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Qualification of Point-of-Care Assays for Management of HCV Patients (ANRS HC POC)

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ClinicalTrials.gov Identifier: NCT02335320
Recruitment Status : Unknown
Verified March 2015 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).
Recruitment status was:  Recruiting
First Posted : January 9, 2015
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

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.


Condition or disease
Hepatitis C

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Study Type : Observational
Estimated Enrollment : 250 participants
Time Perspective: Cross-Sectional
Official Title: Qualification of Point-of-Care Assays for Management of HCV Patients
Study Start Date : March 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. proportion of patients with genotype IL-28B C/C versus IL-28B non C/C patients [ Time Frame: D1 ]
    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.


Secondary Outcome Measures :
  1. proportion of patients of whom the genotype results are identical between the index test and the gold standard test. [ Time Frame: D1 ]
    For secondary endpoints the three genotypes (C/C, C/T, T/T) are considered



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HCV chronic patients (all viral genotypes)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335320


Contacts
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Contact: Stanislas Pol, Professor 1 58 41 30 01 ext +33 stanislas.pol@cch.pasteur.fr

Locations
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France
Groupe Hospitalier Cochin Saint-Vincent de Paul Recruiting
Paris, France, 75679
Contact: Stanislas Pol, Professor    1 58 41 30 01 ext +33    stanislas.pol@cch.pasteur.fr   
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
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Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT02335320    
Other Study ID Numbers: ANRS HC POC
First Posted: January 9, 2015    Key Record Dates
Last Update Posted: March 23, 2015
Last Verified: March 2015
Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
VHC
IL28-B
point of care
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections