Efectividad y seguridad de la terapia con bulevirtida (BLV) en pacientes con hepatitis delta crónica (CHD) en Italia (D-SHIELD) (D-SHIELD)
Efectividad y seguridad de la terapia con bulevirtida (BLV) en pacientes con hepatitis delta crónica (CHD) en Italia: un estudio multicéntrico prospectivo con datos de la vida real
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.
Descripción general del estudio
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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MI
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Milan, MI, Italia, 20122
- Reclutamiento
- Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
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Contacto:
- Pietro Lampertico, MD
- Número de teléfono: 0255035432
- Correo electrónico: pietro.lampertico@unimi.it
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Hepatis Delta
Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously |
dose of 2 mg/day subcutaneously |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Describe the virological response to BLV in all patients starting BLV therapy for CHD
Periodo de tiempo: Month 6
|
Percentage of patients with undetectable HDV RNA |
Month 6
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|
Describe the virological response to BLV in all patients starting BLV therapy for CHD
Periodo de tiempo: Month 12
|
Percentage of patients with ≥ 2 log IU/ml decline of HDV RNA |
Month 12
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Month 12
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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
Periodo de tiempo: Month 6
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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
Periodo de tiempo: 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
Periodo de tiempo: Month 6
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Percentage of patients with normal ALT |
Month 6
|
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Evaluation of the percentage of patients with normal ALT
Periodo de tiempo: Month 12
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Percentage of patients with normal ALT |
Month 12
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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
Periodo de tiempo: Month 6
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Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) |
Month 6
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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
Periodo de tiempo: Month 12
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Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) |
Month 12
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|
Investigation of changes over time in serum levels of HBsAg (UI/mL)
Periodo de tiempo: Month 6
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Change in serum levels of HBsAg- by medians and ranges |
Month 6
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Investigation of changes over time in serum levels of HBsAg (UI/mL)
Periodo de tiempo: Month 12
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Change in serum levels of HBsAg- by medians and ranges |
Month 12
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|
Investigation of changes over time in serum levels of albumin (g/dL)
Periodo de tiempo: Month 6
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Change in serum levels albumin- by medians and ranges |
Month 6
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Investigation of changes over time in serum levels of albumin (g/dL)
Periodo de tiempo: Month 12
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Change in serum levels albumin- by medians and ranges |
Month 12
|
|
Investigation of changes over time in serum levels of platelets (10e9/L)
Periodo de tiempo: Month 6
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Change in serum levels of platelets - by medians and ranges |
Month 6
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Investigation of changes over time in serum levels of platelets (10e9/L)
Periodo de tiempo: Month 12
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Change in serum levels of platelets - by medians and ranges |
Month 12
|
|
Investigation of changes over time in serum levels of AFP (µg/L)
Periodo de tiempo: Month 6
|
Change in serum levels of AFP - by medians and ranges |
Month 6
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Investigation of changes over time in serum levels of AFP (µg/L)
Periodo de tiempo: Month 12
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Change in serum levels of AFP - by medians and ranges |
Month 12
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Evaluation of treatment safety
Periodo de tiempo: Month 6
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Occurrence of change in serum bile acid levels (µmol/L) |
Month 6
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Evaluation of treatment safety
Periodo de tiempo: Month 6
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Occurrence of adverse events |
Month 6
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Evaluation of treatment safety
Periodo de tiempo: Month 12
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Occurrence of change in serum bile acid levels (µmol/L) |
Month 12
|
|
Evaluation of treatment safety
Periodo de tiempo: Month 12
|
Occurrence of adverse events |
Month 12
|
Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 184853
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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