DELTA DESCRIBE: the French Collaborative Project

NCT05936073 | Recruiting

• 1 other identifier: 87RI21_0068
• Study Type: observational
• Target: 734
• Locations: 1 country
• Sites: 1

Brief Summary

Our global objective is to draw up a photograph of HDV patients over one year in metropolitan France and identify the barriers of screening and care. The investigator suspects a mismatch between HBV and HDV screening, the first step for specialized care pathway in metropolitan France.

Conditions

Hepatitis D

Keywords

HBs Ag; Delta hepatitis; Screening; Reflex testing

Outcome Measures

Primary Outcomes (2)

• Number of anti-HDV and HDV RNA tests performed from 2016 to 2020 in metropolitan France

  \- Number of anti-HDV and HDV RNA tests performed from 2016 to 2020 in metropolitan France according to the French Health insurance database.(SNDS)

  12 months

• Number of anti-HDV and HDV RNA tests expected

  \- Number of anti-HDV and HDV RNA tests expected over the same period (calculated from the estimate of the positivity of HBsAg tests prescribed in France)

  12 months

Secondary Outcomes (5)

• Number of anti-HCV, anti-HIV and HBs Ag tests performed in metropolitan France from 2016 to 2020

  12 months

• Age, sex, residence department and profile of prescribers of patients receiving HDV, HBV, HIV and HCV tests

  12 months

• Number of anti-HDV and HDV RNA tests performed in 2019 by the laboratories in metropolitan France

  12 months

• Age, sex, profile of the prescribers of HDV RNA positive patients identified by the laboratories in 2019

  12 months

• Rate of use of the different HDV PCR techniques by the laboratories in 2019

  12 months

Interventions

Patients co-infected HBV/HDV DIAGNOSTIC_TEST

Step 1: collection of SNDS data from 2016 to 2020 Snapshot of the prescription of the Delta tests and the tests usually prescribed simultaneously (HBV but also HIV and HCV) in one year. The investigator will collect the number of tests performed once for a given patient: anti-HDV, HDV RNA, HBsAg, anti-HCV, anti-HIV, and for each test, the description of the profile and the geographical distribution of prescribers in the metropolitan area; the description of age and sex of the patients screened. Step 2: collection of anti-HDV and RNA tests performed in French private and Public laboratories over the year 2019 Anti-HDV and HDV RNA are subcontracted by most private laboratories to two specialized biology companies. Number of HDV tests prescribed, technique used, number of positive tests and name of the requesting laboratory will be collected. The investigator will then go back to the prescriber of the positive tests, identify the patient, his epidemiological profile and his medical care.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients (\>18 years) chronically infected by HBV and HDV (RNA HDV positive) at the second step

You may qualify if:

• \>18 years at the second step
• HDV RNA positive patients identified at the second step
• Patients non opposed to the collection of their data

You may not qualify if:

• Opposition expressed by the patients for the collection of their data

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Chu Limoges

Limoges, 87042, France

RECRUITING

MeSH Terms

Conditions

Hepatitis D; Hepatitis B

Condition Hierarchy (Ancestors)

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

Study Officials

• Véronique Loustaud-Ratti, Pr

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Juge

CONTACT

0555056414; Sandra.Juge@chu-limoges.fr

Céline Rigaud

CONTACT

celine.rigaud@chu-limoges.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 7, 2023
• Study Start: January 22, 2024
• Primary Completion: June 22, 2025
• Study Completion: June 22, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)