Back to resultsIdentification of Viral Variants Involved in the Transmission of Hepatitis C and Characterization of Antigenic and Functional Properties of Their Envelope Glycoproteins (VINTAGE VHC)
Primary Purpose
Hepatitis C
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample (act specific of blood withdrawal for the study)
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis C
Eligibility Criteria
Inclusion Criteria:
- age > 18 years
- agree to participate in this study (signing the consent form or information form signed and letter of no objection for subjects contaminated by blood exposure).
These criteria are specific to contaminated subjects:
- primary infection before development of HCV antibody (seroconversion): nucleic acid testing positive in the absence of HCV antibodies.
These criteria are specific to individual sources :
- HCV antibody positive.
Exclusion Criteria:
- refusal to participate
- private about freedom
- under guardianship
- under justice
- minor or major person unable to consent
Sites / Locations
- Chru de Tours
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
No Intervention
Other
Arm Label
Recently infected subjects
Retrospective cases
Individuals sources
Arm Description
Actual population of blood donors primo-infected with HCV with specific intervention for the study : one blood sample during the inclusion visit
Population of infected blood donors in 2007, 2008 and 2009 No blood sample
Specific intervention for the study : one blood sample during the inclusion visit
Outcomes
Primary Outcome Measures
HCV serological markers
Immunoblot analysis from blood samples collected during the study
Secondary Outcome Measures
Full Information
NCT ID
NCT02574884
First Posted
October 2, 2015
Last Updated
October 12, 2015
Sponsor
University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT02574884
Brief Title
Identification of Viral Variants Involved in the Transmission of Hepatitis C and Characterization of Antigenic and Functional Properties of Their Envelope Glycoproteins
Acronym
VINTAGE VHC
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study consists to Identify viral variants involved in the transmission of hepatitis C and characterize the antigenic and functional properties of their envelope glycoproteins at very early stage of infection (before seroconversion).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recently infected subjects
Arm Type
Other
Arm Description
Actual population of blood donors primo-infected with HCV with specific intervention for the study : one blood sample during the inclusion visit
Arm Title
Retrospective cases
Arm Type
No Intervention
Arm Description
Population of infected blood donors in 2007, 2008 and 2009 No blood sample
Arm Title
Individuals sources
Arm Type
Other
Arm Description
Specific intervention for the study : one blood sample during the inclusion visit
Intervention Type
Procedure
Intervention Name(s)
Blood sample (act specific of blood withdrawal for the study)
Intervention Description
Specific intervention : blood sample (3x7 ml in total)
Primary Outcome Measure Information:
Title
HCV serological markers
Description
Immunoblot analysis from blood samples collected during the study
Time Frame
up to 30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 18 years
agree to participate in this study (signing the consent form or information form signed and letter of no objection for subjects contaminated by blood exposure).
These criteria are specific to contaminated subjects:
primary infection before development of HCV antibody (seroconversion): nucleic acid testing positive in the absence of HCV antibodies.
These criteria are specific to individual sources :
HCV antibody positive.
Exclusion Criteria:
refusal to participate
private about freedom
under guardianship
under justice
minor or major person unable to consent
Facility Information:
Facility Name
Chru de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
12. IPD Sharing Statement
Learn more about this trial
Identification of Viral Variants Involved in the Transmission of Hepatitis C and Characterization of Antigenic and Functional Properties of Their Envelope Glycoproteins
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