Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Screening for Chronic Hepatitis C Virus in Hospitalized Patients (DeViCHO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04437277
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital St. Joseph, Marseille, France

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.

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Monocentric interventional longitudinal risk and minimal constraint study, consenting and consecutive in-patients recruited within the hospital
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Screening for Chronic Hepatitis C Virus in Hospitalized Patients at Saint Joseph Hospital in Marseille
Actual Study Start Date : November 29, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients consenting Diagnostic Test: Hepatitis C, serology
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.
Other Name: Hepatitis C, PCR




Primary Outcome Measures :
  1. Prevalence of hepatitis C through the different department of Saint Joseph Hospital [ Time Frame: one day ]
    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 :
  1. number of viremic patients with risk factors [ Time Frame: one day ]
    Identify viremic patients enrolled with identified risk factors

  2. number of viremic patients without risk factors [ Time Frame: one day ]
    Identify viremic patients enrolled without identified risk factors

  3. number of patients who refuse viral screening [ Time Frame: one day ]
    study will be presented to all hospitalized patients in Saint Joseph Hospital but investigators will estimate pateints who refuse to participate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04437277


Contacts
Layout table for location contacts
Contact: Laurence LECOMTE +33491808235 llecomte@hopital-saint-joseph.fr

Locations
Layout table for location information
France
Hopital Saint Joseph Recruiting
Marseille, Paca, France, 13008
Contact: Laurence LECOMTE    +33491808235    llecomte@hopital-saint-joseph.fr   
Principal Investigator: Marc BOURLIERE, MD         
Sub-Investigator: Si Nafa SI AHMED, MD         
Sub-Investigator: Souad BEN ALI, MD         
Sponsors and Collaborators
Hospital St. Joseph, Marseille, France
Layout table for additonal information
Responsible Party: Hospital St. Joseph, Marseille, France
ClinicalTrials.gov Identifier: NCT04437277    
Other Study ID Numbers: 2018-A02595-50
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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