Clinical trial NCT04166266: National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses
Official title: National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis D, Chronic
Hepatitis B, Chronic
Keywords: safety
efficacy
evolution
treatment
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2019-11-18
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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

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.

Primary outcomes:
measure: To study the natural or treated history of patients infected with HDV according to different management modalities.
timeFrame: At the end of the follow-up, december 2027
Secondary outcomes:
measure: Number of patient's reported outcomes measured with specific questionnaire
timeFrame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
measure: Quality of observance measured with specific questionnaire
timeFrame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
measure: Alcohol consumption (AUDIT-c), tobacco and cannabis use
timeFrame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
measure: Socio-economic situation measured with specific questionnaire
timeFrame: weeks 24, 48, end of treatment and 48 weeks after the end of treatment
measure: Quality of life level measured with short-form 12 (SF12) questionnaire
timeFrame: At weeks 24, 48, end of treatment and 48 weeks after the end of treatment
measure: Rate of patients achieving HBV DNA indetectability
timeFrame: 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)
measure: Rate of early discontinuation of treatment due to an adverse event
timeFrame: At weeks 12, 24, 48, end of treatment
measure: HDV RNA level
timeFrame: 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)
measure: HDV RNA variation rate
timeFrame: 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)
measure: Breakthrough rate
timeFrame: At weeks 8, 12 and through the end of treatment (average 3 years)
measure: Rate of sustained virological response
timeFrame: At weeks 12, 24, 36 and 48 and through the end of treatment (average 3 years)
measure: Rate of partial virological response
timeFrame: At weeks 4, 8, 12 and through the end of treatment (average 3 years)
measure: Rate of patients achieving HBs seroconversion
timeFrame: 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)
measure: Virological response delay
timeFrame: At weeks 8, 12 and through the end of treatment (average 3 years)
measure: Number of different HDV resistance variants
timeFrame: Through treatment period, average 3 years
measure: Number of patients with at least one resistance variant
timeFrame: Through treatment period, average 3 years
measure: Fibrosis level
timeFrame: 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)
measure: Rate of adverse event
timeFrame: 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)
measure: Death rate
timeFrame: 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)
measure: Liver transplantation rate
timeFrame: 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)
measure: Number and characterization of associated treatment with analogs and/or interferon
timeFrame: At weeks 4, 8, 12 and through the end of treatment (average 3 years
measure: Rate of patients presenting an evolution towards hepatocellular carcinoma
timeFrame: 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)
measure: Rate of patients presenting an evolution towards cirrhosis
timeFrame: 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)
measure: Rate of patients presenting a decompensated cirrhosis
timeFrame: 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)
measure: Change in HBs Ag from baseline
timeFrame: 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)
measure: Rate of biochemical response
timeFrame: 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)
measure: Rate of patients achieving hepatitis B e (HBe) Ag negativation in patient initially HBeAg- positive
timeFrame: 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)
measure: Rate of patients with appearance of anti-HBe Ab
timeFrame: 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)
measure: Rate of patients achieving HBe seroconversion
timeFrame: 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)
measure: Rate of spontaneous virological recovery
timeFrame: 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)
measure: Rate of patients achieving HBs Ag negativation
timeFrame: 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)
measure: Rate of patients with appearance of anti-HBs Ab
timeFrame: 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)
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU of Angers
city: Annecy
country: France
facility: Centre Hospitalier de la région annécienne
city: Bobigny
country: France
facility: Avicenne Hospital - Hepatology
city: Bobigny
country: France
facility: Avicenne Hospital
city: Bordeaux
country: France
facility: Haut Lévêque Hospital
city: Clermont-Ferrand
country: France
facility: Estaing Hospital
city: Clichy
country: France
facility: Beaujon Hospital
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal
city: Créteil
country: France
facility: Henri Mondor Hospital
city: Dijon
country: France
facility: Bocage Hospital
city: Grenoble
country: France
facility: Michallon Hospital
city: Lille
country: France
facility: Claude Huriez Hospital
city: Limoges
country: France
facility: Dupuytren Hospital
city: Lyon
country: France
facility: Croix Rousse Hospital
city: Lyon
country: France
facility: Edouard Herriot Hospital
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Marseille
country: France
facility: SAint Joseph Hospital
city: Montpellier
country: France
facility: Saint Eloi Hospital
city: Nantes
country: France
facility: Hotel Dieu Hospital
city: Nantes
country: France
facility: Hôtel-Dieu Hospital
city: Nice
country: France
facility: l'Archet 2 Hospital
city: Orléans
country: France
facility: La Source Hospital
city: Paris
country: France
facility: Bichat-Claude Bernard Hospital
city: Paris
country: France
facility: Cochin Hospital
city: Paris
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: La Pitié Salpêtrière Hospital
city: Paris
country: France
facility: Lariboisière Hospital
city: Paris
country: France
facility: Pitié-Salpêtrière Hospital
city: Paris
country: France
facility: Saint Antoine Hospital
city: Paris
country: France
facility: Saint Louis Hospital
city: Paris
country: France
facility: Saint-Antoine Hospital
city: Rennes
country: France
facility: Pontchaillou Hospital
city: Rouen
country: France
facility: Charles Nicolle Hospital
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil
city: Toulouse
country: France
facility: Hôpital Rangueil
city: Toulouse
country: France
facility: Rangueil Hospital
city: Tours
country: France
facility: Trousseau Hospital
city: Villejuif
country: France
facility: Paul Brousse Hospital
Study officials:
affiliation: Hôpital de la Croix-Rousse
name: Fabien ZOULIM
role: STUDY_DIRECTOR
References: