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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with co-infection with hepatitis B and Delta viruses, | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw for the laboratory assessment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the end of the follow-up, december 2027 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| COULIBALY Fatoumata | Contact | 0144236110 | +33 | fatoumata.coulibaly@anrs.fr |
| Claire FOUGEROU-LEURENT | Contact | claire.fougerou@chu-rennes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Fabien ZOULIM | Hôpital de la Croix-Rousse | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU of Angers | Recruiting | Angers | France |
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Blood samples
| 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) |
| Breakthrough rate | At weeks 8, 12 and through the end of treatment (average 3 years) |
| Rate of sustained virological response | HDV RNA undetectability | 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 | At weeks 4, 8, 12 and through the end of treatment (average 3 years) |
| 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 | in non-cirrhotic patients | 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 | 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 | 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 | 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 | 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 | Prolonged HDV RNA undetectability | 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 | 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) |
| Centre Hospitalier de la région annécienne | Not yet recruiting | Annecy | France |
|
| Avicenne Hospital - Hepatology | Recruiting | Bobigny | France |
|
| Avicenne Hospital | Recruiting | Bobigny | France |
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| Haut Lévêque Hospital | Recruiting | Bordeaux | France |
|
| Estaing Hospital | Recruiting | Clermont-Ferrand | France |
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| Beaujon Hospital | Recruiting | Clichy | France |
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| Centre Hospitalier Intercommunal | Recruiting | Créteil | France |
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| Henri Mondor Hospital | Recruiting | Créteil | France |
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| Bocage Hospital | Recruiting | Dijon | France |
|
| Michallon Hospital | Recruiting | Grenoble | France |
|
| Claude Huriez Hospital | Recruiting | Lille | France |
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| Dupuytren Hospital | Recruiting | Limoges | France |
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| Croix Rousse Hospital | Recruiting | Lyon | France |
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| Edouard Herriot Hospital | Recruiting | Lyon | France |
|
| Hôpital de la Croix Rousse | Recruiting | Lyon | France |
|
| SAint Joseph Hospital | Recruiting | Marseille | France |
|
| Saint Eloi Hospital | Recruiting | Montpellier | France |
|
| Hotel Dieu Hospital | Recruiting | Nantes | France |
|
| Hôtel-Dieu Hospital | Recruiting | Nantes | France |
|
| l'Archet 2 Hospital | Recruiting | Nice | France |
|
| La Source Hospital | Recruiting | Orléans | France |
|
| Bichat-Claude Bernard Hospital | Recruiting | Paris | France |
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| Cochin Hospital | Recruiting | Paris | France |
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| Hôpital Tenon | Recruiting | Paris | France |
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| La Pitié Salpêtrière Hospital | Recruiting | Paris | France |
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| Lariboisière Hospital | Not yet recruiting | Paris | France |
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| Pitié-Salpêtrière Hospital | Recruiting | Paris | France |
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| Saint Antoine Hospital | Recruiting | Paris | France |
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| Saint Louis Hospital | Recruiting | Paris | France |
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| Saint-Antoine Hospital | Recruiting | Paris | France |
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| Pontchaillou Hospital | Recruiting | Rennes | France |
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| Charles Nicolle Hospital | Recruiting | Rouen | France |
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| Nouvel Hôpital Civil | Recruiting | Strasbourg | France |
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| Hôpital Rangueil | Recruiting | Toulouse | France |
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| Rangueil Hospital | Recruiting | Toulouse | France |
|
| Trousseau Hospital | Recruiting | Tours | France |
|
| Paul Brousse Hospital | Recruiting | Villejuif | France |
|
| ID | Term |
|---|---|
| D019701 | Hepatitis D, Chronic |
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D003699 | Hepatitis D |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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