Eficácia e segurança da terapia com bulevirtida (BLV) em pacientes com hepatite Delta crônica (CHD) na Itália (D-SHIELD) (D-SHIELD)
Eficácia e segurança da terapia com bulevirtida (BLV) em pacientes com hepatite Delta crônica (CHD) na Itália: um estudo multicêntrico prospectivo de dados da 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.
Visão geral do estudo
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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MI
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Milan, MI, Itália, 20122
- Recrutamento
- Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
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Contato:
- Pietro Lampertico, MD
- Número de telefone: 0255035432
- E-mail: pietro.lampertico@unimi.it
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Hepatis Delta
Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously |
dose of 2 mg/day subcutaneously |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Describe the virological response to BLV in all patients starting BLV therapy for CHD
Prazo: 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
Prazo: Month 12
|
Percentage of patients with ≥ 2 log IU/ml decline of HDV RNA |
Month 12
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Month 6
|
Percentage of patients with normal ALT |
Month 6
|
|
Evaluation of the percentage of patients with normal ALT
Prazo: Month 12
|
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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: Month 12
|
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)
Prazo: Month 6
|
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)
Prazo: Month 12
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Change in serum levels albumin- by medians and ranges |
Month 12
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|
Investigation of changes over time in serum levels of platelets (10e9/L)
Prazo: 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)
Prazo: Month 12
|
Change in serum levels of platelets - by medians and ranges |
Month 12
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|
Investigation of changes over time in serum levels of AFP (µg/L)
Prazo: 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)
Prazo: Month 12
|
Change in serum levels of AFP - by medians and ranges |
Month 12
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|
Evaluation of treatment safety
Prazo: Month 6
|
Occurrence of change in serum bile acid levels (µmol/L) |
Month 6
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Evaluation of treatment safety
Prazo: Month 6
|
Occurrence of adverse events |
Month 6
|
|
Evaluation of treatment safety
Prazo: Month 12
|
Occurrence of change in serum bile acid levels (µmol/L) |
Month 12
|
|
Evaluation of treatment safety
Prazo: Month 12
|
Occurrence of adverse events |
Month 12
|
Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 184853
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