DELTA DESCRIBE: the French Collaborative Project (DELTADESCRIBE)

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis D
• Intervention / Treatment: Diagnostic test: Patients co-infected HBV/HDV

Detailed Description

Hepatitis Delta virus (HDV) infection is a significant public health disease causing up to 18% of cirrhosis and 20% of hepatocellular carcinoma (HCC) and new therapeutic options are now available. In France, very few epidemiological studies, mainly focused on specific pre-selected hospital populations, are available. There is a crucial need for data in terms of Delta knowledge, suitability of screening, type of prescribers and treatment access. The investigator proposes a retrospective study in order to describe the number of HDV tests (anti-HDV and HDV RNA) performed in metropolitan France and compare it to the potentially expected one, estimated from the number of HBV screening tests performed in one year, from 2016 to 2020. The investigator will also evaluate the number of HCV and HIV screening tests prescribed over the same period and the HDV PCR techniques used. This study will be based on one hand on data from the French Health insurance (first step) and on the other hand on data from private and hospital laboratories (second step). The second step will allow to identify the prescriber of the Delta tests and the HDV positive patients and precise their profile and their medical care. After an initial analysis of the results, The investigator will propose solutions to the barriers encountered and adapted to the identified targets.

• Study Type: Observational
• Enrollment (Estimated): 734

Contacts and Locations

• Study Contact: Name: Sandra Juge; Phone Number: 33 0555056414; Email: Sandra.Juge@chu-limoges.fr
• Study Contact Backup: Name: Céline Rigaud; Email: celine.rigaud@chu-limoges.fr

Study Locations

• France
  • Limoges, France, 87042
    • Recruiting
    • CHU Limoges
    • Contact: Sandra Juge; Phone Number: 33 0555056414; Email: Sandra.Juge@chu-limoges.fr
    • Principal Investigator: Véronique LOUSTAUD-RATTI, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of anti-HCV, anti-HIV and HBs Ag tests performed in metropolitan France from 2016 to 2020	Number of anti-HCV, anti-HIV and HBs Ag performed in France from 2016 to 2020 (SNDS data).	12 months
Age, sex, residence department and profile of prescribers of patients receiving HDV, HBV, HIV and HCV tests	Global epidemiological characteristics (age, sex, residence department), of patients receiving HDV, HBV, HIV and HCV tests on the 2016-2020 period, with the profile of prescribers. (SNDS data).	12 months
Number of anti-HDV and HDV RNA tests performed in 2019 by the laboratories in metropolitan France	Number and result of anti-HDV and HDV RNA tests performed in 2019 (Private and Public laboratories data	12 months
Age, sex, profile of the prescribers of HDV RNA positive patients identified by the laboratories in 2019	Age, sex, profile of the prescribers, treatment modalities (if available) of HDV RNA positive patients identified at the second step (Private and Public laboratories data)	12 months
Rate of use of the different HDV PCR techniques by the laboratories in 2019	HDV PCR techniques used (Private and Public laboratories data)	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: Véronique Loustaud-Ratti, Pr, University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Estimated): June 22, 2025
• Study Completion (Estimated): June 22, 2025

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 24, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Screening; HBs Ag; Delta hepatitis; Reflex testing
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepatitis; Hepatitis D
• Other Study ID Numbers: 87RI21_0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No