HCV-TARGET- Hepatitis C Therapeutic Registry and Research Network
- Conditions
- Hepatitis C
- Registration Number
- NCT01474811
- Lead Sponsor
- University of North Carolina, Chapel Hill
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13559
- All adult patients (age 18 or older) being treated with antiviral HCV treatment regimens that contain telaprevir or boceprevir.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sustained virological response (SVR) 24 months 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.
- Secondary Outcome Measures
Name Time Method Virological breakthrough 24 months 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.
Treatment persistence 24 months 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.
Management of adverse events 24 months Specific interventions to manage selected adverse events, such as anemia and skin rash, will be tabulated and described
Trial Locations
- Locations (60)
Northwestern University
🇺🇸Chicago, Illinois, United States
Asheville Gastroenterology Assoc
🇺🇸Asheville, North Carolina, United States
Massachussets General Hospital
🇺🇸Boston, Massachusetts, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Mayo Clinic AZ
🇺🇸Phoenix, Arizona, United States
Liver Wellness Center
🇺🇸Little Rock, Arkansas, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Atlanta Medical Center
🇺🇸Atlanta, Georgia, United States
Howard University
🇺🇸Washington, District of Columbia, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
John Hopkins University
🇺🇸Lutherville, Maryland, United States
Scripps
🇺🇸La Jolla, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Lake Shore Gastroenterology & Liver Disease Inst.
🇺🇸Chicago, Illinois, United States
North Shore Hospital
🇺🇸Manhasset, New York, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Austin Hepatitis Center
🇺🇸Austin, Texas, United States
Southwest CARE Center
🇺🇸Santa Fe, New Mexico, United States
Harvard University/ Beth Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Mississippi
🇺🇸Oxford, Mississippi, United States
Hudson River Healthcare
🇺🇸Beacon, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
J. W. Goethe University Hospital
🇩🇪Frankfurt, Germany
PMG Research of Rocky Mount, LLC
🇺🇸Rocky Mount, North Carolina, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Liver Clinic, Toronto Western Hospital, UHN
🇨🇦Toronto, Ontario, Canada
Hanover Medical School
🇩🇪Hanover, Germany
Weill Cornell Medical College
🇺🇸New York, New York, United States
MetaClin Research, Inc
🇺🇸Austin, Texas, United States
Mountain View Medical Center
🇺🇸Valatie, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Bon Secours St. Mary 's Hospital of Richmond (Liver Institute of Virginia)
🇺🇸Richmond, Virginia, United States
Trial Management Associates (TMA)
🇺🇸Wilmington, North Carolina, United States
RWTH University Hospital
🇩🇪Aachen, Germany
Fundacion de investigacion de Diego
🇵🇷San Juan, Puerto Rico
Research Specialist of Texas
🇺🇸Houston, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
VCU Medical Center
🇺🇸Richmond, Virginia, United States
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
UCSF/San Fran General Hospital
🇺🇸San Francisco, California, United States
Minnesota Gastro
🇺🇸Minneapolis, Minnesota, United States
UCSD Medical Center
🇺🇸San Diego, California, United States
University Of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Univ of California, San Francisco
🇺🇸San Francisco, California, United States
University of Colorado, Denver
🇺🇸Denver, Colorado, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Yale University Digestive Diseases
🇺🇸New Haven, Connecticut, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Nebraska Medical Ctr
🇺🇸Omaha, Nebraska, United States
Metropolitan Liver Diseases and Gastroenterology
🇺🇸Annandale, Virginia, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States