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

Hepatitis C Clinical Trial

— VINTAGE VHC  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574884
• Other study ID #: AORT10-DB / VINTAGE VHC
• Status: Completed
• Phase: N/A
• First received: October 2, 2015
• Last updated: October 12, 2015
• Start date: August 2011
• Est. completion date: July 2013

Study information

• Verified date: October 2015
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Procedure:
• Blood sample (act specific of blood withdrawal for the study)
Specific intervention : blood sample (3x7 ml in total)

Locations

Country	Name	City	State
France	Chru de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV serological markers	Immunoblot analysis from blood samples collected during the study	up to 30 months	No