Health TrialsbyHealthPanel

DELTA DESCRIBE: the French Collaborative Project

ConditionHepatitis D
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Limoges

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>18 years at the second step

HDV RNA positive patients identified at the second step

Patients non opposed to the collection of their data

Disqualifiers

Opposition expressed by the patients for the collection of their data

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Limoges

Lead sponsor

Source ClinicalTrials.gov
Apply now