HCV-TARGET- Hepatitis C Therapeutic Registry and Research Network
The primary purpose of the HCV-TARGET study is to establish a nationwide registry of patients undergoing treatment with protease inhibitors (telaprevir and boceprevir) for chronic hepatitis C (HCV) at both academic and community practices.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||HCV-TARGET: Hepatitis C Therapeutic Registry and Research Network - A Longitudinal, Observational Study.|
- Sustained virological response (SVR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]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.
- Treatment persistence [ Time Frame: 24 months ] [ Designated as safety issue: No ]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.
- Virological breakthrough [ Time Frame: 24 months ] [ Designated as safety issue: No ]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.
- Management of adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Specific interventions to manage selected adverse events, such as anemia and skin rash, will be tabulated and described
Biospecimen Retention: Samples With DNA
All patients will be invited to participate in the HCV-TARGET Biorepository Specimen Bank (BSB).
The following will be collected: Blood (Serum and DNA).
All samples will be collected on a voluntary basis and participation in this project will not affect participation in the main study.
Samples collected will be stored at the University of Florida for up to 15 years after the end of the study (database closure) at which time they will be destroyed. The implementation and use of the BSB specimens is governed by the University of Florida Biospecimen Repository policy to ensure the appropriate use of the deposited samples.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
HCV-TARGET is a longitudinal, observational study that will create a carefully maintained research registry of patients treated with telaprevir or boceprevir 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 regimens containing boceprevir and telaprevir 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:
- 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.
- 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 telaprevir and boceprevir (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.
|United States, California|
|La Jolla, California, United States, 92037|
|Contact: Mary Helen Broussard 858-652-5419 Broussard.MaryHelen@scrippshealth.org|
|Principal Investigator: Paul Pockros, MD|
|United States, Colorado|
|University of Colorado, Denver||Recruiting|
|Denver, Colorado, United States, 80045|
|Contact: Jennifer DeSanto, RN 303-724-1861 email@example.com|
|Principal Investigator: Gregory Everson, MD|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32611|
|Contact: Joy Peter, BSN firstname.lastname@example.org|
|Principal Investigator: Giuseppe Morelli, M.D.|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Contact: Carole Seeley 404-712-7995 email@example.com|
|Principal Investigator: James Spivey, MD|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Monique Williams, MSN, RN 773-702-4477 firstname.lastname@example.org|
|Principal Investigator: Donald Jensen, MD|
|United States, Indiana|
|Indiana University Medical Center||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Martha Mendez, RN 317-278-4633 email@example.com|
|Principal Investigator: Paul Kwo, MD|
|United States, Maryland|
|John Hopkins University||Recruiting|
|Lutherville, Maryland, United States, 21093|
|Contact: Stacey Wilson 410-616-2830 firstname.lastname@example.org|
|Principal Investigator: Mark Sulkowski, MD|
|United States, Massachusetts|
|Harvard University/ Beth Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Saima Firdoos 617-632-1129 email@example.com|
|Principal Investigator: Nezam Afdhal, MD|
|United States, Michigan|
|Henry Ford Hospital||Recruiting|
|Detroit, Michigan, United States, 48202|
|Contact: Rebecca Fleckenstein 313-916-1962 firstname.lastname@example.org|
|Principal Investigator: Stuart C Gordon, MD|
|United States, Missouri|
|Saint Louis University||Recruiting|
|Saint Louis, Missouri, United States, 63104|
|Contact: Karri L Moore 314-977-9400 email@example.com|
|Principal Investigator: Adrian DiBisceglie, MD|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10021|
|Contact: William Duffie 646-962-4742 firstname.lastname@example.org|
|Principal Investigator: Ira M Jacobson, MD|
|United States, North Carolina|
|University of North Carolina at Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Tiffany Pritchett, B.A. email@example.com|
|Principal Investigator: Michael W. Fried, M.D|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: William T Hunt, CCRP 919-684-3493 firstname.lastname@example.org|
|Principal Investigator: Anrdrew Muir, MD|
|United States, Ohio|
|University of Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45267|
|Contact: Susan Sibert, RN, CCRC 513-584-2363 email@example.com|
|Principal Investigator: Kenneth Sherman, MD|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Amina Wirjosemito 215-615-5471 Amina.Wirjosemito@uphs.upenn.edu|
|Principal Investigator: Rajender Reddy, MD|
|Fundacion de investigacion de Diego||Recruiting|
|San Juan, Puerto Rico, 00927|
|Contact: Roberto Galarza 787-722-1248 firstname.lastname@example.org|
|Principal Investigator: Maribel Rodriguez-Torres, MD|
|Principal Investigator:||Michael W. Fried, M.D.||University of North Carolina, Chapel Hill|
|Principal Investigator:||David R. Nelson, M.D.||University of Florida|