HCV-TARGET- Hepatitis C Therapeutic Registry and Research Network

This study is currently recruiting participants.
Verified February 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
Michael Fried, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01474811
First received: November 10, 2011
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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
Hepatitis C

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: HCV-TARGET: Hepatitis C Therapeutic Registry and Research Network - A Longitudinal, Observational Study.

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 4500
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)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474811

  Show 33 Study Locations
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
  More Information

No publications provided

Responsible Party: Michael Fried, MD, Professor of Medicine, Director, UNC Liver Center, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01474811     History of Changes
Other Study ID Numbers: HCV-TARGET Study
Study First Received: November 10, 2011
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Hepatitis
Hepatitis C
HCV-TARGET
HCV
Observational Study

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 16, 2014