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Overview

Patients are enrolled prospectively at participating sites and treated per local standard of care. HCV-TARGET does not define treatment regimens, dosing, or duration or safety management practices. Source data is the original medical record. All original clinic notes, telephone notes, safety and efficacy labs/evaluations collected during treatment and in the post treatment observation period are submitted to a central data repository. Pertinent data from submitted records is abstracted by specially trained staff at the HCV-TARGET clinical coordinating center. Some data is mapped directly from electronic medical records into the database using the REDCap Eletronic Data Importer (RED-I) software.

  • Demographics (gender, age, race, ethnicity, BMI, type of insurance)
  • Baseline factors (HCV viral load, HCV genotype, cirrhosis determination, IL-28b genotypes, prior HCV treatment, medical history, co-morbid conditions)
  • HCV treatment regimen and dose adjustments
  • Adverse Events
  • Concomitant Medications
  • Labs to monitor safety and efficacy
  • Long-term post treatment FU (co-morbid conditions, complications related to liver disease, mortality)

 

Regimens Time Table

Last Updated 04-2018

Data Collection

Patients are enrolled prospectively at participating sites and treated per local standard of care. HCV-TARGET does not define treatment regimens, dosing, or duration or safety management practices. Source data is the original medical record. All original clinic notes, telephone notes, safety and efficacy labs/evaluations collected during treatment and in the post treatment observation period are submitted to a central data repository. Pertinent data from submitted records is abstracted by specially trained staff at the HCV-TARGET clinical coordinating center. Some data is mapped directly from electronic medical records into the database using the REDCap Eletronic Data Importer (RED-I) software.

  • Demographics (gender, age, race, ethnicity, BMI, type of insurance)
  • Baseline factors (HCV viral load, HCV genotype, cirrhosis determination, IL-28b genotypes, prior HCV treatment, medical history, co-morbid conditions)
  • HCV treatment regimen and dose adjustments
  • Adverse Events
  • Concomitant Medications
  • Labs to monitor safety and efficacy
  • Long-term post treatment FU (co-morbid conditions, complications related to liver disease, mortality)

 

Regimens Time Table

Last Updated 04-2018

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