National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood draw for the laboratory assessment.
- Who it may be relevant to
- Registry conditions: Hepatitis D, Chronic, Hepatitis B, Chronic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- 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.
Primary outcome measures
- 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]
Secondary outcome measures (12)
- 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)]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 38 centers
- CHU of Angers — Angers
- Centre Hospitalier de la région annécienne — Annecy
- Avicenne Hospital - Hepatology — Bobigny
- Avicenne Hospital — Bobigny
- Haut Lévêque Hospital — Bordeaux
- Estaing Hospital — Clermont-Ferrand
- Beaujon Hospital — Clichy
- Centre Hospitalier Intercommunal — Créteil
- … and 30 more centers
Identifiers
NCT: NCT04166266 · ANRS HD EP01-HEPDELTA