Hepatitis CVINTAGE VHCNCT02574884
Identification of Viral Variants Involved in the Transmission of Hepatitis C and Characterization of Antigenic and Functional Properties of Their Envelope Glycoproteins
A study testing Blood sample (act specific of blood withdrawal for the study) in people with Hepatitis C, run by University Hospital, Tours at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Blood sample (act specific of blood withdrawal for the study)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2011to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- refusal to participate
- private about freedom
- under guardianship
- under justice
- minor or major person unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Hepatitis C
- Being tested
- Blood sample (act specific of blood withdrawal for the study)
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample (act specific of blood withdrawal for the study)Procedure or surgery
Specific intervention : blood sample (3x7 ml in total)
| Study group | Role | What they receive |
|---|---|---|
| Recently infected subjects | Other | Actual population of blood donors primo-infected with HCV with specific intervention for the study : one blood sample during the inclusion visit Receives: Procedure: Blood sample (act specific of blood withdrawal for the study) |
| Retrospective cases | No intervention | Population of infected blood donors in 2007, 2008 and 2009 No blood sample |
| Individuals sources | Other | Specific intervention for the study : one blood sample during the inclusion visit Receives: Procedure: Blood sample (act specific of blood withdrawal for the study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV serological markers
Immunoblot analysis from blood samples collected during the study
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startAug 2011
- Primary completionJan 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574884
- Sponsor's protocol ID
- AORT10-DB / VINTAGE VHC
- Acronym
- VINTAGE VHC
- Status last verified
- Oct 2015
- First submitted
- 2 Oct 2015
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Viral Variants Involved in the Transmission of Hepatitis C and Characterization of Antigenic and Functional Properties of Their Envelope Glycoproteins
- ClinicalTrials.gov ID
- NCT02574884
- Acronym / sponsor ID
- VINTAGE VHC / AORT10-DB / VINTAGE VHC
- Conditions
- Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 14 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Recently infected subjects | Other | Procedure: 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 |
| Retrospective cases | No intervention | –Population of infected blood donors in 2007, 2008 and 2009 No blood sample |
| Individuals sources | Other | Procedure: Blood sample (act specific of blood withdrawal for the study)Specific intervention for the study : one blood sample during the inclusion visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
- primary infection before development of HCV antibody (seroconversion): nucleic acid testing positive in the absence of HCV antibodies.
- HCV antibody positive.
Key exclusion criteria (5 listed)
- refusal to participate
- private about freedom
- under guardianship
- under justice
- minor or major person unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample (act specific of blood withdrawal for the study)Specific intervention : blood sample (3x7 ml in total) | Procedure or surgery | Individuals sources, Recently infected subjects |
Primary outcome
HCV serological markers
Time frame: up to 30 months
Immunoblot analysis from blood samples collected during the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample (act specific of blood withdrawal for the study) in people with Hepatitis C, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV serological markers (time frame: up to 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.