National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

ANRS, Emerging Infectious Diseases800 enrolled

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.

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 Type

OBSERVATIONAL

Enrollment

800

Conditions

Hepatitis D, Chronic Hepatitis B, Chronic

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (38)

Outcomes

Primary Outcomes

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

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

Central Contacts

COULIBALY Fatoumata

CONTACT

0144236110 fatoumata.coulibaly@anrs.fr

Claire FOUGEROU-LEURENT

CONTACT

claire.fougerou@chu-rennes.fr

Data from ClinicalTrials.gov

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CHU of Angers

Angers, France

RECRUITING

Centre Hospitalier de la région annécienne

Annecy, France

NOT_YET_RECRUITING

Avicenne Hospital - Hepatology

Bobigny, France

RECRUITING

Avicenne Hospital

Bobigny, France

RECRUITING

Haut Lévêque Hospital

Bordeaux, France

RECRUITING

Estaing Hospital

Clermont-Ferrand, France

RECRUITING

Beaujon Hospital

Clichy, France

RECRUITING

Centre Hospitalier Intercommunal

Créteil, France

RECRUITING

Henri Mondor Hospital

Créteil, France

RECRUITING

Bocage Hospital

Dijon, France

RECRUITING

...and 28 more locations

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)