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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03896087




Registration number
NCT03896087
Ethics application status
Date submitted
14/03/2019
Date registered
29/03/2019
Date last updated
17/12/2020

Titles & IDs
Public title
Evaluation of Dried Blood Spot for HCV RNA Testing
Scientific title
Multicentre Clinical Trial to Assess the Performance of Centralized Assays for Hepatitis C Virus RNA Detection From Dried Blood Spot (DBS) Samples
Secondary ID [1] 0 0
8160-2/1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Abbott RealTime HCV assay from DBS
Diagnosis / Prognosis - HCV for use on the cobas® 6800/8800 Systems from PSC and DBS
Diagnosis / Prognosis - Aptima® HCV Quant Dx Assay from DBS
Diagnosis / Prognosis - HCV for use on the cobas® 4800Systems from PSC and DBS

Experimental: clinical performance of the HCV DBS assay - The study will be conducted in different geographical regions and populations and is designed to meet requirements of the for assays (medical devices) used for the qualitative and quantitative detection of Hepatitis C RNA.

Active comparator: comparison PQ marked reference assay arm - Plasma specimens from the participants will be tested on Abbott RealTime HCV assay that is approved for HCV diagnostics use by countries' authorities.


Diagnosis / Prognosis: Abbott RealTime HCV 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. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.

Diagnosis / Prognosis: HCV for use on the cobas® 6800/8800 Systems from PSC and DBS
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays cobas® 6800/8800 Systems for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.

Diagnosis / Prognosis: 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 Aptima® HCV Quant Dx Assay from DBS for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.

Diagnosis / Prognosis: HCV for use on the cobas® 4800Systems from PSC and DBS
The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays cobas® 4800 for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
day 1 - day 30
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
day 1 - day 30
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
day 1 - day 30
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
day 1 - day 30
Secondary outcome [3] 0 0
WHO technician's appraisal sheet completed by all operators performing investigational test
Timepoint [3] 0 0
through study completion, an average of 1 year
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
day 7 - day 30
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
day 7 - day 30

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2020
Sample size
Target
Accrual to date
Final
942
Recruitment in Australia
Recruitment state(s)
Fitzro
Recruitment hospital [1] 0 0
St Vincent's Institute of Medical Research National Serology Reference Laboratory - Victoria Park
Recruitment postcode(s) [1] 0 0
3065 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
Cameroon
State/province [1] 0 0
Yaounde
Country [2] 0 0
Georgia
State/province [2] 0 0
Tbilisi
Country [3] 0 0
Greece
State/province [3] 0 0
Athens
Country [4] 0 0
Rwanda
State/province [4] 0 0
Kanombe

Funding & Sponsors
Primary sponsor type
Other
Name
Foundation for Innovative New Diagnostics, Switzerland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
UNITAID
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
FIND is preparing a study to evaluate the performance, as measured by sensitivity and specificity, of four centralized assays for the detection of HCV RNA using capillary blood collected on dried blood spots (DBS) and plasma separation card (PSC).
Trial website
https://clinicaltrials.gov/study/NCT03896087
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elena Ivanova, Ph.D.
Address 0 0
Foundation for Innovative New Diagnostics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03896087