Screening for Chronic Hepatitis C Virus in Hospitalized Patients (DeViCHO)
Primary Purpose
Hepatitis C
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hepatitis C, serology
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis C
Eligibility Criteria
Inclusion Criteria:
- all in-patient patients and consenting to participate at the study.
Exclusion Criteria:
- Refusal to participate in the study
- Contraindication to a blood sample (Impossibility of a peripheral venous approach and any clinical condition that may indicate a venous sample)
- Minor patient
- Patient unable to express consent
Sites / Locations
- Hopital Saint Joseph
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients consenting
Arm Description
Outcomes
Primary Outcome Measures
Prevalence of hepatitis C through the different department of Saint Joseph Hospital
At every hospitalized patients the trial will be presented. the viral screening will be proposed for the purpose of treating patients who will be viremic
Secondary Outcome Measures
number of viremic patients with risk factors
Identify viremic patients enrolled with identified risk factors
number of viremic patients without risk factors
Identify viremic patients enrolled without identified risk factors
number of patients who refuse viral screening
study will be presented to all hospitalized patients in Saint Joseph Hospital but investigators will estimate pateints who refuse to participate
Full Information
NCT ID
NCT04437277
First Posted
January 6, 2020
Last Updated
January 10, 2022
Sponsor
Hospital St. Joseph, Marseille, France
1. Study Identification
Unique Protocol Identification Number
NCT04437277
Brief Title
Screening for Chronic Hepatitis C Virus in Hospitalized Patients
Acronym
DeViCHO
Official Title
Screening for Chronic Hepatitis C Virus in Hospitalized Patients at Saint Joseph Hospital in Marseille
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 22, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital St. Joseph, Marseille, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic viral hepatitis C is a public health problem and several management recommendations are available. According to the HAS, hepatitis C screening consists of a targeted screening of people at risk of infection by the virus, in particular to drug users, to people from countries with a high prevalence of the virus or who have received care in those countries, people transfused before 1992, or people who have been or have been imprisoned. Our study proposes to evaluate hepatitis C screening in consenting patients hospitalized in Saint Joseph. These previously identified patients with comorbidities will be cared for according to current national practices that reduce HCV morbidity and mortality.
Detailed Description
Hepatitis C screening is based on a blood test, in particular the Elisa test, which looks for anti-HCV antibodies. In the case of positive C viral serology, the search for the C virus from a blood test makes it possible to detect the genome (RNA) of the virus, which is thus directly detected by a so-called "PCR" technique. Although screening activity is important in France, it remains insufficient. In December 2016, HAS concluded that risk-based targeted screening has limitations and contributes to the persistence of a hidden epidemic of viral C infection. It is estimated that 75,000 people are unaware of being carriers of the hepatitis C virus. However, there is safe, effective and well-tolerated treatment. With duration of 8 to 12 weeks it allows a healing of HCV in more than 95% of subjects. AFEF recommendations aim to achieve viral elimination C (as early as 2025). This elimination is defined as a 90% decrease in new infections associated with a 65% reduction in HCV mortality. OMS has planned this target for 2030. To achieve this goal, a number of measures are gradually being implemented focusing on universal treatment and universal screening. The hospital may be a place where systematic screening is interesting. In 2017, the prevalence of anti-HCV positive antibodies in the facility, apart from the Hepato-Gastroenterology service, was 1.7%, more than twice the estimated prevalence in our general population. These data give a rationale for the realization of this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Monocentric interventional longitudinal risk and minimal constraint study, consenting and consecutive in-patients recruited within the hospital
Masking
None (Open Label)
Allocation
N/A
Enrollment
5000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients consenting
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Hepatitis C, serology
Other Intervention Name(s)
Hepatitis C, PCR
Intervention Description
Inclusion of patients in conventional hospitalization at Saint Joseph Hospital. Each consenting patient benefits from a screening HCV serology carried out during a biological sample indicated by his state of health. In the case of positive HCV serology, an additional sample will be taken in search of viral replication. All detectable HCV PCR patients will be admitted to hepatology consultation for assessment of liver status including non-invasive methods and possible treatment according to the conditions of the Marketing Authorization and recommendations for routine clinical practice. Data on management (treatment or non-treatment and treatment outcome: prolonged virological response 12 weeks after completion of treatment) will be collected.
Primary Outcome Measure Information:
Title
Prevalence of hepatitis C through the different department of Saint Joseph Hospital
Description
At every hospitalized patients the trial will be presented. the viral screening will be proposed for the purpose of treating patients who will be viremic
Time Frame
one day
Secondary Outcome Measure Information:
Title
number of viremic patients with risk factors
Description
Identify viremic patients enrolled with identified risk factors
Time Frame
one day
Title
number of viremic patients without risk factors
Description
Identify viremic patients enrolled without identified risk factors
Time Frame
one day
Title
number of patients who refuse viral screening
Description
study will be presented to all hospitalized patients in Saint Joseph Hospital but investigators will estimate pateints who refuse to participate
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all in-patient patients and consenting to participate at the study.
Exclusion Criteria:
Refusal to participate in the study
Contraindication to a blood sample (Impossibility of a peripheral venous approach and any clinical condition that may indicate a venous sample)
Minor patient
Patient unable to express consent
Facility Information:
Facility Name
Hopital Saint Joseph
City
Marseille
State/Province
Paca
ZIP/Postal Code
13008
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Screening for Chronic Hepatitis C Virus in Hospitalized Patients
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