HCV-TARGET- Hepatitis C Therapeutic Registry and Research Network

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01474811

Collaborator

University of Florida (Other)

11,011

Enrollment

Locations

130

Duration (Months)

183.5

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C

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:

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 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.

Study Design

Study Type:

Observational

Actual Enrollment :

11011 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Nov 1, 2011

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Outcome Measures

Primary Outcome Measures

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

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.
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.
Management of adverse events [24 months]
Specific interventions to manage selected adverse events, such as anemia and skin rash, will be tabulated and described

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic AZ	Phoenix	Arizona	United States	85054
2	Liver Wellness Center	Little Rock	Arkansas	United States	72205
3	Scripps	La Jolla	California	United States	92037
4	UCSD Medical Center	San Diego	California	United States	92103
5	UCSF/San Fran General Hospital	San Francisco	California	United States	94110
6	Univ of California, San Francisco	San Francisco	California	United States	94143
7	University of Colorado, Denver	Denver	Colorado	United States	80045
8	Yale University Digestive Diseases	New Haven	Connecticut	United States	06520
9	Georgetown University	Washington	District of Columbia	United States	20007
10	Howard University	Washington	District of Columbia	United States	20060
11	University of Florida	Gainesville	Florida	United States	32611
12	University of Miami Miller School of Medicine	Miami	Florida	United States	33136
13	Orlando Immunology Center	Orlando	Florida	United States	32803
14	Atlanta Medical Center	Atlanta	Georgia	United States	30312
15	Emory University	Atlanta	Georgia	United States	30322
16	Lake Shore Gastroenterology & Liver Disease Inst.	Chicago	Illinois	United States	60016
17	Northwestern University	Chicago	Illinois	United States	60611
18	University of Chicago	Chicago	Illinois	United States	60637
19	Indiana University Medical Center	Indianapolis	Indiana	United States	46202
20	John Hopkins University	Lutherville	Maryland	United States	21093
21	Massachussets General Hospital	Boston	Massachusetts	United States	02114
22	Harvard University/ Beth Deaconess Medical Center	Boston	Massachusetts	United States	02215
23	University of Massachusetts Medical School	Worcester	Massachusetts	United States	01655
24	University of Michigan	Ann Arbor	Michigan	United States	48109
25	Henry Ford Hospital	Detroit	Michigan	United States	48202
26	Minnesota Gastro	Minneapolis	Minnesota	United States	55455
27	University Of Minnesota	Minneapolis	Minnesota	United States	55455
28	Mayo Clinic	Rochester	Minnesota	United States	55905
29	University of Mississippi	Oxford	Mississippi	United States	38677
30	Saint Louis University	Saint Louis	Missouri	United States	63104
31	University of Nebraska Medical Ctr	Omaha	Nebraska	United States	68105
32	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
33	Southwest CARE Center	Santa Fe	New Mexico	United States	87505
34	Hudson River Healthcare	Beacon	New York	United States	12508
35	North Shore Hospital	Manhasset	New York	United States	11030
36	Weill Cornell Medical College	New York	New York	United States	10021
37	Columbia University Medical Center	New York	New York	United States	10032
38	Mountain View Medical Center	Valatie	New York	United States	12184
39	Asheville Gastroenterology Assoc	Asheville	North Carolina	United States	28801
40	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
41	Duke University Medical Center	Durham	North Carolina	United States	27710
42	PMG Research of Rocky Mount, LLC	Rocky Mount	North Carolina	United States	27804
43	Trial Management Associates (TMA)	Wilmington	North Carolina	United States	28403
44	University of Cincinnati	Cincinnati	Ohio	United States	45267
45	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
46	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
47	Austin Hepatitis Center	Austin	Texas	United States	78758
48	MetaClin Research, Inc	Austin	Texas	United States	78758
49	Baylor University Medical Center	Dallas	Texas	United States	75246
50	Research Specialist of Texas	Houston	Texas	United States	77030
51	Metropolitan Liver Diseases and Gastroenterology	Annandale	Virginia	United States	22003
52	Bon Secours St. Mary 's Hospital of Richmond (Liver Institute of Virginia)	Richmond	Virginia	United States	23226
53	VCU Medical Center	Richmond	Virginia	United States	23298
54	Virginia Mason Medical Center	Seattle	Washington	United States	98101
55	University of Washington	Seattle	Washington	United States	98104
56	Liver Clinic, Toronto Western Hospital, UHN	Toronto	Ontario	Canada	M5T 2S8
57	RWTH University Hospital	Aachen		Germany
58	J. W. Goethe University Hospital	Frankfurt		Germany	DE-60590
59	Hanover Medical School	Hanover		Germany
60	Fundacion de investigacion de Diego	San Juan		Puerto Rico	00927

Sponsors and Collaborators

University of North Carolina, Chapel Hill
University of Florida

Investigators

Principal Investigator: Michael W. Fried, M.D., University of North Carolina, Chapel Hill
Principal Investigator: David R. Nelson, M.D., University of Florida