NCT04405024

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

September 21, 2020

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2020

Completed
Last Updated

September 15, 2026

Status Verified

September 1, 2026

Enrollment Period

8 days

First QC Date

May 22, 2020

Last Update Submit

September 11, 2026

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • potential patient versus

    Number of HCV serologies collected compared to the number of patients meeting the inclusion criteria during the study period.

    7 days

Secondary Outcomes (6)

  • HCV positive

    7 days

  • Follow-up

    2 months

  • Polymerase chain reaction (PCR)

    7 days

  • Viral risk factor

    7 days

  • hepatic fibrosis

    7 days

  • +1 more secondary outcomes

Study Arms (1)

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.

Diagnostic Test: Hepatitis C testing

Interventions

Hepatitis C testingDIAGNOSTIC_TEST

Hepatitis C Screening

Hepatitis C testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHI Créteil

Créteil, 94000, France

Location

Grand Hôpital de l'Est Francilien - Site de Marne-la-Vallée

Jossigny, France

Location

CH Meaux

Meaux, France

Location

CHIV

Villeneuve-Saint-Georges, France

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

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

Study Record Dates

First Submitted

May 22, 2020

First Posted

May 28, 2020

Study Start

September 21, 2020

Primary Completion

September 29, 2020

Study Completion

September 29, 2020

Last Updated

September 15, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)