Clinical Performance Evaluation of DxN HCV Assay

Stopped early

Conditions studied: Hepatitis C

In brief

The DxN Hepatitis C Virus (HCV) Assay is an in vitro diagnostic assay intended as an aid in the management of of HCV-infected individuals undergoing antiviral therapy. The purpose of the study is to establish the clinical performance of the DxN HCV Assay for plasma samples in the intended use population.

Key facts

Study ID

NCT03125408

Run by

Beckman Coulter, Inc.

People needed

210

Starts

2012-05-02

Expected to finish

2017-08-30

Last updated by the study team

2018-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is 18 years of age or older
• Subject has measurable HCV-RNA at baseline (prior to treatment start)
• Subject is genotype 2 or 3 and plans to undergo treatment with Peginterferon (PEG) plus Ribavirin (RBV) or Sofosbuvir (SOF) plus RIB
• Subject is genotype 1 and plans to undergo treatment with Telaprevir (TEL) or SOF plus PEG+RBV or, SOF plus Ledipasivr (LED)
• Subject is able to under information given, and willing and able to voluntarily give their consent to participate in study including signing consent form.

You may not qualify if…

• Co-infection with HIV or Hepatitis B (HBV)
• Prior participation in study
• Current participation in an investigation drug or device study

Where it is running

• SC Liver Research Consortium — Duluth, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.