Qualification of Point-of-Care Assays for Management of HCV Patients

NCT02335320 | Unknown

• 1 other identifier: ANRS HC POC
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Acute or chronic HCV infection can lead to liver complications, including liver failure, cirrhosis or liver cancer. For patients with hepatitis C infection, the major clinical question remains the terms of treatment initiation. In Europe, new treatments are available since the approval of three direct acting antivirals. However with the high cost of these treatments, they are currently only available for critically ill patients. Other molecules are currently in advanced clinical development phases. The use of clinical predictors remains relevant for the selection of a suitable treatment for each patient, in particular to limit the adverse effects and reduce costs. Currently the quantification of viral load is a measure of response to treatment; with the recommendation to stop treatment in patients who fail to achieve an undetectable level of viral load. Genetic factors have also been identified as predictors of response to treatment, in particular polymorphisms of the IL-28B gene. Genotyping of this gene is currently performed using classical PCR amplification applied to DNA extracted from blood, with a time to result of 2-3 weeks. We propose in this protocol to test a non-invasive method and rapid test for IL-28B genotype which could be used for point of caring testing, and ultimately better patient management. This is a monocenter, cross-sectional study among HCV chronic patients. The study will be conducted in 250 HCV patients, all viral genotypes combined, at Cochin Hospital (Paris, France). Objectives The principal objective is to assess the accuracy of the newly developed Point-of-Care genotyping assay (Genedrive® IL-28B Assay) to detect in HCV patients the genotype CC versus non CC (i.e. CT and TT) against the TaqMan Allelic Discrimination Assay as gold standard. The secondary objective is to assess the concordance between the genotype results of the Genedrive and the gold standard regarding the three genotypes CC, CT and TT.

Conditions

Hepatitis C

Keywords

VHC; IL28-B; point of care

Outcome Measures

Primary Outcomes (1)

• proportion of patients with genotype IL-28B C/C versus IL-28B non C/C patients

  The study is based on the comparison of the genotyping results for SNP rs1297860 (IL-28B gene) between the Genedrive® assay and the gold standard assay.

  D1

Secondary Outcomes (1)

• proportion of patients of whom the genotype results are identical between the index test and the gold standard test.

  D1

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

HCV chronic patients (all viral genotypes)

You may qualify if:

• Age \> 18 years old.
• Patients diagnosed with hepatitis C (all viral genotypes).
• Patient already treated or recommended to start antiviral therapy against hepatitis C virus or currently undergoing antiviral therapy.
• Patients who consented to IL-28B genotyping in the course of their usual follow-up by conventional PCR standard method.
• Patients affiliated to social security.
• Informed consent must be obtained for all subjects prior to study entry.

You may not qualify if:

• A person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (1)

Groupe Hospitalier Cochin Saint-Vincent de Paul

Paris, 75679, France

RECRUITING

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

Central Study Contacts

Stanislas Pol, Professor

CONTACT

1 58 41 30 01; stanislas.pol@cch.pasteur.fr

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: January 9, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 23, 2015

Record last verified: 2015-03

Locations

FR (1)