Identification of Viral Variants Involved in the Transmission of Hepatitis C and Characterization of Antigenic and Functional Properties of Their Envelope Glycoproteins (VINTAGE VHC)

October 12, 2015 updated by: University Hospital, Tours
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37044
        • CHRU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Recently infected subjects
Actual population of blood donors primo-infected with HCV with specific intervention for the study : one blood sample during the inclusion visit
Procedure: Blood sample (act specific of blood withdrawal for the study)
Specific intervention : blood sample (3x7 ml in total)
No Intervention: Retrospective cases
Population of infected blood donors in 2007, 2008 and 2009 No blood sample
Other: Individuals sources
Specific intervention for the study : one blood sample during the inclusion visit
Procedure: Blood sample (act specific of blood withdrawal for the study)
Specific intervention : blood sample (3x7 ml in total)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCV serological markers
Time Frame: up to 30 months
Immunoblot analysis from blood samples collected during the study
up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

October 2, 2015

First Submitted That Met QC Criteria

October 12, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 12, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AORT10-DB / VINTAGE VHC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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