Hepatitis C, ChronicERADIcATENCT05813691
Epidemiology of Occult Hepatitis C Virus Infection in Patients Born Before 1969 in the Hospital Setting: a Spontaneous Opportunistic Screening Initiative.
An observational study of Hepatitis C, Chronic and Hepatitis C, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
The goal of this monocentric prospective observational study is to evaluate the prevalence of unknown hepatitis C virus chronic infection in general population born before january 1st 1968 in Italy. Read more about this study
- Who is it for?
- Ages 54 to 120 years
- Conditions the study is for
- Hepatitis C, Chronic, Hepatitis C, Hepatitis
- What is being tested?
- Meridan Bioscience Point of Care test against HCV antibodies
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2023to 10 Apr 2025
- Phase
- Observational
- 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 54 to 120 years
- All sexes
- Adult, Older adult
Study population: Patients born before January 1st 1968 who lived in Italy referred to any departments of the Policlinico A. Gemelli
Who may be able to join
- Patients born before January 1st 1968 who lived in Italy referred to any departments of the Policlinico A. Gemelli
Who cannot join
- Patients born after january 1st 1968
- Known infection of hepatitis C virus
- Previous treatment against hepatitis C virus
About this study
The goal of this monocentric prospective observational study is to evaluate the prevalence of unknown hepatitis C virus chronic infection in general population born before january 1st 1968 in Italy.
The main questions it aims to answer are:
Read more
what is the prevalence of hepatits C virus infection in general population born before January 1st, 1968? What rare the characteristics of these patients compared to the general population? What is the prevalence of patients tested HCV positive who are referred to the Hepatology Outpatient Clinic for further evaluation? What is the prevalence of patients with HCV infection detected during the study and treated with direct antiviral agents during follow up?
Participants will be tested with a point of care screening test (Meridian, Bioscience) able to detect anti-HCV antibodies to detect the presence of antibodies against HCV.
- Conditions
- Hepatitis C, Chronic, Hepatitis C, Hepatitis
- Being tested
- Meridan Bioscience Point of Care test against HCV antibodies
- Keywords
- hepatitis C virus
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meridan Bioscience Point of Care test against HCV antibodiesDiagnostic test
Point of care evaluation of antibodies against HCV obtaining a drop of capillary blood via puncture of the fingertip. If antibodies were detected, HCV RNA assay will be performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of antibodies against hepatitis C virus in cohort population
Evaluation of prevalence of antibodies against HCV in patients referred to any department of Policlinico Gemelli born before January 1st 1968
Measured: 24 months
Secondary outcomes (3)
Characteristics of population
Measured: 24 months
Prevalence of patients with a confirmed chronic HCV infection who are referred to Hepatology Outpatient clinic
Measured: 24 months
Prevalence of patients with a confirmed chronic HCV infection who are treated with direct antiviral agents
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start10 Apr 2023 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion10 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ponziani Francesca Romana, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813691
- Sponsor's protocol ID
- 5494
- Acronym
- ERADIcATE
- Status last verified
- Apr 2023
- First submitted
- 2 Apr 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Occult Hepatitis C Virus Infection in Patients Born Before 1969 in the Hospital Setting: a Spontaneous Opportunistic Screening Initiative.
- ClinicalTrials.gov ID
- NCT05813691
- Acronym / sponsor ID
- ERADIcATE / 5494
- Conditions
- Hepatitis C, Chronic, Hepatitis C, Hepatitis
- Keywords
- hepatitis C virus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 10 Apr 2023 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 14 Apr 2023 (actual)
- 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 goal of this monocentric prospective observational study is to evaluate the prevalence of unknown hepatitis C virus chronic infection in general population born before january 1st 1968 in Italy.
The main questions it aims to answer are:
what is the prevalence of hepatits C virus infection in general population born before January 1st, 1968? What rare the characteristics of these patients compared to the general population? What is the prevalence of patients tested HCV positive who are referred to the Hepatology Outpatient Clinic for further evaluation? What is the prevalence of patients with HCV infection detected during the study and treated with direct antiviral agents during follow up?
Participants will be tested with a point of care screening test (Meridian, Bioscience) able to detect anti-HCV antibodies to detect the presence of antibodies against HCV.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 54 to 120 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients born before January 1st 1968 who lived in Italy referred to any departments of the Policlinico A. Gemelli
Key inclusion criteria (1 listed)
- Patients born before January 1st 1968 who lived in Italy referred to any departments of the Policlinico A. Gemelli
Key exclusion criteria (3 listed)
- Patients born after january 1st 1968
- Known infection of hepatitis C virus
- Previous treatment against hepatitis C virus
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 |
|---|---|---|
| Meridan Bioscience Point of Care test against HCV antibodiesPoint of care evaluation of antibodies against HCV obtaining a drop of capillary blood via puncture of the fingertip. If antibodies were detected, HCV RNA assay will be performed. | Diagnostic test | – |
Primary outcome
prevalence of antibodies against hepatitis C virus in cohort population
Time frame: 24 months
Evaluation of prevalence of antibodies against HCV in patients referred to any department of Policlinico Gemelli born before January 1st 1968
3 secondary outcomes
Characteristics of population
Time frame: 24 months
Prevalence of patients with a confirmed chronic HCV infection who are referred to Hepatology Outpatient clinic
Time frame: 24 months
Prevalence of patients with a confirmed chronic HCV infection who are treated with direct antiviral agents
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic and Hepatitis C, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
prevalence of antibodies against hepatitis C virus in cohort population (time frame: 24 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 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.