National Cohort of Patients Co-infected with Hepatitis B and Delta Viruses
- Conditions
- Hepatitis B, ChronicHepatitis D, Chronic
- Registration Number
- NCT04166266
- Lead Sponsor
- ANRS, Emerging Infectious Diseases
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
- 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).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the natural or treated history of patients infected with HDV according to different management modalities. 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.
- Secondary Outcome Measures
Name Time Method Breakthrough rate At weeks 8, 12 and through the end of treatment (average 3 years) Rate of sustained virological response At weeks 12, 24, 36 and 48 and through the end of treatment (average 3 years) HDV RNA undetectability
Number of patient's reported outcomes measured with specific questionnaire weeks 24, 48, end of treatment and 48 weeks after the end of treatment Quality of observance measured with specific questionnaire weeks 24, 48, end of treatment and 48 weeks after the end of treatment Alcohol consumption (AUDIT-c), tobacco and cannabis use weeks 24, 48, end of treatment and 48 weeks after the end of treatment Socio-economic situation measured with specific questionnaire 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 At weeks 24, 48, end of treatment and 48 weeks after the end of treatment Rate of patients achieving HBV DNA indetectability 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 At weeks 12, 24, 48, end of treatment HDV RNA level 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 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 partial virological response At weeks 4, 8, 12 and through the end of treatment (average 3 years) reduction in Delta RNA of at least 2 log10 compared with the basal value, without undetectability
Rate of patients achieving HBs seroconversion 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 At weeks 8, 12 and through the end of treatment (average 3 years) Number of different HDV resistance variants Through treatment period, average 3 years Number of patients with at least one resistance variant Through treatment period, average 3 years Fibrosis level 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 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 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 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 At weeks 4, 8, 12 and through the end of treatment (average 3 years Rate of patients presenting an evolution towards hepatocellular carcinoma 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 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) in non-cirrhotic patients
Rate of patients presenting a decompensated cirrhosis 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) in non-cirrhotic patients
Change in HBs Ag from baseline 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 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) Biochemical response is defined as ALT and aspartate aminotransferase (AST) normalization
Rate of patients achieving hepatitis B e (HBe) Ag negativation in patient initially HBeAg- positive 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 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 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 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) Prolonged HDV RNA undetectability
Rate of patients achieving HBs Ag negativation 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 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)
Trial Locations
- Locations (38)
Bichat-Claude Bernard Hospital
🇫🇷Paris, France
Cochin Hospital
🇫🇷Paris, France
Hôpital Tenon
🇫🇷Paris, France
Beaujon Hospital
🇫🇷Clichy, France
CHU of Angers
🇫🇷Angers, France
Centre Hospitalier de la région annécienne
🇫🇷Annecy, France
Avicenne Hospital - Hepatology
🇫🇷Bobigny, France
Avicenne Hospital
🇫🇷Bobigny, France
Haut Lévêque Hospital
🇫🇷Bordeaux, France
Estaing Hospital
🇫🇷Clermont-Ferrand, France
Centre Hospitalier Intercommunal
🇫🇷Créteil, France
Henri Mondor Hospital
🇫🇷Créteil, France
Bocage Hospital
🇫🇷Dijon, France
Michallon Hospital
🇫🇷Grenoble, France
Claude Huriez Hospital
🇫🇷Lille, France
Dupuytren Hospital
🇫🇷Limoges, France
Croix Rousse Hospital
🇫🇷Lyon, France
Edouard Herriot Hospital
🇫🇷Lyon, France
Hôpital de la Croix Rousse
🇫🇷Lyon, France
SAint Joseph Hospital
🇫🇷Marseille, France
Saint Eloi Hospital
🇫🇷Montpellier, France
Hotel Dieu Hospital
🇫🇷Nantes, France
Hôtel-Dieu Hospital
🇫🇷Nantes, France
l'Archet 2 Hospital
🇫🇷Nice, France
La Source Hospital
🇫🇷Orléans, France
La Pitié Salpêtrière Hospital
🇫🇷Paris, France
Lariboisière Hospital
🇫🇷Paris, France
Pitié-Salpêtrière Hospital
🇫🇷Paris, France
Saint Antoine Hospital
🇫🇷Paris, France
Saint Louis Hospital
🇫🇷Paris, France
Saint-Antoine Hospital
🇫🇷Paris, France
Pontchaillou Hospital
🇫🇷Rennes, France
Charles Nicolle Hospital
🇫🇷Rouen, France
Nouvel Hôpital Civil
🇫🇷Strasbourg, France
Hôpital Rangueil
🇫🇷Toulouse, France
Rangueil Hospital
🇫🇷Toulouse, France
Trousseau Hospital
🇫🇷Tours, France
Paul Brousse Hospital
🇫🇷Villejuif, France