Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:
Alexander Kuo

Description

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.

Official Title

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

Details

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.

Keywords

Hepatitis C Hepatitis HCV-TARGET HCV Observational Study Hepatitis A

Eligibility

You can join if…

Open to people ages 18 years and up

  • All adult patients (age 18 or older) being treated with antiviral HCV treatment regimens that contain telaprevir or boceprevir.

You CAN'T join if...

  • 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.

Locations

  • UCSD Medical Center accepting new patients
    San Diego California 92103 United States
  • Scripps accepting new patients
    La Jolla California 92037 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of North Carolina, Chapel Hill
Links
Virological outcomes and treatment algorithms utilisation in observational study of patients with chronic hepatitis C treated with boceprevir or telaprevir.
Safety profile of boceprevir and telaprevir in chronic hepatitis C: real world experience from HCV-TARGET.
Safety and Efficacy of Sofosbuvir-Containing Regimens in Hepatitis C Infected Patients with Impaired Renal Function.
Interferon-free therapy for genotype 1 hepatitis C in liver transplant recipients: Real-world experience from the hepatitis C therapeutic registry and research network.
Effectiveness of Simeprevir Plus Sofosbuvir, With or Without Ribavirin, in Real-World Patients With HCV Genotype 1 Infection.
Effectiveness of Ledipasvir-Sofosbuvir Combination in Patients With Hepatitis C Virus Infection and Factors Associated of Sustained Virologic Response.
Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: results of the real-world, clinical practice HCV-TARGET study.
Effectiveness and Safety of Sofosbuvir-Based Regimens for Chronic HCV Genotype 3 Infection: Results of the HCV-TARGET Study.
Safety and Effectiveness of Ledipasvir and Sofosbuvir, With or Without Ribavirin, in Treatment-Experienced Patients With Genotype 1 Hepatitis C Virus Infection and Cirrhosis
Safety and efficacy of current direct-acting antiviral regimens in kidney and liver transplant recipients with hepatitis C: Results from the HCV-TARGET study
All-oral direct-acting antiviral therapy in HCV-advanced liver disease is effective in real-world practice: observations through HCV-TARGET database
ID
NCT01474811
Lead Scientist
Alexander Kuo
Study Type
Observational
Last Updated