Hepatitis DDELTADESCRIBENCT05936073
DELTA DESCRIBE: the French Collaborative Project
An observational study of Hepatitis D, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis D
- What is being tested?
- Patients co-infected HBV/HDV
- How many people
- 734 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2024to 22 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients (>18 years) chronically infected by HBV and HDV (RNA HDV positive) at the second step
Who may be able to join
- >18 years at the second step
- HDV RNA positive patients identified at the second step
- Patients non opposed to the collection of their data
Who cannot join
- Opposition expressed by the patients for the collection of their data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Céline Rigaud contact
France1 site, 1 recruiting
- Recruiting
Chu Limoges
Limoges, 87042
Sandra Juge, 0555056414 ext. 33, Sandra.Juge@chu-limoges.fr
Véronique LOUSTAUD-RATTI, Pr
About this study
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.
Read the 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.
- Conditions
- Hepatitis D
- Being tested
- Patients co-infected HBV/HDV
- Keywords
- HBs Ag, Delta hepatitis, Screening, Reflex testing
- Medical subject headings
- Hepatitis D, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients co-infected HBV/HDVDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 12 months
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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
Measured: 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)
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start22 Jan 2024
- Primary completion22 Jun 2025 (estimated)
- Study completion22 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 734 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique Loustaud-Ratti, Pr, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936073
- Sponsor's protocol ID
- 87RI21_0068
- Acronym
- DELTADESCRIBE
- Status last verified
- May 2025
- First submitted
- 27 Jun 2023
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DELTA DESCRIBE: the French Collaborative Project
- ClinicalTrials.gov ID
- NCT05936073
- Acronym / sponsor ID
- DELTADESCRIBE / 87RI21_0068
- Conditions
- Hepatitis D
- Keywords
- HBs Ag, Delta hepatitis, Screening, Reflex testing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 734 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 22 Jun 2025 (estimated)
- Study completion
- 22 Jun 2025 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients (>18 years) chronically infected by HBV and HDV (RNA HDV positive) at the second step
Key inclusion criteria (3 listed)
- >18 years at the second step
- HDV RNA positive patients identified at the second step
- Patients non opposed to the collection of their data
Key exclusion criteria (1 listed)
- Opposition expressed by the patients for the collection of their data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients co-infected HBV/HDVStep 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. | Diagnostic test | – |
Primary outcome
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)
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)
5 secondary outcomes
Number of anti-HCV, anti-HIV and HBs Ag tests performed in metropolitan France from 2016 to 2020
Time frame: 12 months
Age, sex, residence department and profile of prescribers of patients receiving HDV, HBV, HIV and HCV tests
Time frame: 12 months
Number of anti-HDV and HDV RNA tests performed in 2019 by the laboratories in metropolitan France
Time frame: 12 months
Age, sex, profile of the prescribers of HDV RNA positive patients identified by the laboratories in 2019
Time frame: 12 months
Rate of use of the different HDV PCR techniques by the laboratories in 2019
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Céline Rigaud contact
Véronique Loustaud-Ratti, Pr principal investigator
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis D, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra Juge (0555056414 ext. 33, Sandra.Juge@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of anti-HDV and HDV RNA tests performed from 2016 to 2020 in metropolitan France (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.