The Clinical Coordinating Center (CCC) resides at the University of Florida and the Data Coordinating Center (DCC) resides at the University of North Carolina at Chapel Hill.

The HCV-TARGET registry will characterize the population of chronic hepatitis C (HCV) patients who are being treated with antiviral therapies at academic and community sites. Patient characteristics such as age, race, ethnicity, comorbidity, and disease and treatment status will be examined.

HCV-TARGET will also:

1. Provide baseline and treatment response data that will be used to pre-identify candidates for enrollment in future clinical trials. HCV-TARGET will also develop a well-characterized cohort of protease inhibitor treatment failures to be considered for future trials.

2. Establish and maintain data, a specimen bank and other resources for ancillary studies of the pathogenesis, diagnosis, natural history and treatment of HCV infection.

This study will investigate various aspects of treatment response to regimens containing direct-acting antiviral agents for the treatment of chronic hepatitis C, including the following:

• Patients underrepresented in clinical trials of approved antiviral therapies(including African-Americans, patients with cirrhosis, and patients that are considered null responders to treatment.)

• Treatment persistence

• Virological breakthrough

• Impact of viral load measurement on treatment efficacy

• Adverse Event Management and Surveillance.

The secondary aims for this study will investigate the following:

• Sustained virological response (SVR) rates and safety in special populations.

• Surveillance of drug-drug interactions.

• Treatment and management adherence.

• Pretreatment Education in HCV patient population.

• Use of specialty pharmacy for hepatitis C therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13559
• Est. completion date: September 9, 2022
• Est. primary completion date: September 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients (age 18 or older) being treated with antiviral HCV treatment regimens that contain telaprevir or boceprevir.

Exclusion Criteria:

• Inability to provide written informed consent.

• Currently participating in another clinical trial of hepatitis C therapeutics. Studies comparing HCV RNA assays are not considered exclusionary.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Locations

Country	Name	City	State
Canada	Liver Clinic, Toronto Western Hospital, UHN	Toronto	Ontario
Germany	RWTH University Hospital	Aachen
Germany	J. W. Goethe University Hospital	Frankfurt
Germany	Hanover Medical School	Hanover
Puerto Rico	Fundacion de investigacion de Diego	San Juan
United States	University of Michigan	Ann Arbor	Michigan
United States	Metropolitan Liver Diseases and Gastroenterology	Annandale	Virginia
United States	Asheville Gastroenterology Assoc	Asheville	North Carolina
United States	Atlanta Medical Center	Atlanta	Georgia
United States	Emory University	Atlanta	Georgia
United States	Austin Hepatitis Center	Austin	Texas
United States	MetaClin Research, Inc	Austin	Texas
United States	Hudson River Healthcare	Beacon	New York
United States	Harvard University/ Beth Deaconess Medical Center	Boston	Massachusetts
United States	Massachussets General Hospital	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Lake Shore Gastroenterology & Liver Disease Inst.	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	University of Colorado, Denver	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	Research Specialist of Texas	Houston	Texas
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	Scripps	La Jolla	California
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Liver Wellness Center	Little Rock	Arkansas
United States	John Hopkins University	Lutherville	Maryland
United States	North Shore Hospital	Manhasset	New York
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Minnesota Gastro	Minneapolis	Minnesota
United States	University Of Minnesota	Minneapolis	Minnesota
United States	Yale University Digestive Diseases	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	University of Nebraska Medical Ctr	Omaha	Nebraska
United States	Orlando Immunology Center	Orlando	Florida
United States	University of Mississippi	Oxford	Mississippi
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic AZ	Phoenix	Arizona
United States	Bon Secours St. Mary 's Hospital of Richmond (Liver Institute of Virginia)	Richmond	Virginia
United States	VCU Medical Center	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	PMG Research of Rocky Mount, LLC	Rocky Mount	North Carolina
United States	Saint Louis University	Saint Louis	Missouri
United States	UCSD Medical Center	San Diego	California
United States	UCSF/San Fran General Hospital	San Francisco	California
United States	Univ of California, San Francisco	San Francisco	California
United States	Southwest CARE Center	Santa Fe	New Mexico
United States	University of Washington	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Mountain View Medical Center	Valatie	New York
United States	Georgetown University	Washington	District of Columbia
United States	Howard University	Washington	District of Columbia
United States	Trial Management Associates (TMA)	Wilmington	North Carolina
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	University of Florida

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response (SVR)	The primary outcome measure is the occurence (yes or no) of SVR, defined as undetectable HCV RNA in serum at least 3 months after stopping therapy. Point estimates and confidence intervals will be calculated to describe the frequency of SVR in various sub-populations enrolled in HCV-TARGET.	24 months
Secondary	Treatment persistence	Treatment persistence will be the duration of treatment measured from the first dose of medication until treatment is discontinued. Reasons for premature discontinuation of treatment will be recorded.	24 months
Secondary	Virological breakthrough	The occurrence of virological breakthrough defined as an increase of HCV RNA by at least 1-log over nadir or to >100 IU if previously undetectable.	24 months
Secondary	Management of adverse events	Specific interventions to manage selected adverse events, such as anemia and skin rash, will be tabulated and described	24 months

External Links

•   All-oral direct-acting antiviral therapy in HCV-advanced liver disease is effective in real-world practice: observations through HCV-TARGET database
•   Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: results of the real-world, clinical practice HCV-TARGET study.
•   Effectiveness and Safety of Sofosbuvir-Based Regimens for Chronic HCV Genotype 3 Infection: Results of the HCV-TARGET Study.
•   Effectiveness of Ledipasvir-Sofosbuvir Combination in Patients With Hepatitis C Virus Infection and Factors Associated of Sustained Virologic Response.
•   Effectiveness of Simeprevir Plus Sofosbuvir, With or Without Ribavirin, in Real-World Patients With HCV Genotype 1 Infection.
•   Efficacy of Glecaprevir and Pibrentasvir in Patients With Genotype 1 Hepatitis C Virus Infection With Treatment Failure After NS5A Inhibitor Plus Sofosbuvir Therapy
•   Interferon-free therapy for genotype 1 hepatitis C in liver transplant recipients: Real-world experience from the hepatitis C therapeutic registry and research network.
•   Public-Private Partnership: Targeting Real-World Data for Hepatitis C Direct-Acting Antivirals.
•   Safety and Effectiveness of Ledipasvir and Sofosbuvir, With or Without Ribavirin, in Treatment-Experienced Patients With Genotype 1 Hepatitis C Virus Infection and Cirrhosis
•   Safety and efficacy of current direct-acting antiviral regimens in kidney and liver transplant recipients with hepatitis C: Results from the HCV-TARGET study
•   Safety and Efficacy of Sofosbuvir-Containing Regimens in Hepatitis C Infected Patients with Impaired Renal Function.
•   Safety profile of boceprevir and telaprevir in chronic hepatitis C: real world experience from HCV-TARGET.
•   Treatment Status of Hepatocellular Carcinoma Does Not Influence Rates of Sustained Virologic Response: An HCV-TARGET Analysis
•   Virological outcomes and treatment algorithms utilisation in observational study of patients with chronic hepatitis C treated with boceprevir or telaprevir.