HCV-TARGET- Hepatitis C Therapeutic Registry and Research Network

  • STATUS
    Recruiting
  • days left to enroll
    25
  • participants needed
    15000
  • sponsor
    University of North Carolina, Chapel Hill
Updated on 19 August 2020
Investigator
Stephanie Katz, MSN,RN
Primary Contact
John Hopkins University (6.5 mi away) Contact
+46 other location
telaprevir
antiviral drugs
chronic hepatitis
boceprevir

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.

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.

Details
Clinical Study IdentifierNCT01474811
SponsorUniversity of North Carolina, Chapel Hill
Last Modified on19 August 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Hepatitis C virus or Hepatitis C?
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
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