Hepatitis D, ChronicHEPDELTANCT04166266
National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses
An observational study of Hepatitis D, Chronic and Hepatitis B, Chronic, run by ANRS, Emerging Infectious Diseases at 38 sites in France.
Trial summary
This is a multicentre observational study with prospective and retrospective data collection and retrospective data collection and biological collection from patients with HBV/HDV co-infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis D, Chronic, Hepatitis B, Chronic
- What is being tested?
- Blood draw for the laboratory assessment
- How many people
- 800 participants
- Where
- 38 sitesFrance
- Study dates
- 19 Feb 2020to 30 Jun 2028
- How long will I take part?
- 7 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients followed in the participating centers for their HBV/HDV co-infection are susceptible to be included. Patients who already started a specific treatment for their HDV infection will be included retrospectively, after they have signed an informed consent.
Who may be able to join
- Age > 18 years,
- Presenting a chronic HDV infection (positive serology),
- Who gave his written informed consent before any intervention and the day of inclusion at the latest,
- Affiliated to Health Insurance or to the "Aide Médicale d'Etat" (request for exemption pending).
Who cannot join
- Patient participating in another biomedical research with an exclusion period ongoing at inclusion,
- Vulnerable patient (minor, adults legally protected: under judicial protection, guardianship, or supervision, persons deprived of their liberty).
- Patients with predictable difficulties of follow-up according to the investigator.
Trial locations and contacts
38 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Claire FOUGEROU-LEURENT contact
38 sites in 1 country
France38 sites, 38 recruiting
- Recruiting
CHU of Angers
Angers
Isabelle FOUCHARD
- Not yet recruiting
Centre Hospitalier de la région annécienne
Annecy
Frederic HELUWAERT
- Recruiting
Avicenne Hospital - Hepatology
Bobigny
Dominique ROULOT
- Recruiting
Avicenne Hospital
Bobigny
Nathalie GANNE
- Recruiting
Haut Lévêque Hospital
Bordeaux
Juliette FOUCHER
- Recruiting
Estaing Hospital
Clermont-Ferrand
Armand ABERGEL
- Recruiting
Beaujon Hospital
Clichy
Tarik ASSELAH
- Recruiting
Centre Hospitalier Intercommunal
Créteil
Isabelle ROSA
- Recruiting
Henri Mondor Hospital
Créteil
Vincent LEROY
- Recruiting
Bocage Hospital
Dijon
Anne MINELLO
- Recruiting
Michallon Hospital
Grenoble
Marie-Noëlle HILLERET
- Recruiting
Claude Huriez Hospital
Lille
Philippe MATHURIN
- Recruiting
Dupuytren Hospital
Limoges
Véronique LOUSTAUD-RATTI
- Recruiting
Croix Rousse Hospital
Lyon
Dulce ALFAIATE
- Recruiting
Edouard Herriot Hospital
Lyon
Jérôme DUMORTIER
- Recruiting
Hôpital de la Croix Rousse
Lyon
Fabien ZOULIM
- Recruiting
SAint Joseph Hospital
Marseille
Marc BOURLIERE
- Recruiting
Saint Eloi Hospital
Montpellier
Magdalena MESZAROS
- Recruiting
Hotel Dieu Hospital
Nantes
Jérôme GOURNAY
- Recruiting
Hôtel-Dieu Hospital
Nantes
François RAFFI
- Recruiting
l'Archet 2 Hospital
Nice
Albert TRAN
- Recruiting
La Source Hospital
Orléans
Xavier CAUSSE
- Recruiting
Bichat-Claude Bernard Hospital
Paris
Anne GERVAIS
- Recruiting
Cochin Hospital
Paris
Stanislas POL
- Recruiting
Hôpital Tenon
Paris
Julie CHAS
- Recruiting
La Pitié Salpêtrière Hospital
Paris
Vlad RATZIU
- Not yet recruiting
Lariboisière Hospital
Paris
Myriam DIEMER
- Recruiting
Pitié-Salpêtrière Hospital
Paris
Marc-Antoine VALANTIN
- Recruiting
Saint Antoine Hospital
Paris
Olivier CHAZOUILLERES
- Recruiting
Saint Louis Hospital
Paris
Caroline LASCOUX-COMBE
- Recruiting
Saint-Antoine Hospital
Paris
Karine LACOMBE
- Recruiting
Pontchaillou Hospital
Rennes
Caroline JEZEQUEL
- Recruiting
Charles Nicolle Hospital
Rouen
Ghassan RIACHI
- Recruiting
Nouvel Hôpital Civil
Strasbourg
Simona TRIPON
- Recruiting
Hôpital Rangueil
Toulouse
Laurent ALRIC
- Recruiting
Rangueil Hospital
Toulouse
Sophie METIVIER
- Recruiting
Trousseau Hospital
Tours
Louis d'ALTEROCHE
- Recruiting
Paul Brousse Hospital
Villejuif
Bruno ROCHE
About this study
This is a multicentre observational study with prospective and retrospective data collection and retrospective data collection and biological collection from patients with HBV/HDV co-infection.
