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NCT Number: NCT05936073

DELTA DESCRIBE: the French Collaborative Project

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Limoges

Limoges, 87042, France

Location status: Recruiting

Location contact

Sandra Juge

CONTACT

[email protected]

0555056414 ext. 33

Véronique LOUSTAUD-RATTI, Pr

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 12 months

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

  2. Number of anti-HDV and HDV RNA tests expected

    Time frame: 12 months

    • 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)

Secondary outcomes

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

    Time frame: 12 months

    Number of anti-HCV, anti-HIV and HBs Ag performed in France from 2016 to 2020 (SNDS data).

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

    Time frame: 12 months

    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).

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

    Time frame: 12 months

    Number and result of anti-HDV and HDV RNA tests performed in 2019 (Private and Public laboratories data

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

    Time frame: 12 months

    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)

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

    Time frame: 12 months

    HDV PCR techniques used (Private and Public laboratories data)

Study contacts

Contact information is provided by the study sponsor or research team.

Céline Rigaud

CONTACT

[email protected]

Sandra Juge

CONTACT

[email protected]

0555056414 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: DELTADESCRIBE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2023
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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