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HCV-TARGET- Hepatitis C Therapeutic Registry and Research Network

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ClinicalTrials.gov Identifier: NCT01474811
Recruitment Status : Recruiting
First Posted : November 18, 2011
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date November 10, 2011
First Posted Date November 18, 2011
Last Update Posted Date April 26, 2019
Study Start Date November 2011
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 15, 2011)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 15, 2011)
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title HCV-TARGET- Hepatitis C Therapeutic Registry and Research Network
Official Title HCV-TARGET: Hepatitis C Therapeutic Registry and Research Network - A Longitudinal, Observational Study.
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.

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).
Condition Hepatitis C
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 13, 2018)
15000
Original Estimated Enrollment
 (submitted: November 15, 2011)
4500
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Canada,   Germany,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01474811
Other Study ID Numbers 11-1991
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of North Carolina, Chapel Hill
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
PRS Account University of North Carolina, Chapel Hill
Verification Date April 2019