Read the detailed description
This is an observatory for patients co-infected with hepatitis B and Delta viruses. Patients will be monitored according to the usual recommendations, depending on their status:
- Patients who have never received specific treatment for hepatitis Delta (untreated or receiving treatment with peginterferon alpha 2a alone) will be monitored according to current recommendations, once every 6 months;
- Patients treated or having been treated with a specific hepatitis Delta treatment will be monitored according to the compassionate access protocol or according to the recommendations of the AMM during treatment and according to routine follow-up after the end of treatment.
Participation in research entails the following additional procedures for patients, for each line of treatment, where applicable:
- Samples for the biobank,
- Self-administered questionnaires.
In addition, as sub-studies are planned on sub-groups of patients, these sub-studies may involve additional constraints/interventions
- Conditions
- Hepatitis D, Chronic, Hepatitis B, Chronic
- Being tested
- Blood draw for the laboratory assessment
- Keywords
- safety, efficacy, evolution, treatment
- Medical subject headings
- Hepatitis D, Chronic, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw for the laboratory assessmentOther
Blood sampling for the biobank and, in addition, as sub-studies are planned on sub-groups of patients, additional blood samples are planned for the patients in these sub-studies.
| Study group | Role | What they receive |
|---|---|---|
| Adults with co-infection with hepatitis B and Delta viruses, | Blood sampling for the biobank and, in addition, as sub-studies are planned on sub-groups of patients, additional blood samples are planned for the patients in these sub-studies. Receives: Other: Blood draw for the laboratory assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the natural or treated history of patients infected with HDV according to different management modalities.
This is a cohort in which many events will be studied. As the objectives are multiple, no primary endpoint has been defined.
Measured: At the end of the follow-up, december 2027
Secondary outcomes (32)
Number of patient's reported outcomes measured with specific questionnaire
Measured: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Quality of observance measured with specific questionnaire
Measured: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Alcohol consumption (AUDIT-c), tobacco and cannabis use
Measured: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Socio-economic situation measured with specific questionnaire
Measured: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Quality of life level measured with short-form 12 (SF12) questionnaire
Measured: At weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Rate of patients achieving HBV DNA indetectability
Measured: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of early discontinuation of treatment due to an adverse event
Measured: At weeks 12, 24, 48, end of treatment
HDV RNA level
Measured: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
HDV RNA variation rate
Measured: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Breakthrough rate
Measured: At weeks 8, 12 and through the end of treatment (average 3 years)
Rate of sustained virological response
HDV RNA undetectability
Measured: At weeks 12, 24, 36 and 48 and through the end of treatment (average 3 years)
Rate of partial virological response
reduction in Delta RNA of at least 2 log10 compared with the basal value, without undetectability
Measured: At weeks 4, 8, 12 and through the end of treatment (average 3 years)
Rate of patients achieving HBs seroconversion
Measured: At weeks 12, 24, 48,through the end of treatment (average 3 years), and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Virological response delay
Measured: At weeks 8, 12 and through the end of treatment (average 3 years)
Number of different HDV resistance variants
Measured: Through treatment period, average 3 years
Number of patients with at least one resistance variant
Measured: Through treatment period, average 3 years
Fibrosis level
Measured: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of adverse event
Measured: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Death rate
Measured: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Liver transplantation rate
Measured: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Number and characterization of associated treatment with analogs and/or interferon
Measured: At weeks 4, 8, 12 and through the end of treatment (average 3 years
Rate of patients presenting an evolution towards hepatocellular carcinoma
Measured: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients presenting an evolution towards cirrhosis
in non-cirrhotic patients
Measured: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients presenting a decompensated cirrhosis
in non-cirrhotic patients
Measured: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Change in HBs Ag from baseline
Measured: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of biochemical response
Biochemical response is defined as ALT and aspartate aminotransferase (AST) normalization
Measured: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients achieving hepatitis B e (HBe) Ag negativation in patient initially HBeAg- positive
Measured: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients with appearance of anti-HBe Ab
Measured: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients achieving HBe seroconversion
Measured: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of spontaneous virological recovery
Prolonged HDV RNA undetectability
Measured: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients achieving HBs Ag negativation
Measured: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients with appearance of anti-HBs Ab
Measured: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start19 Feb 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis D, ChronicStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 800 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Fabien ZOULIM, Study director, Hôpital de la Croix-Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166266
- Sponsor's protocol ID
- ANRS HD EP01-HEPDELTA
- Acronym
- HEPDELTA
- Status last verified
- Aug 2024
- First submitted
- 12 Sep 2019
- Last updated
- 5 Feb 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 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses
- ClinicalTrials.gov ID
- NCT04166266
- Acronym / sponsor ID
- HEPDELTA / ANRS HD EP01-HEPDELTA
- Conditions
- Hepatitis D, Chronic, Hepatitis B, Chronic
- Keywords
- safety, efficacy, evolution, treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 18 Nov 2019 (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.
This is a multicentre observational study with prospective and retrospective data collection and retrospective data collection and biological collection from patients with HBV/HDV co-infection.
