An observational study in Hepatitis D, Chronic and Hepatitis B, Chronic, sponsored by ANRS, Emerging Infectious Diseases. Recruiting at 38 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by ANRS, Emerging Infectious Diseases · Observational
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.
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:
Participation in research entails the following additional procedures for patients, for each line of treatment, where applicable:
In addition, as sub-studies are planned on sub-groups of patients, these sub-studies may involve additional constraints/interventions
43 studies on the registry are indexed under Hepatitis D, Chronic; 9 are open to participants now.
This study's planned enrollment of 800 is above the median of 285 across 10 observational studies indexed under Hepatitis D, Chronic.
Browse Hepatitis D, Chronic studies →ANRS, Emerging Infectious Diseases is the lead sponsor of 215 studies on the registry; 38 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Blood draw for the laboratory assessment
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.
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.
Time frame: At the end of the follow-up, december 2027
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
HDV RNA undetectability
Time frame: 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
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
in non-cirrhotic patients
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
in non-cirrhotic patients
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
Biochemical response is defined as ALT and aspartate aminotransferase (AST) normalization
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
Prolonged HDV RNA undetectability
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)
Plan to share: No
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