Screening for Chronic Hepatitis C Virus in Hospitalized Patients

NCT04437277 | Completed

• 1 other identifier: 2018-A02595-50
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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

  one day

Secondary Outcomes (3)

• number of viremic patients with risk factors

  one day

• number of viremic patients without risk factors

  one day

• number of patients who refuse viral screening

  one day

Study Arms (1)

Patients consenting

EXPERIMENTAL

Diagnostic Test: Hepatitis C, serology

Interventions

Hepatitis C, serology DIAGNOSTIC_TEST

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.

Also known as: Hepatitis C, PCR

Patients consenting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all in-patient patients and consenting to participate at the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital St. Joseph, Marseille, France: lead

Study Sites (1)

Hopital Saint Joseph

Marseille, PACA, 13008, France

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric interventional longitudinal risk and minimal constraint study, consenting and consecutive in-patients recruited within the hospital

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: June 18, 2020
• Study Start: November 22, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)