Detailed description
This is an observatory for patients co-infected with hepatitis B and Delta viruses. Patients will be monitored according to the usual recommendations, depending on their status:
- Patients who have never received specific treatment for hepatitis Delta (untreated or receiving treatment with peginterferon alpha 2a alone) will be monitored according to current recommendations, once every 6 months;
- Patients treated or having been treated with a specific hepatitis Delta treatment will be monitored according to the compassionate access protocol or according to the recommendations of the AMM during treatment and according to routine follow-up after the end of treatment.
Participation in research entails the following additional procedures for patients, for each line of treatment, where applicable:
- Samples for the biobank,
- Self-administered questionnaires.
In addition, as sub-studies are planned on sub-groups of patients, these sub-studies may involve additional constraints/interventions
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 7 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with co-infection with hepatitis B and Delta viruses, | – | Other: Blood draw for the laboratory assessmentBlood sampling for the biobank and, in addition, as sub-studies are planned on sub-groups of patients, additional blood samples are planned for the patients in these sub-studies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients followed in the participating centers for their HBV/HDV co-infection are susceptible to be included. Patients who already started a specific treatment for their HDV infection will be included retrospectively, after they have signed an informed consent.
Key inclusion criteria (4 listed)
- Age > 18 years,
- Presenting a chronic HDV infection (positive serology),
- Who gave his written informed consent before any intervention and the day of inclusion at the latest,
- Affiliated to Health Insurance or to the "Aide Médicale d'Etat" (request for exemption pending).
Key exclusion criteria (3 listed)
- Patient participating in another biomedical research with an exclusion period ongoing at inclusion,
- Vulnerable patient (minor, adults legally protected: under judicial protection, guardianship, or supervision, persons deprived of their liberty).
- Patients with predictable difficulties of follow-up according to the investigator.
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 |
|---|---|---|
| Blood draw for the laboratory assessmentBlood sampling for the biobank and, in addition, as sub-studies are planned on sub-groups of patients, additional blood samples are planned for the patients in these sub-studies. | Other | Adults with co-infection with hepatitis B and Delta viruses, |
Primary outcome
To study the natural or treated history of patients infected with HDV according to different management modalities.
Time frame: At the end of the follow-up, december 2027
This is a cohort in which many events will be studied. As the objectives are multiple, no primary endpoint has been defined.
32 secondary outcomes
Number of patient's reported outcomes measured with specific questionnaire
Time frame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Quality of observance measured with specific questionnaire
Time frame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Alcohol consumption (AUDIT-c), tobacco and cannabis use
Time frame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Socio-economic situation measured with specific questionnaire
Time frame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Quality of life level measured with short-form 12 (SF12) questionnaire
Time frame: At weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Rate of patients achieving HBV DNA indetectability
Time frame: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of early discontinuation of treatment due to an adverse event
Time frame: At weeks 12, 24, 48, end of treatment
HDV RNA level
Time frame: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
HDV RNA variation rate
Time frame: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Breakthrough rate
Time frame: At weeks 8, 12 and through the end of treatment (average 3 years)
Rate of sustained virological response
Time frame: At weeks 12, 24, 36 and 48 and through the end of treatment (average 3 years)
Rate of partial virological response
Time frame: At weeks 4, 8, 12 and through the end of treatment (average 3 years)
Rate of patients achieving HBs seroconversion
Time frame: At weeks 12, 24, 48,through the end of treatment (average 3 years), and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Virological response delay
Time frame: At weeks 8, 12 and through the end of treatment (average 3 years)
Number of different HDV resistance variants
Time frame: Through treatment period, average 3 years
Number of patients with at least one resistance variant
Time frame: Through treatment period, average 3 years
Fibrosis level
Time frame: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of adverse event
Time frame: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Death rate
Time frame: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Liver transplantation rate
Time frame: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Number and characterization of associated treatment with analogs and/or interferon
Time frame: At weeks 4, 8, 12 and through the end of treatment (average 3 years
Rate of patients presenting an evolution towards hepatocellular carcinoma
Time frame: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients presenting an evolution towards cirrhosis
Time frame: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients presenting a decompensated cirrhosis
Time frame: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Change in HBs Ag from baseline
Time frame: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of biochemical response
Time frame: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients achieving hepatitis B e (HBe) Ag negativation in patient initially HBeAg- positive
Time frame: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients with appearance of anti-HBe Ab
Time frame: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients achieving HBe seroconversion
Time frame: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of spontaneous virological recovery
Time frame: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients achieving HBs Ag negativation
Time frame: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
Rate of patients with appearance of anti-HBs Ab
Time frame: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)
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 5 Feb 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.
Claire FOUGEROU-LEURENT contact
Fabien ZOULIM study director
Hôpital de la Croix-Rousse
38 sites 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, Chronic and Hepatitis B, Chronic, run by ANRS, Emerging Infectious Diseases at 38 sites 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 4 inclusion and 3 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 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites 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 COULIBALY Fatoumata (0144236110 ext. +33, fatoumata.coulibaly@anrs.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the natural or treated history of patients infected with HDV according to different management modalities. (time frame: At the end of the follow-up, december 2027). 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 5 Feb 2025.