HCV-TARGET- Hepatitis C Therapeutic Registry and Research Network

February 23, 2024 updated by: University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

13559

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Liver Clinic, Toronto Western Hospital, UHN
  • Germany
      • Aachen, Germany
        • RWTH University Hospital
      • Frankfurt, Germany, DE-60590
        • J. W. Goethe University Hospital
      • Hanover, Germany
        • Hanover Medical School
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion de Diego
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic AZ
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Liver Wellness Center
    • California
      • La Jolla, California, United States, 92037
        • Scripps
      • San Diego, California, United States, 92103
        • UCSD Medical Center
      • San Francisco, California, United States, 94143
        • Univ of California, San Francisco
      • San Francisco, California, United States, 94110
        • UCSF/San Fran General Hospital
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado, Denver
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University Digestive Diseases
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard University
      • Washington, District of Columbia, United States, 20007
        • Georgetown University
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Atlanta, Georgia, United States, 30312
        • Atlanta Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60016
        • Lake Shore Gastroenterology & Liver Disease Inst.
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • John Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachussets General Hospital
      • Boston, Massachusetts, United States, 02215
        • Harvard University/ Beth Deaconess Medical Center
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Minnesota Gastro
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Oxford, Mississippi, United States, 38677
        • University of Mississippi
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • Saint Louis University
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • University of Nebraska Medical Ctr
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • Southwest CARE Center
    • New York
      • Beacon, New York, United States, 12508
        • Hudson River Healthcare
      • Manhasset, New York, United States, 11030
        • North Shore Hospital
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
      • Valatie, New York, United States, 12184
        • Mountain View Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Assoc
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Rocky Mount, North Carolina, United States, 27804
        • PMG Research of Rocky Mount, LLC
      • Wilmington, North Carolina, United States, 28403
        • Trial Management Associates (TMA)
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Texas
      • Austin, Texas, United States, 78758
        • Austin Hepatitis Center
      • Austin, Texas, United States, 78758
        • MetaClin Research, Inc
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Houston, Texas, United States, 77030
        • Research Specialist of Texas
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Metropolitan Liver Diseases and Gastroenterology
      • Richmond, Virginia, United States, 23298
        • VCU Medical Center
      • Richmond, Virginia, United States, 23226
        • Bon Secours St. Mary 's Hospital of Richmond (Liver Institute of Virginia)
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98104
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained virological response (SVR)
Time Frame: 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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment persistence
Time Frame: 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.
24 months
Virological breakthrough
Time Frame: 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.
24 months
Management of adverse events
Time Frame: 24 months
Specific interventions to manage selected adverse events, such as anemia and skin rash, will be tabulated and described
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

September 9, 2022

Study Completion (Actual)

September 9, 2022

Study Registration Dates

First Submitted

November 10, 2011

First Submitted That Met QC Criteria

November 15, 2011

First Posted (Estimated)

November 18, 2011

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-1991

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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