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

Hepatitis C Clinical Trial

— ANRS HC POC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02335320
• Other study ID #: ANRS HC POC
• Status: Recruiting
• Phase: N/A
• First received: November 24, 2014
• Last updated: March 20, 2015
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2015
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: Stanislas Pol, Professor
• Phone: 1 58 41 30 01
• Email: stanislas.pol[@]cch.pasteur.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hepatitis C

Locations

Country	Name	City	State
France	Groupe Hospitalier Cochin Saint-Vincent de Paul	Paris

Sponsors (1)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	proportion of patients of whom the genotype results are identical between the index test and the gold standard test.	For secondary endpoints the three genotypes (C/C, C/T, T/T) are considered	D1	No