Hepatitis CHOSPI-VHCNCT04405024
Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients
A study testing Hepatitis C testing in people with Hepatitis C, run by Centre Hospitalier Intercommunal Creteil at 4 sites in France.
Trial summary
The Ministry of Health has set the target of eradicating hepatitis C (HCV) in France by 2025. The goal is to validate the feasibility and value of conducting routine HCV screening in hospitalized patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Hepatitis C testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 4 sitesFrance
- Study dates
- 21 Sep 2020to 29 Sep 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient over 18 years of age
- Hospitalized during the study period
- Non-opposition for participation in the Protocol
Who cannot join
- Patients under 18 years of age
- Outpatient, long-stay, maternity and intensive care inpatients
- Patients refusing blood collection
- Patient may not understand the information sheet
- Patient under guardianship
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHI Créteil
Créteil, 94000
Grand Hôpital de l'Est Francilien - Site de Marne-la-Vallée
Jossigny
CH Meaux
Meaux
CHIV
Villeneuve-Saint-Georges
About this study
Official title: Pilot Study of the Feasibility of Routine Inpatient Hepatitis C Screening
The Ministry of Health has set the target of eradicating hepatitis C (HCV) in France by 2025.
The goal is to validate the feasibility and value of conducting routine HCV screening in hospitalized patients.
Read the detailed description
The number of undetected HCV-infected persons has been extrapolated to 75,000 according to the results of a 2014 study. Screening efforts have been set up in groups of people said to be at high viral risk: drug users, prisoners, precarious persons or migrants from highly endemic countries. Nevertheless, the concept of universal screening has not yet been adopted by the guardians and the Ministry.
It is in this context that "hepatitis free hospital" projects have been carried out in several French cities such as Nice, Nancy and Marseille.
The aim of the HOSPI-VHC study is to evaluate the feasibility and efficiency of systematic HCV screening in all medical and surgical departments of 4 National Association of Hepato-Gastroenterologists of General Hospitals (ANGH) hospitals. This pilot project is part of a public health screening program. It will evaluate the interest and usefulness of implementing universal screening in hospitalized patients without taking into account the existence of viral risk factors. This study will also make it possible to evaluate the implementation of a dedicated care pathway: number of patients screened, number of patients referred for consultation and number of patients accepting the consultation.
- Conditions
- Hepatitis C
- Being tested
- Hepatitis C testing
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis C testingDiagnostic test
Hepatitis C Screening
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis C testing | Other | If the patient is included in the study, HCV serology (2 x 5 ml tubes) will be taken at the time of admission as part of the routine entry assessment.
These two tubes will be used for HCV screening. The patient is informed of the HCV serology result during hospitalization by an investigator. Receives: Diagnostic Test: Hepatitis C testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
potential patient versus
Number of HCV serologies collected compared to the number of patients meeting the inclusion criteria during the study period.
Measured: 7 days
Secondary outcomes (6)
HCV positive
Percentage positive for HCV
Measured: 7 days
Follow-up
Percentage of patients referred for consultation if HCV positive
Measured: 2 months
Polymerase chain reaction (PCR)
Percentage of HCV PCR positive patients
Measured: 7 days
Viral risk factor
Percentage of patients with a viral risk factor
Measured: 7 days
hepatic fibrosis
Percentage of patients with hepatic fibrosis
Measured: 7 days
treatment initiation
Percentage of patients benefiting from treatment initiation
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start21 Sep 2020
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
Why it stopped: The study was prematurely terminated due to major recruitment difficulties. Indeed, only one site was opened and participated in the study, with inclusions carried out in 2020.
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.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405024
- Sponsor's protocol ID
- HOSPI-VHC
- Other IDs
- 2019-A03309-48
- Acronym
- HOSPI-VHC
- Status last verified
- Sep 2026
- First submitted
- 22 May 2020
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Feasibility of Routine Inpatient Hepatitis C Screening
- ClinicalTrials.gov ID
- NCT04405024
- Acronym / sponsor ID
- HOSPI-VHC / HOSPI-VHC
- Conditions
- Hepatitis C
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely terminated due to major recruitment difficulties. Indeed, only one site was opened and participated in the study, with inclusions carried out in 2020.
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 28 May 2020 (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 Ministry of Health has set the target of eradicating hepatitis C (HCV) in France by 2025.
The goal is to validate the feasibility and value of conducting routine HCV screening in hospitalized patients.
Detailed description
The number of undetected HCV-infected persons has been extrapolated to 75,000 according to the results of a 2014 study. Screening efforts have been set up in groups of people said to be at high viral risk: drug users, prisoners, precarious persons or migrants from highly endemic countries. Nevertheless, the concept of universal screening has not yet been adopted by the guardians and the Ministry.
It is in this context that "hepatitis free hospital" projects have been carried out in several French cities such as Nice, Nancy and Marseille.
The aim of the HOSPI-VHC study is to evaluate the feasibility and efficiency of systematic HCV screening in all medical and surgical departments of 4 National Association of Hepato-Gastroenterologists of General Hospitals (ANGH) hospitals. This pilot project is part of a public health screening program. It will evaluate the interest and usefulness of implementing universal screening in hospitalized patients without taking into account the existence of viral risk factors. This study will also make it possible to evaluate the implementation of a dedicated care pathway: number of patients screened, number of patients referred for consultation and number of patients accepting the consultation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis C testing | Other | Diagnostic Test: Hepatitis C testingIf the patient is included in the study, HCV serology (2 x 5 ml tubes) will be taken at the time of admission as part of the routine entry assessment. These two tubes will be used for HCV screening. The patient is informed of the HCV serology result during hospitalization by an investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient over 18 years of age
- Hospitalized during the study period
- Non-opposition for participation in the Protocol
Key exclusion criteria (5 listed)
- Patients under 18 years of age
- Outpatient, long-stay, maternity and intensive care inpatients
- Patients refusing blood collection
- Patient may not understand the information sheet
- Patient under guardianship
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 |
|---|---|---|
| Hepatitis C testingHepatitis C Screening | Diagnostic test | Hepatitis C testing |
Primary outcome
potential patient versus
Time frame: 7 days
Number of HCV serologies collected compared to the number of patients meeting the inclusion criteria during the study period.
6 secondary outcomes
HCV positive
Time frame: 7 days
Follow-up
Time frame: 2 months
Polymerase chain reaction (PCR)
Time frame: 7 days
Viral risk factor
Time frame: 7 days
hepatic fibrosis
Time frame: 7 days
treatment initiation
Time frame: 2 months
Results and safety
The study was stopped early (reason given: The study was prematurely terminated due to major recruitment difficulties. Indeed, only one site was opened and participated in the study, with inclusions carried out in 2020.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatitis C testing in people with Hepatitis C, run by Centre Hospitalier Intercommunal Creteil at 4 sites 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 3 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: stopped early, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 was stopped early (reason given: The study was prematurely terminated due to major recruitment difficulties. Indeed, only one site was opened and participated in the study, with inclusions carried out in 2020.). 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?
potential patient versus (time frame: 7 days). 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 15 Sep 2026; AzTrials last refreshed its copy on 1 Nov 2026.