An observational study in Hepatitis D, sponsored by University Hospital, Limoges. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by University Hospital, Limoges · Observational
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.
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.
63 studies on the registry are indexed under Hepatitis D; 21 are open to participants now.
This study's planned enrollment of 734 is above the median of 326 across 29 observational studies indexed under Hepatitis D.
Browse Hepatitis D studies →University Hospital, Limoges is the lead sponsor of 264 studies on the registry; 38 are open to participants now.
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Patients (>18 years) chronically infected by HBV and HDV (RNA HDV positive) at the second step
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Exclusion Criteria:
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.
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)
Time frame: 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)
Time frame: 12 months
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).
Time frame: 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).
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 12 months
Plan to share: No
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