Efficacité et sécurité du traitement par bulévirtide (BLV) chez les patients atteints d'hépatite chronique delta (CHD) en Italie (D-SHIELD) (D-SHIELD)
Efficacité et sécurité du traitement par le bulévirtide (BLV) chez les patients atteints d'hépatite chronique delta (CHD) en Italie : une étude prospective multicentrique avec données réelles
Multicenter pharmacological observational prospective, no-profit, study.
This study was designed to get a "real-life" snapshot across several Italian Hepatology centers. All HDV patients are followed up according to EASL 2017 guidelines. This allows uniformity on the indication for antiviral treatment and management of that antiviral therapy. No off-label medications are used. All data are retrievable from the patient's medical record. In addition, clinical and biochemical data from patients at month 0, 1, 2, 4, 6 and 12 of treatment, and otherwise within the study period, will be collected longitudinally.
The primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy for CHD, defined as a >2 Log decline in HDV-RNA or undetectable HDV-RNA (using the Robogene 2.0 quantitative kit, LLQ <6 IU/ml) at month 12 of therapy.
HDV patients who will start therapy with BLV 2 mg/day from May 2023, according to AIFA guidelines, will be consecutively enrolled.
Aperçu de l'étude
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
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MI
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Milan, MI, Italie, 20122
- Recrutement
- Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
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Contact:
- Pietro Lampertico, MD
- Numéro de téléphone: 0255035432
- E-mail: pietro.lampertico@unimi.it
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
All patients with CHD (quantifiable HDV-RNA) who will start treatment with BLV 2 mg/day during the study period at the S.C. Gastroenterology and Hepatology (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico) and at participating centers, and who met the inclusion criteria and none of the exclusion criteria.
La description
Inclusion Criteria:
- 18 years of age or older
- Chronic hepatitis delta
- Compensated cirrhosis HDV related
- Patients who will start therapy with BLV 2 mg/day from May 2023
Exclusion Criteria:
- HDV-related decompensated cirrhosis (CPT ≥7)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Hepatis Delta
Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously |
dose of 2 mg/day subcutaneously |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Describe the virological response to BLV in all patients starting BLV therapy for CHD
Délai: Month 6
|
Percentage of patients with undetectable HDV RNA |
Month 6
|
|
Describe the virological response to BLV in all patients starting BLV therapy for CHD
Délai: Month 12
|
Percentage of patients with ≥ 2 log IU/ml decline of HDV RNA |
Month 12
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
Délai: Month 6
|
Proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA |
Month 6
|
|
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
Délai: Month 12
|
Proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA |
Month 12
|
|
Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA
Délai: Month 6
|
Proportion of patients with virological response, defined as undetectable HDV-RNA |
Month 6
|
|
Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA
Délai: Month 12
|
Proportion of patients with virological response, defined as undetectable HDV-RNA |
Month 12
|
|
Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
Délai: Month 6
|
Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT |
Month 6
|
|
Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
Délai: Month 12
|
Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT |
Month 12
|
|
Evaluation of the percentage of patients with normal ALT
Délai: Month 6
|
Percentage of patients with normal ALT |
Month 6
|
|
Evaluation of the percentage of patients with normal ALT
Délai: Month 12
|
Percentage of patients with normal ALT |
Month 12
|
|
Evaluation of the percentage of patients with clinical response, i.e., the percentage of patients who remain free of liver complications, such as HCC or decompensation
Délai: Month 6
|
Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) |
Month 6
|
|
Evaluation of the percentage of patients with clinical response, i.e., the percentage of patients who remain free of liver complications, such as HCC or decompensation
Délai: Month 12
|
Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) |
Month 12
|
|
Investigation of changes over time in serum levels of HBsAg (UI/mL)
Délai: Month 6
|
Change in serum levels of HBsAg- by medians and ranges |
Month 6
|
|
Investigation of changes over time in serum levels of HBsAg (UI/mL)
Délai: Month 12
|
Change in serum levels of HBsAg- by medians and ranges |
Month 12
|
|
Investigation of changes over time in serum levels of albumin (g/dL)
Délai: Month 6
|
Change in serum levels albumin- by medians and ranges |
Month 6
|
|
Investigation of changes over time in serum levels of albumin (g/dL)
Délai: Month 12
|
Change in serum levels albumin- by medians and ranges |
Month 12
|
|
Investigation of changes over time in serum levels of platelets (10e9/L)
Délai: Month 6
|
Change in serum levels of platelets - by medians and ranges |
Month 6
|
|
Investigation of changes over time in serum levels of platelets (10e9/L)
Délai: Month 12
|
Change in serum levels of platelets - by medians and ranges |
Month 12
|
|
Investigation of changes over time in serum levels of AFP (µg/L)
Délai: Month 6
|
Change in serum levels of AFP - by medians and ranges |
Month 6
|
|
Investigation of changes over time in serum levels of AFP (µg/L)
Délai: Month 12
|
Change in serum levels of AFP - by medians and ranges |
Month 12
|
|
Evaluation of treatment safety
Délai: Month 6
|
Occurrence of change in serum bile acid levels (µmol/L) |
Month 6
|
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Evaluation of treatment safety
Délai: Month 6
|
Occurrence of adverse events |
Month 6
|
|
Evaluation of treatment safety
Délai: Month 12
|
Occurrence of change in serum bile acid levels (µmol/L) |
Month 12
|
|
Evaluation of treatment safety
Délai: Month 12
|
Occurrence of adverse events |
Month 12
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 184853
Informations sur les médicaments et les dispositifs, documents d'étude
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