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

Not Applicable

Completed

• Conditions: Hepatitis C
• Interventions: Procedure: Blood sample (act specific of blood withdrawal for the study)

• Registration Number: NCT02574884
• Lead Sponsor: University Hospital, Tours

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2013-01
• Study Completion: 2013-07
• Status Verified: 2015-10
• Study First Submitted: 2015-10-02
• Study First Submitted QC: 2015-10-12
• Last Update Submitted: 2015-10-12
• Study First Posted: 2015-10-14
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recently infected subjects	Blood sample (act specific of blood withdrawal for the study)	Actual population of blood donors primo-infected with HCV with specific intervention for the study : one blood sample during the inclusion visit
Individuals sources	Blood sample (act specific of blood withdrawal for the study)	Specific intervention for the study : one blood sample during the inclusion visit

Primary Outcome Measures

Name	Time	Method
HCV serological markers	up to 30 months	Immunoblot analysis from blood samples collected during the study

Trial Locations

Locations (1)

Chru de Tours; 🇫🇷 Tours, France