Clinical Performance Evaluation of DxN HCV Assay

NCT03125408 | Terminated

• 1 other identifier: HCV 2.7.3.001
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Sustained Virologic Response (SVR)

  Defined as unquantifiable HCV Viral load after discontinuation of therapy

  Up to 9 months

Study Arms (1)

chronic HCV Infected patients

chronic HCV patients who will undergo standard of care FDA approved antiviral therapy to treat genotype 1,2, or 3 infections and will have blood drawn at various time points and tested using the DxN HCV Assay. Study is observational and results will not be used to manage patient care.

Diagnostic Test: HCV Assay

Interventions

HCV Assay DIAGNOSTIC_TEST

Molecular diagnostic test to detect Hepatitus C

Also known as: DxN HCV Assay

chronic HCV Infected patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects 18 years of age or older with chronic HCV who will undergo antiviral therapy to treat genotype 1,2 or 3 infections.

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

Sponsors & Collaborators

• Beckman Coulter, Inc.: lead

Study Sites (1)

SC Liver Research Consortium

Duluth, Georgia, 30096, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen plasma samples are retained for this study and possible future studies.

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 24, 2017
• Study Start: May 2, 2012
• Primary Completion: August 30, 2017
• Study Completion: August 30, 2017
• Last Updated: July 12, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)