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Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients (HOSPI-VHC)

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ClinicalTrials.gov Identifier: NCT04405024
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Brief 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.


Condition or disease Intervention/treatment Phase
Hepatitis C Diagnostic Test: Hepatitis C testing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of the Feasibility of Routine Inpatient Hepatitis C Screening
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Hepatitis C testing

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.

Diagnostic Test: Hepatitis C testing
Hepatitis C Screening




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. HCV positive [ Time Frame: 7 days ]
    Percentage positive for HCV

  2. Follow-up [ Time Frame: 2 months ]
    Percentage of patients referred for consultation if HCV positive

  3. Polymerase chain reaction (PCR) [ Time Frame: 7 days ]
    Percentage of HCV PCR positive patients

  4. Viral risk factor [ Time Frame: 7 days ]
    Percentage of patients with a viral risk factor

  5. hepatic fibrosis [ Time Frame: 7 days ]
    Percentage of patients with hepatic fibrosis

  6. treatment initiation [ Time Frame: 2 months ]
    Percentage of patients benefiting from treatment initiation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient over 18 years of age
  • Hospitalized during the study period
  • Non-opposition for participation in the Protocol

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405024


Contacts
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Contact: Isabelle Rosa, PhD 01 45 17 50 00 ext +33 isabelle.rosa@chicreteil.fr
Contact: Camille JUNG 01 45 17 50 00 ext +33 camille.jung@chicreteil.fr

Locations
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France
CHI Créteil Recruiting
Créteil, France, 94000
Contact: Isabelle Rosa       isabelle.rosa@chicreteil.fr   
Grand Hôpital de l'Est Francilien - Site de Marne-la-Vallée Recruiting
Jossigny, France
Contact: Gilles MACAIGNE       gmacaigne@ghef.fr   
CH Meaux Recruiting
Meaux, France
Contact: Hatem SALLOUM       hatemsalloum@yahoo.fr   
CHIV Recruiting
Villeneuve-Saint-Georges, France
Contact: Armand GARIOUD       Armand.Garioud@chiv.fr   
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux
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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT04405024    
Other Study ID Numbers: HOSPI-VHC
2019-A03309-48 ( Other Identifier: ID-RCB )
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections