Clinical trial NCT01474811: HCV-TARGET- Hepatitis C Therapeutic Registry and Research Network
Official title: HCV-TARGET: Hepatitis C Therapeutic Registry and Research Network - A Longitudinal, Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: Hepatitis
Hepatitis C
HCV-TARGET
HCV
Observational Study
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of Florida
First posted: 2011-11-18
Enrollment: 13559
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female adult patients: Aged 18 and older with chronic HCV treated with triple therapy (including protease inhibitors).

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sustained virological response (SVR)
timeFrame: 24 months
Secondary outcomes:
measure: Treatment persistence
timeFrame: 24 months
measure: Virological breakthrough
timeFrame: 24 months
measure: Management of adverse events
timeFrame: 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic AZ
state: Arizona
city: Little Rock
country: United States
facility: Liver Wellness Center
state: Arkansas
city: La Jolla
country: United States
facility: Scripps
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF/San Fran General Hospital
state: California
city: San Francisco
country: United States
facility: Univ of California, San Francisco
state: California
city: Denver
country: United States
facility: University of Colorado, Denver
state: Colorado
city: New Haven
country: United States
facility: Yale University Digestive Diseases
state: Connecticut
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Washington
country: United States
facility: Howard University
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Medical Center
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Lake Shore Gastroenterology & Liver Disease Inst.
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Lutherville
country: United States
facility: John Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachussets General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Harvard University/ Beth Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Gastro
state: Minnesota
city: Minneapolis
country: United States
facility: University Of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Oxford
country: United States
facility: University of Mississippi
state: Mississippi
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Ctr
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Santa Fe
country: United States
facility: Southwest CARE Center
state: New Mexico
city: Beacon
country: United States
facility: Hudson River Healthcare
state: New York
city: Manhasset
country: United States
facility: North Shore Hospital
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: Valatie
country: United States
facility: Mountain View Medical Center
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Assoc
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount, LLC
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates (TMA)
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Austin
country: United States
facility: Austin Hepatitis Center
state: Texas
city: Austin
country: United States
facility: MetaClin Research, Inc
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: Research Specialist of Texas
state: Texas
city: Annandale
country: United States
facility: Metropolitan Liver Diseases and Gastroenterology
state: Virginia
city: Richmond
country: United States
facility: Bon Secours St. Mary 's Hospital of Richmond (Liver Institute of Virginia)
state: Virginia
city: Richmond
country: United States
facility: VCU Medical Center
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Toronto
country: Canada
facility: Liver Clinic, Toronto Western Hospital, UHN
state: Ontario
city: Aachen
country: Germany
facility: RWTH University Hospital
city: Frankfurt
country: Germany
facility: J. W. Goethe University Hospital
city: Hanover
country: Germany
facility: Hanover Medical School
city: San Juan
country: Puerto Rico
facility: Fundacion de investigacion de Diego
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Michael W. Fried, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: David R. Nelson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verna EC, Morelli G, Terrault NA, Lok AS, Lim JK, Di Bisceglie AM, Zeuzem S, Landis CS, Kwo P, Hassan M, Manns MP, Vainorius M, Akushevich L, Nelson DR, Fried MW, Reddy KR. DAA therapy and long-term hepatic function in advanced/decompensated cirrhosis: Real-world experience from HCV-TARGET cohort. J Hepatol. 2020 Sep;73(3):540-548. doi: 10.1016/j.jhep.2020.03.031. Epub 2020 Mar 31.
citation: Reddy KR, Lim JK, Kuo A, Di Bisceglie AM, Galati JS, Morelli G, Everson GT, Kwo PY, Brown RS Jr, Sulkowski MS, Akuschevich L, Lok AS, Pockros PJ, Vainorius M, Terrault NA, Nelson DR, Fried MW, Manns MP; HCV-TARGET Study Group. All-oral direct-acting antiviral therapy in HCV-advanced liver disease is effective in real-world practice: observations through HCV-TARGET database. Aliment Pharmacol Ther. 2017 Jan;45(1):115-126. doi: 10.1111/apt.13823. Epub 2016 Oct 28.
citation: Terrault NA, Zeuzem S, Di Bisceglie AM, Lim JK, Pockros PJ, Frazier LM, Kuo A, Lok AS, Shiffman ML, Ben Ari Z, Akushevich L, Vainorius M, Sulkowski MS, Fried MW, Nelson DR; HCV-TARGET Study Group. Effectiveness of Ledipasvir-Sofosbuvir Combination in Patients With Hepatitis C Virus Infection and Factors Associated With Sustained Virologic Response. Gastroenterology. 2016 Dec;151(6):1131-1140.e5. doi: 10.1053/j.gastro.2016.08.004. Epub 2016 Aug 24.
citation: Welzel TM, Nelson DR, Morelli G, Di Bisceglie A, Reddy RK, Kuo A, Lim JK, Darling J, Pockros P, Galati JS, Frazier LM, Alqahtani S, Sulkowski MS, Vainorius M, Akushevich L, Fried MW, Zeuzem S; HCV-TARGET Study Group. 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. Gut. 2017 Oct;66(10):1844-1852. doi: 10.1136/gutjnl-2016-311609. Epub 2016 Jul 13.
citation: Saxena V, Koraishy FM, Sise ME, Lim JK, Schmidt M, Chung RT, Liapakis A, Nelson DR, Fried MW, Terrault NA; HCV-TARGET. Safety and efficacy of sofosbuvir-containing regimens in hepatitis C-infected patients with impaired renal function. Liver Int. 2016 Jun;36(6):807-16. doi: 10.1111/liv.13102. Epub 2016 Mar 24.
citation: Sulkowski MS, Vargas HE, Di Bisceglie AM, Kuo A, Reddy KR, Lim JK, Morelli G, Darling JM, Feld JJ, Brown RS, Frazier LM, Stewart TG, Fried MW, Nelson DR, Jacobson IM; HCV-TARGET Study Group. Effectiveness of Simeprevir Plus Sofosbuvir, With or Without Ribavirin, in Real-World Patients With HCV Genotype 1 Infection. Gastroenterology. 2016 Feb;150(2):419-29. doi: 10.1053/j.gastro.2015.10.013. Epub 2015 Oct 21.
citation: Sterling RK, Kuo A, Rustgi VK, Sulkowski MS, Stewart TG, Fenkel JM, El-Genaidi H, Mah'moud MA, Abraham GM, Stewart PW, Akushevich L, Nelson DR, Fried MW, Di Bisceglie AM. Virological outcomes and treatment algorithms utilisation in observational study of patients with chronic hepatitis C treated with boceprevir or telaprevir. Aliment Pharmacol Ther. 2015 Apr;41(7):671-85. doi: 10.1111/apt.13095. Epub 2015 Jan 28.