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Evaluation DBS for HCV RNA Testing

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ClinicalTrials.gov Identifier: NCT03896087
Recruitment Status : Not yet recruiting
First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Collaborator:
UNITAID
Information provided by (Responsible Party):
Foundation for Innovative New Diagnostics, Switzerland

Brief Summary:
FIND is preparing a study to evaluate the performance, as measured by sensitivity and specificity, of three centralized assays for the detection of HCV RNA using capillary blood collected on dried blood spots (DBS) and plasma separation card (PSC).

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Diagnostic Test: Abbott RealTime HCV assay from DBS; COBAS® AmpliPrep/COBAS TaqMan HCV Test from DBS; cobas® HCV for use on the cobas® 6800/8800 Systems from PSC and DBS; Aptima® HCV Quant Dx Assay from DBS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 815 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multicentre Clinical Trial to Assess the Performance of Centralized Assays for Hepatitis C Virus RNA Detection From Dried Blood Spot (DBS) Samples
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Abbott RealTime HCV assay from DBS; COBAS® AmpliPrep/COBAS TaqMan HCV Test from DBS; cobas® HCV for use on the cobas® 6800/8800 Systems from PSC and DBS; Aptima® HCV Quant Dx Assay from DBS
    The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays for detection of HCV RNA.


Primary Outcome Measures :
  1. Point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection from DBS and/or PSC specimens measured against Abbott RealTime HCV VL assay performed at the clinical site [ Time Frame: day 1 - day 30 ]
  2. Evaluation of the correlation of HCV viral load level determined by each assay performed from DBS and/or PSC specimens with the HCV viral load level in plasma determined by Abbott RealTime HCV VL assay performed at the clinical site [ Time Frame: day 1 - day 30 ]

Secondary Outcome Measures :
  1. Point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection from DBS and/or PSC specimens measured against the performance of the same assay in plasma [ Time Frame: day 1 - day 30 ]
  2. Evaluation of the correlation of HCV viral load level determined by each assay performed from DBS and/or PSC specimens with the HCV RNA level in plasma determined by the same assay [ Time Frame: day 1 - day 30 ]
  3. WHO technician's appraisal sheet completed by all operators performing investigational test [ Time Frame: through study completion, an average of 1 year ]
  4. point estimates (with 95% confidence intervals) of sensitivity and specificity for each assay for HCV RNA detection in plasma measured against the performance of Roche cobas® 6800 HCV VL assay [ Time Frame: day 7 - day 30 ]
    For Central Laboratory only

  5. evaluation of the correlation of HCV RNA levels in plasma determined by each assay with HCV RNA levels in plasma determined by Roche cobas® 6800 HCV VL assay [ Time Frame: day 7 - day 30 ]
    For Central Laboratory only



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Three different population groups will be considered:

  1. Individuals at risk of having HCV infection based on positive HCV serology test results

    Inclusion criteria:

    • Aged 18 years or older
    • Able to understand the scope of the trial
    • Provided written informed consent
    • Documented positive result of HCV serology test
  2. Individuals at risk of having HCV infection based on past and/or current exposure to risk factors

    Inclusion criteria:

    • Aged 18 years or older
    • Able to understand the scope of the trial
    • Provided written informed consent
    • Past and/or current exposure to one of the high risk factors as defined by WHO and CDC guidelines (Appendix I)
  3. Individuals diagnosed with chronic HCV infection who initiated or completed the anti-HCV treatment with direct acting antivirals (DAA) presenting at the clinical site for treatment monitoring or test of cure (i.e. sustained virological response)

Inclusion criteria:

  • Aged 18 years or older
  • Able to understand the scope of the trial
  • Provided written informed consent
  • Initiated on DAA treatment (regardless of type of DAA regimen) within 12 months prior to the enrolment to the trial

Exclusion criteria (for all trial populations):

  • Previously enrolled in the trial
  • Unwilling to provide required volume of fingerstick blood
  • Unwilling to provide required volume of venous whole blood

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): NCT03896087


Contacts
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Contact: Elena Ivanova, Ph.D. +41 22 749 29 48 elena.ivanova@finddx.org

Sponsors and Collaborators
Foundation for Innovative New Diagnostics, Switzerland
UNITAID

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Responsible Party: Foundation for Innovative New Diagnostics, Switzerland
ClinicalTrials.gov Identifier: NCT03896087     History of Changes
Other Study ID Numbers: 8160-2/1
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Foundation for Innovative New Diagnostics, Switzerland:
dried blood spots
plasma separation card
HCV RNA test
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic