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

NCT ID: NCT02574884

Last Updated: 2015-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Blood sample (act specific of blood withdrawal for the study)

Intervention Type PROCEDURE

Specific intervention : blood sample (3x7 ml in total)

Retrospective cases

Population of infected blood donors in 2007, 2008 and 2009 No blood sample

Group Type NO_INTERVENTION

No interventions assigned to this group

Individuals sources

Specific intervention for the study : one blood sample during the inclusion visit

Group Type OTHER

Blood sample (act specific of blood withdrawal for the study)

Intervention Type PROCEDURE

Specific intervention : blood sample (3x7 ml in total)

Interventions

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Blood sample (act specific of blood withdrawal for the study)

Specific intervention : blood sample (3x7 ml in total)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chru de Tours

Tours, France, France

Site Status

Countries

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France

Other Identifiers

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AORT10-DB / VINTAGE VHC

Identifier Type: -

Identifier Source: org_study_id

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